Anwendbare CPT / HCPCS / ICD-10 Codes
Aetna considers extracorporeal shock wave therapy (ESWT) to be clinically necessary for calcific tendinopathy of the shoulder lasting at least 6 months with a calcification deposit of 1 cm or more that has not responded to appropriate conservative therapies (p (e.g., rest, application of ice and medication).
Aetna considers Extracorporeal Shockwave Therapy (ESWT), Extracorporeal Pulse Activation Therapy (EPAT) (also known as Extracorporeal Soundwave Therapy) for the following indications (non-exhaustive list) to be experimental and under investigation as it does not there is sufficient evidence of the effectiveness of ESWT for these indications in the medical literature:
- angina pectoris
- bone marrow edema
- Lymphedema related to breast cancer
- Carpal tunnel syndrome
- Osteoarthritis of the carpometacarpal joint
- Chronic kidney disease (except kidney stones)
- Chronic obstructive pulmonary disease
- chronic pelvic pain
- chronic inflammation of the prostate
- late unions
- diabetic nephropathy
- Digital ulcers in systemic sclerosis
- erectile dysfunction
- Fabella syndrome
- Heterotopic Ossification
- hypertensive nephropathy
- Hypertrophic hand scars caused by burns
- idiopathic scoliosis
- window disease
- knee arthrosis
- Epicondilite Lateral (Tennisellenbogen)
- Pain in the lower back
- Lower extremity disorders (eg, Achilles tendinopathy, greater trochanteric pain syndrome, knee tendinopathy, medial tibial strain syndrome, patellar tendinopathy, and proximal calcaneal tendinopathy)
- Ulceration of the lower extremities (eg, venous leg ulcers)
- mandibular distraction
- Medial epicondylitis (golfer's elbow)
- Trapezius myofascial pain syndrome
- Myofascial Pelvic Pain Syndrome
- Neurogenic heterotopic ossification after craniocerebral trauma
- non-healing of fractures
- Osteochondral lesions of the talus
- Osteonecrosis of the femoral head
- Peyronie's disease
- Rotator cuff tendinitis (shoulder pain)
- Sacroiliac joint pain
- Ruptur des Schulterblattes (shoulder-thoracic bursitis).
- Spasticity associated with brain injury/stroke, cerebral palsy
- spinal cord injury
- The stress fracture
- Subacromial impingement syndrome/subacromial shoulder pain
- Wound healing (including burns and soft tissue wounds)
- Other musculoskeletal indications (eg, heel spur, hammer toe, tenosynovitis of the foot or ankle, and tibial tendonitis).
Aetna considers preoperative ESWT to reduce scarring after an abdominoplasty as experimental and experimental, as the effectiveness of this approach has not been demonstrated.
See tooCPB 0235 - Treatments for Plantar Fasciitis.
Extracorporeal shock wave therapy (ESWT) is a non-surgical treatment in which shock waves are delivered to musculoskeletal areas of the body (usually the epicondyle, shoulder or heel) with the aim of relieving pain and promoting soft tissue healing affected. The shockwaves are believed to reduce inflammation, dissolve scar tissue and encourage tissue healing. ESWT is performed on an outpatient basis and may use local anesthesia to numb the area targeted for treatment. ESWT is intended to be a non-invasive alternative to surgical treatment in selected patients who have not responded to conventional medical therapy.
Extracorporeal pulse activation therapy, or radial wave therapy, is another type of ESWT that uses pressure waves to convert kinetic energy into radially expanding shock waves. It should represent an alternative to focused ESWT and address larger treatment areas.
Lateral elbow pain (tennis elbow, lateral epicondylitis, rowing arm) is one of the most common repetitive motion injuries; The prevalence of lateral elbow pain in the general population is estimated at 1-3%. Symptoms usually last from 18 months to 2 years, and a small proportion of patients eventually undergo surgery.
This overuse syndrome is caused by sustained tension in the prehension muscles (extensor carpi radialis brevis and longus) and supination muscles (supinator carpi longus and shortus) of the forearm, which arise from the lateral epicondyle of the elbow.
Conservative treatment includes rest, ice, stretching, strengthening, and reducing intensity to allow for maladaptive changes. Any activity that causes pain on wrist extension or pronation should be avoided. With healing, exercises to strengthen the wrist extensors can be started. Exercises to strengthen the wrist flexor pronators are also commonly recommended.
The mechanism of action of extracorporeal shock wave therapy (ESWT) in the treatment of lateral elbow pain is not well understood. Techniques for applying extracorporeal shock wave therapy for musculoskeletal conditions are not yet standardized, and exact dosages and optimal frequency of use have not been extensively studied. There is still no consensus on when to distinguish between high- and low-energy shock wave applications. Other open questions include whether shockwaves should be guided to the target area by X-ray or ultrasound and whether injections of local anesthetic should be given to the target area prior to treatment to reduce pain reactions.
Buchbinder et al. (2005) published a systematic review of ESWT in lateral epicondylitis. Investigators identified 9 randomized controlled trials of ESWT versus placebo in lateral epicondylitis. Five of the studies showed that shock wave therapy improved pain, function and grip strength to the same extent or slightly greater than placebo. Four studies showed greater improvement with shockwave therapy than with placebo. As Buchbinder et al. (2005) pooling data from 9 studies, they found no statistically significant benefit of ESWT on lateral epicondylitis. The researchers concluded that "Based on a systematic review of nine placebo-controlled trials involving 1006 participants, there is 'platinum' level evidence that shockwave therapy has little or no benefit in terms of pain and function for lateral pain. of the elbow".
In a randomized controlled trial (n = 60), Chung and Wiley (2004) concluded that despite improvement in pain scores and maximum pain-free grip strength within groups, there does not appear to be a significant difference between groups using ESWT. in combination with the forearm stretching program and treatment with the forearm stretching program alone for pain relief within 8 weeks of starting treatment. Stasinopoulos and Johnson (2005) stated that further research with well-designed randomized controlled trials is needed to determine the absolute and relative effectiveness of ESWT in tennis elbow. Furthermore, Bisset et al. (2005) in a systematic review and meta-analysis of clinical trials of physical interventions for lateral epicondylalgia, state that ESWT is not beneficial in the treatment of tennis elbow.
A review by the BlueCross BlueShield Association's Technology Evaluation Center (2005) concluded that ESWT in lateral epicondylitis does not meet the criteria for ECT. The review stated that "overall, available data do not provide strong and consistent evidence that ESWT improves outcomes in chronic lateral epicondylitis".
Medial epicondylitis (golfer's elbow) is an overuse injury that affects the origin of the flexor-pronator muscle on the anterior medial epicondyle of the humerus. Medial epicondylitis is similar in many ways to the more common lateral epicondylitis. Both conditions are overuse tendinopathies that can be associated with racquet sports. Other activities associated with medial epicondylitis include golf, pitching, and racquet sports. This condition has also been reported in bowlers, archers and weight lifters. Pain worsens with wrist flexion and pronation activities. Patients may report discomfort even simply by squeezing someone's hand. A history of acute injury (eg, golf swing, baseball pitch, tennis hit) may be reported. Up to 50% of patients with medial epicondylitis complain of occasional or constant numbness and/or radiating tingling in the ring and ring fingers, suggesting ulnar nerve involvement.
A first study on ESWT in medial epicondylitis reported disappointing results (Krischek et al., 2001). This is confirmed by two randomized controlled trials. Haake et al (2002) concluded that ESWT was not effective in the treatment of lateral epicondylitis (n = 272). The previously reported success of this therapy appears to be due to inadequate study designs.
Melikyan et al. (2003) reported the results of a double-blind, randomized, controlled clinical trial of ESWT in 74 patients with epicondylitis. The researchers reported no significant differences between the treatment and placebo groups in terms of improvements in pain, function, or disability. The researchers concluded that "our study did not provide evidence that extracorporeal shock wave therapy for tennis elbow is better than placebo." A systematic review of the evidence concluded that the effectiveness of ESWT for tennis elbow is 'unknown' (Assendelft et al., 2003).
A review of ESWT in refractory tennis elbow by the National Institute for Clinical Excellence (NICE, 2009) concluded that, although the evidence for extracorporeal shock wave therapy in refractory tennis elbow does not raise major safety concerns, the evidence for its efficacy are conflicting. "Therefore, this procedure should only be used with special precautions for clinical management, consent, and audit or investigation."
The Canadian Agency for Medicines and Health Technology (CADTH) report on ESWT in chronic lateral epicondylitis (Ho, 2007a) stated that "lack of convincing evidence of its efficacy does not support the use of ESWT in lateral epicondylitis". The CADTH report on ESWT in chronic rotator cuff tendinitis (Ho, 2007b) stated that “the evidence reviewed for this bulletin supports the use of high-energy ESWT in chronic calcifying rotator cuff tendinitis but not in non-calcifying rotator cuff tendinitis. Qualitatively high-quality rotator randomized controlled trials (RCTs) with larger sample sizes are needed to provide stronger evidence".
Extracorporeal shockwave therapy has also been studied in other musculoskeletal applications, including Achilles tendinitis and shoulder tendinitis. Published articles on ESWT in Achilles tendonitis are limited to studies in animal models. There are no adequate prospective clinical studies demonstrating the effectiveness of ESWT in Achilles tendonitis. The National Institute for Health and Clinical Excellence (NICE, 2009) guidelines concluded that, although the evidence on extracorporeal shock wave therapy for refractory Achilles tendinitis does not raise major safety concerns, the evidence on the efficacy of the procedure is mixed. conflicting. "Therefore, ESWT should be used in refractory Achilles tendinopathy only with special precautions for clinical monitoring, consent, and testing or investigation."
Extracorporeal shock wave therapy has also been used to treat shoulder pain (calcific tendinitis of the shoulder). In a review of ESWT for the treatment of calcific and non-calcific rotator cuff tendinitis, Harniman et al. (2004) state that the common problem in this area of research was sample size, randomization, blinding and treatment provider bias, and outcome measures. 🇧🇷 The researchers found moderate evidence that high-energy ESWT is effective in treating chronic tendinitis due to rotator cuff calcifications when shock waves are focused on the calcifications. Furthermore, the researchers found moderate evidence that low-energy ESWT is not effective in the treatment of chronic non-calcific tendinitis of the rotator cuff, although this conclusion is based on only one low-quality, low-power study. These investigators concluded that high-quality randomized controlled trials with larger sample sizes, better randomization and blinding, and better outcome measures are needed to determine the effectiveness of ESWT in calcific and non-calcific rotator cuff tendinitis.
A review of extracorporeal shockwave therapy by the Washington State Department of Labor and Industries (2003) concluded that "the evidence for [ESWT's] efficacy in musculoskeletal disorders remains inconclusive." In a review of plantar fasciitis, Buchbinder (2004) noted that “ESWT has been proposed as an alternative approach because it can stimulate soft tissue healing and inhibit pain receptors. However, available data do not provide substantial support for its use."
A review prepared for the Ohio Office of Workers' Compensation (2005) concluded that "Studies have not shown consistent results or efficacy in the treatment of plantar fasciitis, epicondylitis, and non-calcal tendinitis of the shoulder. ESWT is considered absent." services." The review noted that while "the use of ESWOT in the treatment of radiographically confirmed calcific tendonitis of the shoulder shows good preliminary results", that "[r]ape the results with studies in the Prior Notice would be beneficial for adoption."
In a single-blind, randomized, controlled study, Engebretsen et al. (2011) reviewed the results of radial TOCH (ESWT) and supervised exercise (SE) offered to patients with subacromial shoulder pain at one year. A total of 104 patients with subacromial shoulder pain lasting at least 3 months were included in this study. Patients were randomly assigned to an rESWT group (n = 52) or an SE group (n = 52). The rESWT intervention consisted of a weekly session for 4 to 6 weeks. The SE intervention consisted of 2 sessions of 45 minutes per week for a maximum of 12 weeks. The primary endpoint was the shoulder pain and disability index. Secondary endpoints were questions about pain, function, and work status. At 1 year, an intention-to-treat analysis showed no significant difference between the two groups for the primary outcome (-7.6 points, 95% confidence interval [CI] -16.6 to 0.5) and pain, function and medication. Twenty-nine participants (60%) in the SE group versus 24 participants (52%) in the rESWT group were classified as clinically improved. Thirty-eight participants in the SE group were working compared to 30 participants in the rESWT group (odds ratio = 1.1, 95% CI 1.0 to 1.2). Fewer patients in the SE group received additional treatments between 18 weeks and 1 year. The authors concluded that no significant differences were found between the SE and rESWT groups at the 1-year follow-up. More SE group participants returned to work.
Over the past decade, TOCH has become a common tool for treating non-union workers. Break et al. (2001) reported that although high-energy shockwave therapy appears to be an effective, non-invasive tool to promote bone healing in appropriately selected patients with diaphyseal or metaphyseal pseudarthrosis of the femur or tibia, controlled studies are needed. 🇧🇷 Birnbaum et al. (2002) found in a review of the use of ESWT in the treatment of nonunions that ESWT is not yet a standard therapeutic technique in orthopedics. These investigators concluded that the main goal of future research should be the evaluation of appropriate energy densities and pulse rates for different indications according to evidence-based medicine. Well-designed studies with long-term follow-up are needed before TOCH can be compared with established methods.
Biederman et al. (2003) observed that non-union remains one of the main complications after skeletal trauma. However, no prospective randomized studies have been performed to date to demonstrate the effectiveness of this form of treatment. The authors concluded that there is no evidence to support the treatment of nonunions with ESWT. Before a final decision can be made on this indication for ESWT, a prospective randomized clinical trial with a control group must be conducted. An evaluation prepared for the Ohio Bureau of Workers' Compensation (2004) concluded that more studies of OCH among nonunion workers are needed.
Available brands of ESWT devices include OssaTron (HealthTronics, Marietta, GA), Dornier Epos Ultra (Dornier Medical Systems, Kennesaw, GA) and Sonocur (Siemens Medical Solutions Inc., Iselin, NJ).
Corda et al. (2006) noted that shock waves, used in urology and gastroenterology, were introduced in Germany in the middle of the last decade to treat various musculoskeletal pathologies, including epicondylitis of the elbow, plantar fasciitis, and calcification and non-calcific tendinitis of the rotator cuff. . Given the non-invasive nature of these waves and their apparently low complication rate, ESWT appears to be a promising alternative to established conservative and surgical options in the management of patients with painful chronic conditions. However, the obvious advantages of the method led to the rapid spread and even inflationary use of TOCH. The authors state that prospective and randomized studies on the mechanisms and effects of shock waves on musculoskeletal tissues are urgently needed to define more precise indications and optimize the therapeutic result.
In a double-blind, randomized, placebo-controlled study, Staples et al. (2008) whether ultrasound-guided ESWT in patients with lateral epicondylitis (tennis elbow) reduces pain and improves function in the short and medium term. A total of 68 community-referred patients were randomized to receive 3 ESWT treatments or 3 treatments at a subtherapeutic dose administered at weekly intervals. Seven endpoints related to pain and function were collected at follow-up visits 6 weeks, 3 months, and 6 months after completion of treatment. Mean changes in outcome variables from baseline to 6 weeks, 3 months, and 6 months were compared for the two groups. The groups did not differ in demographics or clinical characteristics at baseline, and there were significant improvements in nearly all outcome measures for both groups during the 6-month follow-up period, but there were no differences between groups even after accounting for duration. of the symptoms. 🇧🇷 The authors concluded that these results provide little evidence for the use of ESWT to treat lateral epicondylitis and are consistent with recent systematic reviews of ESWT in lateral epicondylitis, which reached similar conclusions.
Schleicher et al. (2010), in a review of epicondylitis treatment, noted that the choice of different treatments is difficult to ignore and that there are few good clinical studies that support a treatment option with evidence-based drugs. In the acute phase, topical nonsteroidal anti-inflammatory drugs, steroid injections, ultrasound, and acupuncture are helpful. There is no consensus on the effectiveness of physiotherapy, orthoses, laser, electrotherapy or botulinum toxin injections. During the chronic phase, none of the different treatment modalities are effective according to evidence-based medicine criteria. It remains to be seen whether patients benefit from physical therapy, orthoses, ESWT, or surgery during this time.
Hearnden and colleagues (2009) found that ESWT is an effective non-invasive treatment for chronic supraspinatus tendon calcifications. However, many studies have been criticized for not meeting the required scientific standards. In a prospective, single-blind, randomized study of 20 patients, these investigators examined the effectiveness of therapy. Subjectively, 45% of treated patients were satisfied with the result and also objectively increased their Constant Score by 11% after 6 months. The control group showed no subjective or objective improvement (p<0.03). This study confirmed that ESWT is effective in treating chronic calcific tendinitis compared to a placebo group. However, according to the authors' experience, it is not as successful as previously stated, as 50% of patients do not obtain satisfactory results and require surgical removal. Additionally, patients found the procedure painful, which was not mentioned above.
Damage et al. (2007) evaluated the feasibility and safety of ESWT in acute and chronic soft tissue wounds. A total of 208 patients with acute and chronic complicated non-healing soft tissue wounds were prospectively included in this study. Treatment consisted of debridement, outpatient ESWT [100 to 1000 shocks/cm(2) at 0.1 mJ/mm(2), depending on wound size, every 1 to 2 weeks for an average of 3 treatments] and dressings . Thirty-two (15.4%) patients withdrew from the study after the first ESWT and were analyzed on an intent-to-treat basis as incomplete cure. Of the 208 patients included, 156 (75%) had 100% wound epithelialization. There was no treatment-related toxicity, infection, or deterioration of an ESBT-treated wound during the median follow-up of 44 days. The multivariable intention-to-treat analysis identified age (p=0.01), wound less than or equal to 10 cm(2) (p=0.01; odds ratio [OR]=0.36; 95% CI: 0. 16 to 0.80) and duration less than or equal to 1 month (p<0.001; OR=0.25; 95% CI: 0.11 to 0.55) as independent predictors of complete cure. The authors concluded that the ESWT strategy is feasible and well tolerated by patients with acute and chronic soft tissue injuries. They noted that ESWT is being evaluated in a phase III trial for acute traumatic wounds.
Alves et al. (2009) stated that osteonecrosis is a progressive clinical condition with significant morbidity, primarily affecting weight-bearing joints and characterized by the death of bones or parts of bones due to insufficient blood flow. The hip is the most commonly affected joint. In osteonecrosis of the femoral head (ONFH), collapse of the femoral head results from mechanically weak, weight-bearing bone and can be associated with disabling pain and immobility. Both surgical and non-surgical options have been used with varying success, and non-surgical treatment modalities such as bisphosphonates, statins, anticoagulants and ESWT have been described for early-stage disease, but the precise indications have not been described. still established. The aim of this study was to conduct a systematic review of the use of ESWT in the treatment of ONFH. The Medline, Lilacs and Scielo databases were searched using the keywords shock wave, osteonecrosis, avascular necrosis, aseptic necrosis and femoral head. The search period was between 1966 and 2009. Only 5 items were obtained that met the previously established criteria. Of these 5 articles, 2 were RCTs, 1 open study, 1 prospective comparative study and 1 case report. This review showed that there are no controlled, double-blind studies on the effectiveness of ESWT in the treatment of ONFH. On the other hand, published uncontrolled studies seem to show some favorable results, justifying further research in this area.
Larking et al. (2010) examined whether ESWT increases the cure rate in patients with chronic neurological diseases and chronic pressure ulcers. Ulcers were randomized to receive ESWT or placebo for 4 weeks, followed by a 2-week washout period, followed by a 4-week crossover/placebo period. The main outcome measure was the measurement of the area of ulceration. The average of 3 measurements was taken for each observation. A total of 9 ulcers (in 8 patients) were included in the study: 5 on the buttocks/sacrum/trochanter and 4 on the feet/ankles. All patients with chronic static ulcers showed better healing 6 to 8 weeks after starting ESWT, regardless of whether they were first treated with placebo or therapy. The authors concluded that ESWT has a potential role in the treatment of chronic cutaneous ulcers. The results of this small study need to be validated by well-designed studies.
Zelle and colleagues (2010) provided a concise overview of the fundamentals of ESWT and performed a systematic literature review on the use of ESWT in the treatment of fractures and late fractures/nonunions. Articles in English or German were identified for systematic review by searching PubMed-Medline from 1966 to 2008, the Cochrane Database of Systematic Reviews, the Cochrane Database of Abstracts of Effects Reviews, the Cochrane Central Register of Controlled Trials, and relevant meeting abstracts were 2007 to 2008. In addition, the bibliographies of the identified articles were reviewed. These investigators included clinical outcome studies of ESWT in the treatment of fractures and delayed healing/non-healing. Reports with less than 10 patients were excluded. Pseudarthrosis after corrective osteotomies or arthrodesis were excluded. Sample size, level of evidence, definition of delayed healing, definition of nonunion, time from injury to shock wave treatment, fracture location, healing rate, and complications. Data on 924 patients undergoing ESWT for delayed/non-healing healing were drawn from 10 studies. All articles were classified as level 4 studies. The overall retention rate was 76% (95% CI 73% to 79%). The healing rate was significantly higher in hypertrophic nonunions than in atrophic nonunions. The authors concluded that data from the Level 4 studies suggest that ESWT appears to stimulate the healing process in delayed or absent healing. However, they noted that more research is needed.
The National Institute for Health and Clinical Excellence (NICE, 2011) Consultation on Interventional Procedures concluded that the evidence for the safety and efficacy of ESWT in greater trochanteric pain syndrome is of limited quality and quantity. Refractory greater trochanteric pain syndrome. Research studies must clearly describe patient selection, imaging studies, and treatment protocols. Results should include functional and quality of life scores with a minimum follow-up of 1 year.
Break et al. (2009) reported a comparative study of 229 subjects with refractory unilateral trochanteric pain syndrome who were sequentially assigned to a home exercise program, a single local corticosteroid injection (prednisolone 25 mg), or repeated low-energy radial discharge. Wave treatment participants underwent outcome assessments at baseline, 1, 4, and 15 months. Primary outcomes were degree of recovery, measured on a 6-point Likert scale (individuals achieving full or much better recovery were scored as treatment success) and last week pain intensity (0 to 10 points) after 4 months. Side dish. One month after initiation, results after corticosteroid injection (75% success rate; pain score, 2.2 points) were significantly better than results after home exercises (7%; 5.9 points) or shock wave therapy (13%; 5.6 points). 🇧🇷 Regarding treatment success after 4 months, radial shockwave therapy showed significantly better results (68%; 3.1 points) than home exercises (41%; 5.2 points) and corticosteroid injection (51 points). %; 4.5 points). Fifteen months after entry into the study, radial shock wave therapy (74%; 2.4 points) and home exercises (80%; 2.7 points) were significantly more successful than corticosteroid injection ( 48%; 2.7 points; 5.3 points). The authors reported that the significant short-term superiority of a single corticosteroid injection over home exercise and shock wave therapy diminished after 1 month. The authors reported that both corticosteroid injection and home exercises were significantly less successful than shockwave therapy at 4 months. Corticosteroid injection was significantly less successful than home exercise or shockwave therapy at the 15-month follow-up.
In a prospective, randomized, controlled study, Chitale et al. (2010) reviewed limited ESWT with sham therapy in men with Peyronie's disease. A total of 36 men were randomized to 6 sessions of ESWT or sham treatment. Geometric measurements of penile length and deformity, abbreviated International Index of Erectile Function (IIEF) score, and visual analogue score (VAS) were recorded and reassessed at 6 months. The patient and the evaluator were unaware of the nature of the treatment. Standardized non-parametric tests were used for statistical analysis. A complete set of outcome data was obtained for 16 patients in the intervention group and 20 in the placebo/control group (mean age 58 and 60 years; mean duration of symptoms 15 and 33 months, respectively). There were no significant differences in mean change between the control and intervention groups for any outcome measure. There were improvements in mean lateral (SD) and dorsal angles of 5.3 (11.66) degrees and 3.5 (17.38) degrees in the control group and a deterioration of 0.9 (16.01) degrees and 0. 9 (15.56) degrees in the ESWT group. Mean improvements in folded and straight lengths were 0.2 (0.58) and 0.1 (0.8) cm over control, and mean reductions of 0.1 (0.9) and 0.1 ( 1.49) cm in the TOCH group. Mean changes in IIEF and VAS scores were 0.1 (3.32) and -0.8 (1.77) for the control group and 0.56 (2.6) and -1.05 (1.79) for the TOCH group. The authors concluded that there were no significant differences in variable changes in Peyronie's disease treated with short-term ESWT.
In a systematic review, Seco et al. (2011) reviewed the evidence on the efficacy, efficacy, cost-effectiveness, and safety of ultrasound and shockwave therapy for the treatment of low back pain (LBP). An electronic search of MEDLINE, EMBASE, and the Cochrane Library databases was performed through July 2009 to identify RCTs comparing vibrotherapy to placebo or other treatments for back pain. No language restrictions apply. Additional data were requested from the authors of the original studies. The risk of bias for each study was assessed according to the criteria recommended by the Cochrane Back Review Group. A total of 13 studies were identified. The 4 RCTs that met the inclusion criteria included 252 patients; Two out of three ultrasound RCTs showed a high risk of bias. In acute patients with low back and leg pain secondary to disc herniation, ultrasound, traction, and low-power lasers have produced similar results. In patients with chronic low back pain without leg pain, ultrasound was less effective than spinal manipulation, whereas a shock wave device and transcutaneous electrical nerve stimulation gave similar results. Results from the only study comparing ultrasound to a sham procedure are unreliable due to the inadequacy of the sham procedure, small sample size, and lack of adjustment for potential confounders. No studies evaluated cost-effectiveness; No adverse events were reported. The authors concluded that the available evidence does not support the effectiveness of ultrasound or shock waves in the treatment of low back pain. They indicated that high-quality RCTs are needed to assess their effectiveness compared to appropriate sham procedures, and their effectiveness and cost-effectiveness compared to other procedures that have been shown to be effective in low back pain. In the absence of such evidence, the clinical use of these treatments is not warranted and should be discouraged.
In a phase II clinical trial, Ottomann et al. (2012) The effects of shock waves on burns. A predefined cohort of 50 patients (6 with incomplete data or lost to follow-up) with acute second-degree burns from a larger study of 100 patients were randomized to standard care (burn debridement) between December 2006 and December 2007. / topical antiseptic therapy) with (n = 22) or without (n = 22) unfocused ESWT (100 counts/cm at 0.1 mJ/mm) applied once to the study burn post-debridement. The randomization sequence was computer generated and patients were blinded to treatment assignment. The primary endpoint, time to complete burn epithelialization, was determined by an independent blinded observer. Worst case was applied to missing cases to exclude the effects of backtracking bias. Patient characteristics in the two study groups were balanced (p > 0.05), with the exception of advanced age (53 +/- 17 vs. 38 +/- 13 years, p = 0.002) in the OCBT group. The mean time to complete (greater than or equal to 95%) epithelialization (EC) for patients undergoing and not undergoing ESWT was 9.6 +/- 1.7 and 12.5 +/- 2, respectively, 2 days (p<0.0005). When age (continuous variable) and treatment group (binary) were examined in a linear regression model to control for an imbalance between baseline age and time to CD, age was not significant (p=0.33) and the treatment group maintained its significance (p< 0.0005). Statistical significance (p = 0.001) was maintained when unfollowed ESWT cases were assigned the longest time to CE and when unfollowed controls were assigned the shortest time to CE. The authors concluded that in this randomized phase II study, the application of a single defocused shockwave treatment to the superficial second-degree burn wound after debridement/topical antiseptic therapy significantly accelerated epithelialization. They indicated that this finding merits confirmation in a larger phase III study. Disadvantages of this study included the lack of burn histology, modest sample size, and lack of long-term follow-up.
Kearney and Costa (2010) reviewed the evidence for specific interventions for Achilles tendon insertional tendinopathy. Medline and the Cochrane Library were searched using a predefined search strategy. All study designs except case studies, narrative reviews, technical notes, and personal letters/opinions were included. Results were independently assessed by 2 reviewers and compared against inclusion/exclusion criteria. All included articles were assessed for methodological quality and study characteristics were extracted in a table. A total of 118 articles were identified by the search strategy, of which 11 met the selection criteria. Six studies examined surgical techniques after unsuccessful conservative treatment and five examined only conservative interventions. The overall level of evidence was limited to reviews of case series and 1 RCT. The authors concluded that there is a consensus that conservative methods should be used before surgical intervention. Current evidence for conservative treatment favors eccentric loading and shock wave therapy, although there is limited evidence to assess their effectiveness. The evaluation of surgical interventions was carried out mainly retrospectively and remains inconclusive.
An UpToDate review of “Achilles Tendinopathy and Tendon Rupture” (Ham and Maughan, 2013) notes that “further studies are needed to determine the role of shockwave therapy and topical nitrates. Surgical treatment of chronic tendinopathy may be considered in refractory cases, but it is not well studied.
Gaida and Cook (2011) noted that patellar tendon syndrome is a painful knee injury due to overuse that is common in jumping athletes. As exercise breaks are not a viable or effective treatment for patellar tendon syndrome in elite athletes, active treatment options are needed. Treatment can be conservative, based on injections, or surgical. This review summarizes the results of 32 studies of varying quality published between 2001 and 2011. Painful eccentric squat with 25°-The descent plate is compatible as a first-line treatment. Extracorporeal shockwave therapy is no more effective than placebo. Sclerosing injections appear to be effective, but the evidence is inconclusive. Scraping of abnormal tissues by arthroscopic surgery guided by real-time ultrasound is superior to sclerosing injections. Steroid injections are inferior to physical intervention and are not recommended. Autologous blood, platelet-rich plasma, and hyperosmolar dextrose injections are unproven and experimental.
Larson et al. (2012) systematically reviewed, summarized, and compared treatments for patellar tendon syndrome from published RCTs. Databases of prospective RCTs comparing treatment modalities for patellar tendon syndrome were searched. The 13 articles considered relevant were analyzed according to quality assessment guidelines and levels of evidence. Strong evidence was found supporting the use of eccentric training to treat patellar tendon syndrome. Moderate evidence was found in favor of conservative treatment (slow and intense resistance training) as an alternative to eccentric training. Moderate evidence indicated that treatment with low-intensity pulsed ultrasound did not affect treatment outcomes. Limited evidence was found for surgery, sclerosing injections and shock wave therapy. The authors concluded that physical training, and eccentric training in particular, seems to be the treatment of choice for patients with patellar tendon syndrome. However, the type of exercise, frequency, load and dose must also be considered. Other treatment modalities, such as surgical treatment, sclerosing injections, and shockwave therapy, need to be studied further before recommendations can be made about their use. Ultrasound can probably be ruled out as a treatment for patellar tendon syndrome. There is a persistent lack of well-designed studies with long-term follow-up and sufficient numbers of patients to draw firm conclusions about the therapy.
Furthermore, an UpToDate review of "Plantar Fasciitis and Other Causes of Heel Pain" (Buchbinder, 2013) notes that "In patients without sufficient improvement from baseline measures, more expensive therapies may be considered, although they have not yet been tested. .. shoe insoles (orthotics), night splints, cast immobilization, extracorporeal shock wave therapy… The effectiveness of extracorporeal shock wave therapy for plantar fasciitis has been studied more extensively than any other single treatment modality. Several randomized trials compared shockwave therapy with placebo or subtherapeutic doses of shockwaves. These trials were of varying methodological quality and reported conflicting results. A systematic review published in 2005 included 11 trials and performed a pooled analysis of data from six studies involving 897 patients. The authors concluded that, despite a statistically small benefit morning pain less than 0.5 cm on a 10 cm visual analogue scale, there is no clinically significant benefit from shockwave therapy. In a sensitivity analysis that included only high-quality studies, no statistically significant benefit was found. A later study using a low-energy pneumatic extracorporeal device also reported that shockwave treatment results were no better than sham therapy in a study of 25 participants. Clinical uncertainty remains about the effectiveness of shock wave therapy; Opinions are highly polarized, fueled by the lack of convergence in the results of random assessments. Explanations put forward to explain the different results include differences in methodological quality, different types of devices used to generate the shockwaves, different delivery methods, and different doses.
More recently, a variant of ESWT, also known as extracorporeal impulse activation therapy (EPAT) and extracorporeal acoustic wave therapy, has been proposed for orthopedic disorders and soft tissue inflammation. This pulse-activated, low-energy shockwave technology is said to be based on a unique set of pressure waves that stimulate metabolism, improve circulation, and speed up the healing process. Damaged tissue gradually regenerates and eventually heals.
The Work Loss Data Institute clinical guidelines for Ankle and Foot (Acute and Chronic) (2013) and Elbow (Acute and Chronic) (2013) listed ESWT as one of the interventions/procedures considered but currently not recommended. Additionally, the Work Loss Data Institute clinical guidelines on burns (2013) and knee and leg (acute and chronic) cite ESWT as one of the interventions/procedures being studied and not specifically recommended.
Calcific tendonitis is a condition that causes a small calcium deposit, usually 1 to 2 cm in size, to form in the rotator cuff tendons. These calcium deposits are usually found in patients who are at least 30 to 40 years old and are more common in diabetics. Treatment for calcific tendonitis usually includes rest, ice application, and medication.
In an RCT, Pan and colleagues (2003) evaluated the therapeutic effect of ESWT on shoulders with chronic calcific tendonitis, compared the functional outcomes of ESWT and transcutaneous electrical nerve stimulation (TENS) therapy, and examined which types of calcium effectively respond to ESWT . 🇧🇷 A total of 60 patients with persistent shoulder pain for 6 months or more and radiographically and ultrasonographically confirmed calcific tendonitis were included in this study. Patients were randomized to either ESWT (33 shoulders) or TENS (30 shoulders) treatment. Extracorporeal shock wave therapy was performed with 2,000 shock waves at 2 Hz and an energy level between 0.26 and 0.32 mJ/mm(2) per session. The treatment was carried out in 2 sessions 14 days apart. Transcutaneous electrical nerve stimulation was administered 3 times a week for 4 weeks. Key outcome measures included mean Constant Score, VAS, hand muscle testing, and changes in sonographic size and shape of calcium deposits calculated for 4 time points: baseline, 2 weeks, 4 weeks, and 12 weeks after therapy. In both groups, Constant score and VAS significantly improved at the 2-, 4-, and 12-week follow-ups (p<0.05), and the size of calcium deposits significantly decreased at the 4- and 12-week weekly follow-ups. Furthermore, arcuate rotator cuff calcified plaques improved significantly with ESWT. The authors concluded that ESWT is more effective than TENS therapy in the treatment of chronic calcific tendonitis of the shoulder, particularly in scalloped calcified plaque.
Dingemanse et al. (2014) presented an evidence-based review of the effectiveness of electrophysical treatment modalities in medial and lateral epicondylitis (PE). PubMed, EMBASE, CINAHL, and Pedro searches were performed to identify relevant RCTs and systematic reviews. Two reviewers independently extracted data and assessed methodological quality. A synthesis of the best evidence was used to summarize the results. A total of 2 reviews and 20 RCTs were included, all related to PE. Several electrophysical therapies have been evaluated: ultrasound, laser, electrotherapy, ESWT, TENS, and pulsed electromagnetic field therapy. Moderate evidence was found for the effectiveness of ultrasound versus placebo at mid-term follow-up. Short-term aftercare, ultrasound plus friction massage showed moderate evidence of efficacy compared with laser therapy. In contrast, we found moderate evidence in favor of laser therapy over plyometric exercise for short-term follow-up. For all other modalities, we found limited/conflicting evidence of efficacy or evidence that there was no difference in effect. The authors concluded that the potential efficacy of ultrasound and laser for the treatment of PE had been found. Furthermore, they stated that high-quality RCTs examining different intensities, as well as studies focusing on long-term follow-up outcomes, are needed to draw more definitive conclusions.
In a systematic review and meta-analysis, Ioppolo et al. (2013) evaluated the effectiveness of shockwave therapy (SWT) for functional improvement and pain reduction in patients with calcific tendonitis of the shoulder and determined the rate of disappearance of calcifications by shockwaves. after therapy at 6-month follow-up. The Cochrane Library, MEDLINE, Embase, CINAHL and the Ovid database were searched for articles. These investigators included RCTs from 1992 to 2011, and their quality was assessed using the Physiotherapy Evidence Database (PEDro) scale. The studies were evaluated by 2 independent experts for their methodological quality. Disagreements were resolved by a third reviewer. Data were then extracted and checked for accuracy. The reviewers were not blinded to the authors of the articles. In 4 of the 6 studies included for review, calcification resorption was assessed by meta-analysis because the studies had 2 treatment groups, while the other 2 studies were analyzed descriptively because they had 3 treatment groups. Fixed and random effects models were used to meta-analyze complete and partial absorption ratios, and I(2) statistics were calculated to assess heterogeneity. The authors found clinical improvement with a combined total absorption rate of 27.19 (95% CI: 7.20 to 102.67) and a combined partial absorption rate of 16.22 (95% CI: 3.33 to 79 ,01). They stated that SWT increases shoulder function, reduces pain and is effective in dissolving calcium deposits. These results were maintained for the next 6 months.
In a systematic review, Bannuru et al. (2014) the effectiveness of ESWT in patients with calcific and non-calcific tendonitis of the shoulder. We searched MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, Web of Science, and Google Scholar through November 1, 2013 for no calcifications. Shoulder tendonitis was selected for analysis. Outcome measures included pain (VAS score), functional assessment (Constant-Murley score), and resolution of calcifications. Three independent reviewers abstracted the data and determined adequacy and quality by consensus. A total of 28 RCTs met the inclusion criteria. The studies were heterogeneous; 20 RCTs compared the energy levels of ESWT and placebo and consistently showed that high-energy ESWT was significantly better than placebo in reducing pain and improving function and calcium absorption in calcific tendonitis. No significant differences were found between ESWT and placebo in the treatment of non-calcifying tendonitis. The authors concluded that high-energy ESWT is effective in improving pain and shoulder function in chronic calcific tendinitis of the shoulder and may result in complete resolution of calcifications. This therapy may be underused in a condition that may be difficult to manage.
Verstraelen et al. (2014) performed a systematic review and meta-analysis of randomized trials to answer two clear research questions:
- At 3 months and 6 months, is there a greater increase in Constant-Murley score in patients treated with high-energy ESWT compared to patients treated with low-energy ESWT? Y
- At 3 months and 6 months, is there a greater likelihood of complete resorption of calcifications in patients treated with high-energy ESWT compared to patients treated with low-energy ESWT?
We systematically searched five relevant online electronic databases, Medline (via PubMed), EMBASE (via OVID), Cinahl (via EBSCO), Web of Science and the Cochrane Central Register of Controlled Trials. These investigators also checked the reference lists of articles and reviews for potentially relevant studies. All RCTs comparing high-energy ESWT (greater than 0.28 mJ/mm2) with low-energy ESWT (less than 0.08 mJ/mm2) were eligible for inclusion. One author reviewed the titles and abstracts of each identified study to assess study eligibility. Two reviewers independently extracted data and assessed risk of bias and study quality. The primary outcome measure, the Constant-Murley score, was assessed by comparing the means of functional outcomes between groups. Secondary endpoints were evaluated by OR, where appropriate data were pooled. Based on this process, 5 RCTs (359 participants) were included. All 5 RCTs showed greater improvement in functional outcome (Constant Murley score) in patients treated with high-energy ESWT compared to patients treated with low-energy ESWT at 3 and 6 months. The mean difference at 3 months was 9.88 (95% CI 9.04 to 10.72, p<0.001; data at 6 months could not be pooled). Furthermore, high-energy ESWTs more often led to complete resorption of deposits after 3 months. The corresponding OR was 3.40 (95% CI 1.35 to 8.58) and p=0.009 (6-month data could not be pooled). The authors concluded that when shockwave therapy is chosen, high-energy shockwave therapy is more likely to improve Constant-Murley score and debris resorption than low-energy therapy.
Additionally, the Work Loss Data Institute clinical guideline “Shoulder (Acute and Chronic)” (2013) listed ESWT as one of the considered and recommended interventions/procedures.
The guidelines for treating rotator cuff syndrome in the workplace (Hopman, et al., 2013) state that over the past decade, several studies have suggested that the use of extracorporeal shock wave therapy can successfully treat rotator cuff syndrome. rotator cuff. The guidelines state that EWST generates pressure waves that supposedly induce the breakdown of calcium stores and stimulate their reabsorption. The low-energy form of these waves is believed to relieve pain, while the high-energy waves increase regional blood flow, cause capillary damage and the growth of new capillaries. Guidelines indicate that this treatment for calcific tendonitis can be painful and usually requires local anesthesia for the patient to tolerate. Contraindications for this therapy are pregnancy, pacemakers or anticoagulant medications.
On the other hand, an UpToDate review on “rotator cuff tendinopathy” (Simons & Kruse, 2014) lists ESWT as one of the experimental treatments.
In a meta-analysis, Lee and colleagues (2014a) assessed the effects of ESWT on reducing spasticity immediately and 4 weeks after ESWT application. These investigators searched PubMed, TCL, Embase, and Scopus from their start dates through June 2013. The keywords "muscular hypertonia OR spasticity" were used for spasticity and the keywords "shock wave OR ESWT" for ESWT. A total of 5 studies were finally included in the meta-analysis. Modified Ashworth Scale (MAS) scores improved significantly immediately after ESWT compared to baseline (standardized mean difference (SMD), -0.792, 95% CI -1.001 to -0.583). MAS grade 4 weeks after ESWT was also significantly improved compared to baseline (SMD, -0.735; 95% CI -0.951 to -0.519). The authors concluded that ESWT has a significant effect on improving spasticity. In addition, they indicated that greater standardization of treatment protocols, including treatment intervals and intensities, and long-term follow-up studies were needed.
In chronic spinal cord injury (SCI), the efficacy of cell transplantation is known to be low due to its marked pathology. Microenvironmental change was tested using ESW for chronic SCI. In an animal study, Lee et al. (2014b) presented experimental evidence for cell therapy in spinal cord injury. A model of SCI with chronic contusion was performed in 36 Sprague-Dawley rats. The mice were distributed
- control group (SCI only),
- ESW Control Group (SCI + ESW),
- Group IV (SCI + intravenous mesenchymal stem cell transplantation; MSC) and
- Group ESW + IV (transplant SCI + MSCs IV to ESW).
Extracorporeal shock waves were applied with the energy determined in preliminary tests. Cell engraftment and expression of growth factors (brain-derived neurotrophic factor, neuronal growth factor) and cytokines (SDF-1, CXCR4, vascular endothelial growth factor [VEGF]) in the epicenter were evaluated. The Basso, Beattie and Bresnahan scale of movement was used for clinical evaluation. The average number of engrafted cells was higher in ESW + IV than in IV with statistical significance. SDF-1 expression was higher in the ESW groups than in the control or IV groups; CXCR4 was highly expressed in the transplanted groups. The expression of growth factors in the treated group was higher in the treated group than in the control group. However, several statistical significances were observed. The improvement in the musculoskeletal system was greater in the transplanted groups than in the control group and ESW only. The authors concluded that, at a given energy level, ESW engrafted more transplanted MSCs without clinical worsening of the chronic spinal cord injury. They indicated that, based on this promising result and possible explanations, ESW could cause a change in the microenvironment for cell therapy in chronic spinal cord injuries.
Yamaya et al. (2014) investigated whether low-energy ESWT promotes VEGF expression and neuroprotection and improves locomotor recovery after SCI. A total of 60 adult female Sprague-Dawley rats were randomized into 4 groups:
- sham group (laminectomy only),
- Sham-SW Group (low-energy ESWT after laminectomy),
- SCI Group (SCI only), y
- SCI-SW group (low-power ESWT applied after SCI).
Thoracic spinal cord contusion was inflicted with an impactor. Low-energy ESWT was applied to the injured spinal cord three times a week for 3 weeks. Motor function was assessed using the Basso, Beattie, and Bresnahan (BBB) scale (open field locomotor score) at various time points during 42 days after SCI. Hematoxylin and eosin staining was performed to assess nerve tissue damage in the spinal cord. Neuronal loss was assessed by immunostaining for NeuN. Expressions of VEGF mRNA and its receptor, Flt-1, in the spinal cord were assessed by real-time polymerase chain reaction. Immunostaining for VEGF was performed to assess VEGF protein expression in the spinal cord. In the sham and sham SW groups, no animal showed locomotor impairment in the BBB score. Histological analysis of H&E and NeuN staining in the sham SW group confirmed that low-energy ESWT does not induce neural tissue damage. It is important to emphasize that the animals in the SCI-SW group showed significantly better locomotor improvement than those in the SCI group at 7, 35 and 42 days after the injury (p<0.05). The number of NeuN-positive cells in the SCI-SW group was significantly higher than in the SCI group 42 days after injury (p<0.05). Furthermore, VEGF and Flt-1 mRNA expressions were significantly increased in the SCI-SW group compared to the SCI group at 7 days post-injury (p<0.05). VEGF protein expression in the SCI-SW group was significantly higher than in the SCI group after 7 days (p<0.01). The authors concluded that the present study demonstrated that low-energy ESWT significantly increased VEGF and Flt-1 expression in the spinal cord without adverse effects. Furthermore, it significantly reduced neuronal loss in damaged neural tissue and improved motor function after spinal cord injury. These results suggested that low-energy ESWT enhances the neuroprotective effect of VEGF in reducing secondary injury and leads to better musculoskeletal recovery after spinal cord injury. They stated that the results of this study provided the first evidence that low-energy ESWT could be a safe and promising therapeutic strategy for SCI.
Yu et al. (2015) evaluated the effectiveness of passive physical modalities for the treatment of shoulder soft tissue injuries. We searched MEDLINE, EMBASE, CINAHL, PsycINFO and the Cochrane Central Register of Controlled Trials from January 1, 1990 to April 18, 2013. Randomized controlled trials, cohort and case-control studies were eligible. Randomized pairs of independent reviewers reviewed 1470 of the 1760 articles found, after removing 290 duplicates. A total of 22 articles could be critically evaluated. Eligible studies were critically appraised using Scottish Intercollegiate Guidelines Network criteria. Of these, 11 studies had a low risk of bias. The lead author extracted data from low-risk studies and produced tables of evidence. A second reviewer independently reviewed the extracted data. Results from studies with low risk of bias were synthesized using best evidence synthesis principles. Tension tape, ultrasound, and interferential current were ineffective in controlling shoulder pain. However, diathermy and corticosteroid injections produced similar results. Low-level laser therapy resulted in short-term pain relief in subacromial impingement syndrome. Extracorporeal shock wave therapy was not effective in subacromial impingement syndrome but was beneficial in persistent calcific tendonitis of the shoulder. The authors concluded that patients with subacromial impingement syndrome do not benefit from most passive physical modalities. However, low-level laser therapy is more effective than placebo or ultrasound for subacromial impingement syndrome. Likewise, ESWT is more effective than sham therapy for persistent calcareous tendonitis of the shoulder.
The American Urological Association's "Peyronie's disease" guideline (Nehra et al., 2015) states that "clinicians should not use extracorporeal shock wave therapy (ESWT) to reduce penile curvature or penile size."
Slikkerveer et al (2016) noted that patients with refractory angina are constantly looking for new treatment options to improve quality of life. Several studies have recently shown promising results from angiogenesis stimulation using ESWT in these patients. These investigators quantitatively analyzed the effect of ESWT on myocardial perfusion in patients with refractory angina. They included 15 patients with New York Heart Association (NYHA) class 3 to 4, of whom 8 patients underwent cardiac magnetic resonance imaging (CMR) at baseline and follow-up. All patients received 9 ESWT sessions of their ischemic area over a 3-month period. Quantitative analysis of myocardial perfusion by CMMR showed no significant improvement in myocardial perfusion after treatment (0.80 ± 0.22 vs. 0.76 ± 0.31; p = 0.42). However, the overall group of 15 patients experienced a significant improvement in NYHA class (p=0.034) and a reduction in nitroglycerin consumption (p=0.012). The authors concluded that although ESWT was associated with improvement in the NYHA class, they did not observe improvement in the myocardial ischemic zone and perfusion with RMRC. They stated that further in vitro and animal studies, as well as larger (placebo-controlled) studies are needed to elucidate the exact mechanisms of ESWT.
Lymphedema related to breast cancer
In a pilot study, Cebicci and colleagues (2016) examined the clinical effect of ESWT in patients with secondary lymphedema after breast cancer treatment. Women diagnosed with lymphedema due to breast cancer (n = 11) were treated with 12 ESWT sessions of 2,500 pulses each. The treatment frequency was 4 Hz in the multiple discharge mode. The energy flux density during the treatment was equal to a working pressure of 2 bar. The primary outcome measure was volumetric measurements; secondary outcomes were the short version of the Hand, Shoulder and Arm Disability Questionnaire (QuickDASH) and the short version of the World Health Organization Quality of Life Questionnaire (WHOQOL-BREF). Assessments were performed by the same investigator at baseline, post-treatment, and 1, 3, and 6 months after treatment for all patients. A significant reduction in lymphedema was seen in all patients with ESWT treatment and this reduction lasted for 6 months. There was a statistically significant reduction in volume measurements during the follow-up period (p=0.001). The mean volume displacement of the affected upper limb before treatment was 870.45 ± 384.19 ml at 6 months and 604.54 ± 381.74 ml after treatment. Improvements were also observed in the QuickDASH functional assessment tool and in the physical health area of the WHOQOL -BREF questionnaire (p=0.002 and p=0.007, respectively). The authors concluded that ESWT has been shown to reduce the amount of lymphedema in patients with lymphedema secondary to breast cancer. In addition, a significant improvement in the functional status and quality of life of the study patients was observed. The effectiveness of the treatment was maintained in the long term. They found that ESWT, as a non-invasive and innovative method, is a promising treatment modality for the management of lymphedema, which is a chronic, progressive and refractory disease. These preliminary results need to be validated by well-designed studies.
In a meta-analysis, Knobloch and Kraemer (2015) examined the effectiveness of ESWT for cellulite. Electronic databases (such as Ovid Medline, Scopus and Ovid) and reference lists of available studies were reviewed by 2 reviewers in June 2015. The methodological quality of each study was assessed using the Quality Index tool published by Downs and Black. This meta-analysis included a total of 11 clinical studies on the effects of ESWT on cellulite with a total of 297 women included. Of the 11 clinical trials, 5 RCTs on ESWT for cellulite have been published to date, involving a total of 123 women. Focused ESWT and Radial ESWT (RESWT) devices have been shown to be effective in the treatment of cellulite. Typically 1-2 sessions per week and 6-8 sessions in total have been studied in published clinical studies. In general, outcome parameters were primarily focused on standardized digital photos, circumference measurements, and specific ultrasound scans. The quality of the report showed significant heterogeneity from 22 to 82 points with an average of 57 points. The authors concluded that this meta-analysis identified 11 published clinical trials on ESWT for cellulite, including 5 RCTs. There is growing evidence that both RESWT and focused ESWT, and the combination of both, can improve cellulite levels. Typically 6 to 8 treatments were studied once or twice a week. Furthermore, they stated that they lack long-term follow-up data beyond 1 year, as well as details on possible combination therapies for cellulite, such as: B. Low-level laser therapy, cryolipolysis, and others.
Chronic pelvic pain/chronic prostatitis
Fojecki and colleagues (2017) reviewed high-level evidence studies on ESWT in urological diseases. These investigators included RCTs reporting ESBT outcomes in urology. A literature search for English language studies was performed using Embase, Medline, and PubMed. The systematic review was performed according to PRISMA guidelines. They identified 10 studies in 3 urologic indications; 2 of 3 Peyronie's disease (PD) studies involving 238 patients reported improvement in pain; however, no clinically significant changes in penile deviation or plaque size were observed; Four erectile dysfunction (ED) studies with 337 participants were included. Using data from the International Index of Erectile Function (IIEF-EF) and the Erectile Hardness Scale (EHS) indicated a significant beneficial effect of ESWT on phosphodiesterase 5 inhibitor (PDE-5i) responders in 2 of 4 studies, respectively. 3 of 4 studies; 3 chronic pelvic pain (CPP) studies involving 200 men reported positive changes on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). There was considerable heterogeneity between studies in terms of treatment techniques and outcome measures, making it difficult to compare results. The authors concluded that ESWT can reduce pain in patients with PD, while evidence of reduction in curvature and plaque size is scarce. The effects of ESBT on IIEF in patients with erectile dysfunction are conflicting; however, the EHS data suggest that treatment can potentially restore natural erections in PDE-5i responders; ESWT appears to be able to provide short-term pain relief in patients with CPP. They indicated that all 3 disease entities needed long-term outcome data.
In a systematic review and meta-analysis, Yuan and colleagues (2019) examined the effectiveness of low-intensity ESWT (Li-ESWT) for the treatment of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). These investigators performed a comprehensive search in Medline, Web of Science, Embase, and the Cochrane Library through January 6, 2019 for RCTs reporting patients with CP/CPPS treated with Li-ESWT compared to the sham group. Results were evaluated according to the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). The quality assessment of the included studies was performed using the Cochrane system. A total of 6 publications were evaluated in this review, including 5 RCTs with 280 patients. NIH-CPSI total score, pain domain, and quality of life were significantly better in the Li-ESWT group at endpoint (p<0.00001, p=0.003, and p<0.00001), 4 weeks (p< 0.00001) than in the control group, p=0.0002 and p<0.00001) and 12 weeks (p<0.00001, p<0.00001 and p=0.0002) after treatment. There was a significant difference for the urine score 12 weeks after treatment (p = 0.006). 24 weeks after treatment, there were no significant differences between the two groups in NIH-CPSI total score (p = 0.26), area of pain (p = 0.32), urine score (p = 0, 07) and quality of life (p = 0.29). The authors concluded that Li-ESWT showed high efficacy for the treatment of CP/CPPS at the end and during the 4-week and 12-week follow-up, although the efficacy at the 24-week follow-up was rated as "inadequate". significantly different. These researchers found that Li-ESWT is a promising minimally invasive method to treat CP/CPPS.
In a systematic review, Li and Man (2021) examined the effectiveness of low-intensity ESWT (LI-ESWT) in patients with chronic pelvic pain syndrome (CPPS). These investigators performed a comprehensive search of the Cochrane Register, PubMed, and Embase databases for controlled trials evaluating patients with CPPS treated with LI-ESWT that were published before August 2019. The Prostatitis Symptom Index The Chronic Prostatitis Symptom Index of the National Institutes of Health (NIH-CPSI) was the most commonly used tool to assess the effectiveness of LI-ESWT treatment. The NIH-CPSI includes subscales for pain [using a VAS], urinary function, and quality of life (QOL). A total of 6 studies were published between 2009 and 2019, in which 317 patients were analyzed. Overall meta-analysis of the data showed that LI-ESWT showed efficacy in the treatment of PCPS at 12 weeks [risk difference (RD): 0.46; 95% CI 0.28 to 0.63; p<0.00001]. Studies were divided into 3 groups based on time after LI-ESWT (1, 12, and 24 weeks) and compared for NIH-CPSI total scores, QOL, VAS scores, and urinary symptoms. NIH-CPSI total scores, quality of life, VAS scores, and urinary symptom scores improved significantly at 12 weeks after LI-ESWT (p<0.05), but not at week 1 or week 1, 24 (p>0.05). The authors concluded that, based on these studies, LI-ESWT may temporarily improve NIH-CPSI total scores, quality of life, pain scores, and urinary symptom scores in patients with PCPS. Furthermore, these investigators indicated that future research could elucidate the mechanisms underlying the effects of LI-ESWT on CPPS. They stated that multicenter, well-designed, long-term RCTs are needed to investigate the real potential and usefulness of these devices in patients with CPPS.
The authors stated that this study had several drawbacks. First, sample sizes in most studies were small; the largest sample size in this meta-analysis included only 80 male patients. Team blinding did not occur in most RCTs. Second, regarding patient demography, few studies have described prior selection criteria and treatment strategies. Third, the short-term follow-up of the included studies. Follow-up was limited to approximately 12 weeks in most studies; Therefore, the robustness of this approach is unknown and long-term data are needed. The 6 studies in this meta-analysis included 5 RCTs and one non-randomized controlled trial. No placebo response was seen in the sham arm, which was unusual. Previously treated men were also included in some studies. If there was any bias, it would significantly affect the interpretation of the results of this meta-analysis. Fourth, this study had a very high degree of heterogeneity (I2 = 71%). Possible reasons for this heterogeneity could be the selection of participants and the therapeutic regimen. One study used 3,000 treatment puffs over 12 weeks, another study used 2,000 treatment puffs over 10 weeks, while other studies used 3,000 treatment puffs over 4 weeks.
Different configuration parameters and different treatment protocols for LI-ESWT have a significant impact on therapeutic efficacy. The clinical outcome of the LI-ESWT is closely related to the energy delivered to the Target Area Unit or EFD. EFDs used in the included studies ranged from 0.05 to 0.25 mJ/mm2. Based on this review, we were unable to determine the best EFD for CPPS therapy. Most of the included studies used an EFD of 0.25 mJ/mm2, which Zimmermann et al. first reported in 2009 (8). Most subsequent studies adopted this EFD and showed encouraging results. Additional studies and longer duration of treatment are needed to determine whether therapeutic efficacy is positively correlated with energy density.
Future LI-ESWT research should be based on basic research and clinical studies. Extensive basic research is required to understand LI-ESWT's mechanism of action. Several devices with a source of radial or focused shock waves are available on the market, such as electrohydraulic, electromagnetic and piezoelectric generators, and each type of device uses a different treatment protocol. More studies are needed to evaluate the different devices and protocols. Well-designed, long-term, multi-center RCTs are urgently needed to assess the true potential and end-use benefits of these devices in patients with CPPS.
Ryu et al. (2016) reported the effects of RESWT on heterotopic ossification (HO). Two cases of neurogenic HO in the upper extremity underwent ultrasound-guided RESWT using the MASTER PLUS MP 2000 (Storz, Tägerwilen, Switzerland) (USA). The ERSWT protocol consisted of 3000 pulses at a frequency of 12 Hz during each treatment. The intensity level varied from 2 to 5 bars and was administered 5 times a week for 4 weeks, totaling 20 treatments; RESWT improved pain, range of motion, and hand function in 2 patients with neurogenic upper extremity HO. The authors concluded that further studies are needed to substantiate these findings and understand the mechanism and design the RESWT protocol for neurogenic HO.
Caron et al. (2016) investigated whether ESWT could enhance renal repair and promote angiogenesis in L-NAME-induced hypertensive nephropathy in rats; TOCH was initiated when proteinuria exceeded 1 g/mmol of creatinine and 1 week after L-NAME removal; ESWT consisted of triggering 0.09 mJ/mm(2) (400 shots) three times a week. After 4 weeks of SWT, blood pressure, renal function and urinary protein excretion did not differ between treated (LN + SWT) and untreated (LN) rats. Histological lesions, including glomerulosclerosis and arteriolosclerosis scores, tubular dilation, and interstitial fibrosis, were similar in both groups. Furthermore, peritubular capillaries and eNOS, VEGF, VEGF-R and SDF-1 gene expression were not increased in ESWT-treated animals compared to untreated animals. No procedure-related complications or side effects were observed in control rats (C + ESWT) and hypertensive rats (LN + ESWT). The authors concluded that these findings suggest that ESWT does not induce angiogenesis and does not improve renal function and structure, at least in the model of hypertensive nephropathy, although the treatment was well tolerated.
Spasticity after stroke
Li and colleagues (2016) noted that recent studies have reported that ESWT is a safe, non-invasive alternative treatment for spasticity. However, the effect of ESWT on spasticity cannot be determined because most studies to date have only enrolled small numbers of patients and lack placebo-controlled groups and/or long-term follow-up. Furthermore, no studies have examined whether varying the number of ESWT sessions affects the duration of therapeutic effect. These investigators conducted a prospective, randomized, single-blind, placebo-controlled study to investigate the long-term effects of RESWT in patients with post-stroke spasticity and examined functional activity outcome. A total of 60 patients were randomized into 3 groups:
- Group A patients received 1 session of RESWT per week for 3 consecutive weeks;
- Patients in group B received a single session of RESWT; Y
- Patients in Group C received 1 simulated session of RESWT per week for 3 consecutive weeks.
The primary outcome measure was the modified Ashworth hand and wrist scale, while the secondary outcomes were the Fugl-Meyer assessment of hand function and wrist control. Assessments were performed prior to the first RESWT treatment and immediately at 1, 4, 8, 12, and 16 weeks after the last RESWT session. Compared with the control group, the significant reduction in hand and wrist spasticity in groups A and B lasted at least 16 and 8 weeks, respectively; 3 RESWT sessions had a longer lasting effect than 1 session. Furthermore, the reduction in spasticity after 3 RESWT sessions may be beneficial for hand function and wrist control, and the effects lasted for 16 and 12 weeks, respectively. The authors concluded that RESWT may be beneficial in reducing hand and wrist spasticity with improved wrist control and hand function in patients with chronic stroke. These preliminary results need to be validated by well-designed studies.
In a systematic review and meta-analysis, Xiang and colleagues (2018) investigated whether ESWT significantly improves spasticity in post-stroke patients. Data sources included PubMed, Embase, EBSCO, Web of Science, Cochrane CENTRAL electronic databases; RCTs examining the effect of ESWT in people with post-stroke spasticity were selected for inclusion. Two authors independently reviewed the literature, extracted data, and assessed the quality of included studies. The primary endpoint was MAS; secondary endpoints were modified Tardieu scale (MTS), H/M ratio (ratio of maximum H-reflex amplitude to maximum M wave), and range of motion (ROM). A total of 8 RCTs (n = 385 patients) were included in the meta-analysis. There was a high level of evidence that ESWT significantly improved spasticity in stroke patients on all 4 parameters: MAS (SMD -1.22, 95% CI -1.77 to -0.66); MTS (SMD 0.70, 95% CI 0.42 to 0.99); M/F ratio (weighted MD (WMD) -0.76, 95% CI -1.19 to -0.33); ROM (SMD 0.69, 95% CI 0.06 to 1.32). However, there was no statistically significant difference in MAS at 4 weeks (SMD -1.73, 95% CI -3.99 to 0.54). The authors concluded that the results of this meta-analysis showed that ESWT was effective in improving spasticity in patients who had suffered a stroke. However, due to the heterogeneity and small sample size in this study, these results need further confirmation in larger multicenter RCTs. These investigators indicated that further research should also focus on optimal stimulation parameters in ESWT in order to develop effective treatment strategies for spasticity in post-stroke patients.
The authors stated that this study had several drawbacks. First, significant heterogeneity was observed in the meta-analysis. Second, the total number of RCTs and the total number of subjects tested were relatively small. Third, relevant data were limited to assessing the long-term outcomes of ESWT in the acute and chronic treatment of spasticity in patients who have experienced a stroke. Fourth, the measurement of spasticity based on MAS and MTS was insufficient, and another evaluation method such as B.F/M ratio is needed. Finally, only studies published in English were included, which may have introduced bias. Because of these drawbacks, future ESWT clinical trials should focus on examining larger, more representative RCTs; include a sufficient number of stroke patients with spasticity; Determine the optimal protocol for ESWT to ensure it is most efficient in the short and long term.
Subacromial shoulder pain
Kvalvaag et al. (2015) found that subacromial shoulder pain is a common complaint; The RESWT is increasingly used to treat both calcific and non-calcific tendinosis, although there is no evidence that the RESWT is effective in non-calcific tendinosis of the rotator cuff. A random one. The single-blind study showed that the short-term effect of supervised exercise (SE) on subacromial shoulder pain was significantly better than RESWT, but both groups improved. In a clinical study of Achilles tendinopathy, RESWT improved the effectiveness of eccentric loading treatment. These investigators investigated whether RESWT, in addition to SE, is more effective than simulated RESWT and SE in improving shoulder pain and function in patients with subacromial shoulder pain. This is a double-blind, randomized, simulation-controlled study being conducted at the Shoulder Clinic, Department of Physical Medicine and Rehabilitation, University Hospital Oslo, Norway. A total of 144 patients with subacromial shoulder pain lasting at least 3 months, aged between 25 and 70 years, were included in the study. Patients will be randomized in a 1:1 ratio to receive RESWT or sham RESWT once weekly in addition to SE once weekly for the first 4 weeks. SE will then be offered twice a week for 8 weeks. The primary outcome measure is a change in the Shoulder Pain and Disability Index (SPADI) at 24-week follow-up; secondary outcomes include return to work, pain at rest and during activity, function, and health-related quality of life. Patients, the physiotherapist providing the exercise program, and the outcome assessor are unaware of group allocation. The physiotherapist who performs the RESWT is not blind. The authors concluded that, due to the widespread use of RESWT in the treatment of subacromial shoulder pain, the results of this study will be important and will have an impact on clinical practice.
In an RCT, Kvalvaag and colleagues (2017) investigated whether rESWT is more effective than sham rESWT when combined with supervised exercise to improve pain and function in patients with subacromial shoulder pain. Eligibility was assessed in patients aged 25 to 70 years with subacromial shoulder pain with and without rotator cuff calcification of at least 3 months' duration; 143 patients were recruited. Participants were randomized (1:1) by computer-generated randomization in blocks of 20 to receive either rESWT or simulated rESWT plus supervised exercise. rESWT and simulated rESWT were performed once a week with additional supervised exercise once a week for the first 4 weeks. For the next 8 weeks, subjects received supervised exercise twice a week. The primary endpoint was change in SPADI at 24 weeks. Patients and outcome assessors were blinded to group assignment. At 24 weeks, participants in the sham and rESWT groups improved their SPADI score compared to baseline (p<0.001) (-23.9 points [SD, 23.8 points] and -23.3 points [SD, 25.0 points]), but there was no difference between groups (MD 0.7, 95% CI -6.9 to 8.3, P=0.76). Analysis of predefined subgroups of patients with rotator cuff calcification showed that the rESWT group had a greater improvement in the SPADI score at 24 weeks (MD -12.8, 95% CI -24.8 to -0.8, p=0.018 ). The authors conclude that rESWT at 24 weeks offered no additional benefit over supervised exercise in the management of subacromial shoulder pain, except in the subgroup of patients with rotator cuff calcification.
Vardi and colleagues (2012) evaluated the clinical and physiological effects of low-intensity ESWT in men with organic erectile dysfunction who responded to phosphodiesterase type 5.1 inhibitors to receive 12 sessions of low-intensity ESWT or sham therapy. Erectile function and penile hemodynamics were assessed before initial treatment (Visit 1) and 1 month after final treatment (Follow-up 1) using validated sexual function questionnaires and veno-occlusive plethysmography with strain gauges. Clinically, these investigators found a significantly greater increase in the International Index of Erectile Function Erectile Function Area score from Visit 1 to Follow-up 1 in the treated group than in the placebo-treated group (mean +/- SEM 6.7 +/- 0.9 vs 3.0 +/-1.4, p=0.0322). There were 19 men in the treatment group who were initially unable to obtain erections strong enough for penetration (erection hardness score of 2 or less) but were able to obtain erections firm enough for penetration (erection hardness score of 3 or more) after a low-intensity ESWT. , compared to none in the sham group. The physiological hemodynamics of the penis improved significantly in the treated group, but not in the sham group (post-ischemic peak penile blood flow 8.2 vs. 0.1 ml/min/dL, p<0.0001). None of the men had symptoms or reported side effects from the treatment. The authors concluded that, to our knowledge, this is the first randomized, double-blind, simulation-controlled study demonstrating that low-intensity ESWT has a positive short-term clinical and physiological effect on erectile function in men who are dependent on an oral sex phosphodiesterase-responsive type 5. Therapy. The feasibility and tolerability of this treatment, along with its potential rehabilitative properties, make it an attractive new therapeutic option for men with erectile dysfunction. They indicated that additional studies with long-term follow-up are needed to evaluate the effectiveness of this new therapy and confirm these results.
Zou and colleagues (2017) stated that the role of low-intensity ESWT (LI-ESWT) in erectile dysfunction is not clearly determined. In a systematic review and meta-analysis, these investigators examined the short-term safety and efficacy of LI-ESWT in patients with erectile dysfunction. Medline, Embase, Cochrane Library, China National Knowledge Infrastructure (CNKI), WANFANG, and VIP databases were searched for relevant studies. Effective rate in terms of the International Index of Erectile Function-Erectile Function Domain (IIEF-EF) and Erectile Hardness Score (EHS) approximately 1 month after LI-ESWT was extracted from studies eligible for meta-analysis calculating risk ratio ( RR) came into question. of effective treatment in ED patients treated with LI-ESWT compared to those who received sham treatment. A total of 15 studies were included in the review, 4 of which were RCTs for the meta-analysis. Effective treatment was 8.31 times [95% CI 3.88 to 17.78] times more effective in the LI-ESWT group (n = 176) with respect to EHS than in the LI-ESWT group at approximately 1 month post-treatment. simulated group intervention (n=101). was 2.50 (95% CI: 0.74 to 8.45) times more in the treatment group (n=121) than in the control group (n=89) in terms of IIEF-EF. They reported that the 9-week protocol using an energy density of 0.09 mJ/mm2 and more than 1500 seems to have a better therapeutic effect than the 5-week protocol. No significant adverse events (AEs) were reported. The authors concluded that LI-ESWT as a non-invasive treatment has a potential short-term therapeutic effect in patients with organic erectile dysfunction, regardless of PDE5is sensitivity. However, they indicated that, due to the limited number and quality of the studies, large, well-designed, long-term follow-up studies are needed to confirm the results of this meta-analysis.
In a systematic review and meta-analysis, Man and Li (2018) examined the effectiveness of Li-ESWT on erectile dysfunction. A comprehensive search of PubMed, Cochrane Register, and Embase databases for RCTs reporting patients with erectile dysfunction treated with Li-ESWT was performed through March 2017. IIEF and EHS were the most commonly used tools to assess the therapeutic efficacy of Li-ESWT. ESWT. There were 9 studies involving 637 patients between 2005 and 2017. A meta-analysis found that Lys ESWT IIEF (MD 2.54, 95% CI 0.83 to 4.25, p = 0.004) and EHS (risk difference [RD] : 0.16, 95 ) could significantly improve %CI: 0.03 to 0.28; p = 0.01). Therapeutic efficacy can last for at least 3 months (MD: 4.15; 95% CI: 1.40 to 6.90; p = 0.003). The lowest energy density (0.09 mJ/mm2, MD: 4.14; 95% CI: 0.87 to 7.42; p = 0.01) increased the number of pulses (3000 pulses per treatment, MD: 5, 11, 95% CI 3.18 to 7.05, p<0.0001). ) and shorter overall treatment cycles (less than 6 weeks, DM 3.73, 95% CI 0.54 to 6.93; p = 0.02) resulted in better therapeutic efficacy. The authors concluded that these results suggest that Li-ESWT can significantly improve IIEF and EHS in patients with erectile dysfunction. Furthermore, these investigators stated that the publication of additional RCT evidence and a longer-term follow-up would provide more confidence in the use of Li-ESWT in patients with erectile dysfunction.
Rizk and colleagues (2018) examined the effectiveness of Li-ESWT for the treatment of erectile dysfunction. These investigators reviewed published literature, including RCTs, meta-analyses, and selected single-arm studies, on the use of Li-ESWT to treat erectile dysfunction. Changes in IIEF scores were evaluated in patients undergoing Li-ESWT. There was no consensus from the RCTs on the effectiveness of Li-ESWT in the treatment of erectile dysfunction. Published meta-analyses have shown a significant improvement in IIEF-EF domain scores in men undergoing Li-ESWT, particularly when compared to men receiving sham treatment. However, differences in treatment protocols limited the generalizability of these results. Li-ESWT may be more beneficial in mild ED or in combination with PDe-5i in men with moderate to severe ED. The role of Li-ESWT in the treatment of non-vasculogenic erectile dysfunction is still poorly defined. The authors concluded that Li-ESWT may be beneficial in certain subgroups of men with vasculogenic erectile dysfunction. However, they indicated that future RCTs should try to optimize treatment protocols and have stricter inclusion criteria to confirm these findings.
Campbell et al. (2019) performed a meta-analysis of RCTs examining the effectiveness of Li-ESWT for the treatment of erectile dysfunction. These investigators performed a comprehensive search of PubMed, Medline, and Cochrane databases from November 2005 to July 2018; RCTs that evaluated the effectiveness of Li-ESWT in the treatment of erectile dysfunction were selected. The primary endpoints were DM between treatment and sham patients in the IIEF-EF domain score 1 month after treatment and the mean change in IIEF-EF from baseline to 1 month after treatment. Secondary analysis examined the percentage of men whose EHS changed from less than 2 at baseline to more than 3 after treatment. All analyzes used a random effects method to pool specific study results. A total of 7 RCTs provided data for 607 patients. Mean IIEF-EF 1 month after treatment ranged from 12.8 to 22.0 in the treatment group versus 8.17 to 16.43 in the sham group. The MD between treatment and sham groups at 1-month follow-up was a statistically significant increase in IIEF-EF of 4.23 (p = 0.012). Overall, 5 of the 7 studies provided data on the proportion of patients with baseline EHS less than 2 who improved to EHS more than 31 months after treatment. The proportions ranged from 3.5 to 90% in the treatment group versus 0 to 9% in the sham group, and the pooled relative risk of EHS improvement for the treated versus sham group was 6.63 (p=0, 0095). No significant adverse events were reported. The authors concluded that this was the first meta-analysis examining RCTs examining Li-SWOT as a therapeutic modality exclusively for erectile dysfunction. These investigators stated that this therapeutic strategy appeared to be well tolerated and had short-term benefits; However, more studies are needed to investigate specific regimens and long-term outcomes.
Brunckhorst and colleagues (2019) reviewed the evidence base for Li-ESWT as a treatment modality for vasculogenic erectile dysfunction, with a focus on long-term outcomes beyond 6 months after treatment. These researchers performed a systematic literature search using Medline and Scopus databases from 2010 to September 2018 by 2 independent reviewers. Results extracted for long-term efficacy included IIEF and EHS scores. Subgroup analysis of Li-ESWT efficacy included age, PDE-5i responsiveness, presence of vascular comorbidities, and smoking. The search identified 11 studies involving a total of 799 patients; 9 studies found a significant improvement in erectile function after Li-ESWT at 6 months follow-up (median IIEF-EF improvement 5.3 at 6 months). However, from 5 studies that assessed erectile function at 12 months; 2 observed stabilization of results, 3 worsening (changes in IIEF-EF score from -2 to 0.1 after 6 months). However, erectile function remained above baseline in all these studies. Subgroup analysis revealed an increase in age to reduce response to Li-ESWT treatment. Although the severity of erectile dysfunction, PDE-5i response and comorbidities may have affected efficacy, results were still inconsistent. The authors concluded that Li-ESWT may be a potentially safe and acceptable treatment for erectile dysfunction with proven benefit at 6 months. There are concerns about worsening effectiveness beyond this, but proven benefit can still be seen 12 months after treatment. However, these investigators stated that the quality of the evidence remains low and larger multi-institutional studies are needed in which confounders such as shockwave administration and oral medication use are standardized.
Ladegaard and colleagues (2021) noted that previous studies have indicated that LI-ESWT can improve male erectile dysfunction of vascular etiology. In a prospective, randomized, placebo-controlled study, these investigators evaluated penile rehabilitation with LI-ESWT in men with erectile dysfunction after nerve-sparing robotic radical prostatectomy (RARP). Men with erectile dysfunction after nerve-sparing RP who scored less than 22 on the 5-item IIEF questionnaire (IIEF-5) were included. Subjects were divided into an active group A (n=20) and a placebo/sham B group (n=18). They were consecutively randomized at study entry. Each study arm received 1 treatment per week for 5 weeks. Sexual outcomes were assessed using internationally validated questionnaires, EHS and IIEF-5 at baseline and 4 and 12 weeks after treatment. A total of 38 (n=38) subjects were enrolled; there were no dropouts. A significant increase in IIEF-5 and EHS was observed in group A at 4 and 12 weeks. At 12 weeks, the mean IIEF-5 score increased by 3.45 points (p=0.026), while the mean EHS score increased by 0.5 points (p=0.019). The authors concluded that the results of this randomized trial demonstrated that LI-ESWT can be safe and effective for erectile dysfunction in men undergoing RP; However, these investigators indicated that more robust research is needed before LI-ESWT can be characterized as a reliable treatment modality.
The authors stated that this study had several drawbacks. First, these investigators did not prohibit the use of erectogenic aids (EAs) currently in use. Other studies conducted drug-free settings with good results and still had low dropout rates, ensuring parameters were comparable across cohorts. These investigators were fully aware that there could be differences between patients when using 5-phosphodiesterase inhibitors (5-PDEI), but the same bias existed in both groups. Second, this study had a small number of subjects. In the protocol, these investigators stated that they intended to recruit 70 subjects. Assuming a dropout rate of 7%, similar to what previous studies found, these investigators would have wanted 32 subjects in each treatment arm. They performed an interim analysis with the available results and decided to stop recruiting, reaching a total of 38 individuals. Surprisingly, 76% of subjects had severe ED at baseline (based on the IIEF-5 score), whereas the proportion of subjects with severe ED at baseline by Frey et al. (2016) was 31%. This difference likely arose because the subjects in this study were recruited from a sex clinic, where referred patients are likely to have worse ED than the average PR patient. Preoperative ED was assessed using patient reports. The patient's statement was compared with medication prescription history where previous use of 5-PDEI or other AE was not accepted. Possibly, individuals may be confused regarding their preoperative ED function. However, it was evident that RP had a major impact on their erectile function when they sought help at the authors' clinic.
Kalka et al. (2021) found that more than 50% of older men and 70% of male heart patients suffer from erectile dysfunction. While drug therapy is effective and safe, it only provides short-term relief and can cause side effects. Low-Energy SWT (LESWT) is a promising causal modality for the treatment of erectile dysfunction. Evidence is still limited as different devices produced different results. In a systematic review, these investigators examined evidence from RCTs on the effectiveness of LESWT generated by an electrohydraulic unit for the treatment of erectile dysfunction. They performed a PubMed literature search on May 20, 2018, and the search was complemented by a Google search of gray literature and a hand search of the bibliographies of the articles found. Of the 34 studies, 5 studies with 354 patients were included in the quantitative synthesis. Studies have evaluated an abbreviated IIEF-5, the EHS, and flow-mediated dilation (FMD). Meta-analysis revealed that LESWT reduced the IIEF-5 score (MD: 5.16, 95% CI: 1.39 to 8.93, p=0.0073) and the EHS score (risk difference [RD] : 0.72, 95% CI 0.73 to 0.80, p<0.001). The FMD report was inconsistent and was not analysed. Meta-analyses of studies performed with electro-hydraulic devices showed greater benefit for patients compared to meta-analyses of heterogeneous studies performed with different shockwave generating devices. The authors concluded that there is evidence that LESWT generated with an electro-hydraulic unit was effective. Furthermore, these researchers stated that more research is needed to investigate this method in different patient populations and its long-term effectiveness.
Wound healing/burn treatment
Omar and colleagues (2017) provided an updated review of the effectiveness of ESWT in chronic lower limb wound healing (CWLE). These researchers performed a systematic review of 10 databases of clinical trials of ESWT in the treatment of CWLE published between 2000 and 2016. They found a total of 11 studies involving 925 patients. Experienced therapists assessed the methodological qualities of the selected studies using the Physiotherapy Evidence Database (PEDro) scale and ranked each study according to Sackett's level of evidence; 8 studies were categorized as Level II; 2 studies were classified as Level III and 1 study as Level V. The authors concluded that the results of this review showed little to moderate evidence to support the use of ESWT as an adjunct therapy to a standardized wound care program. However, they indicated that it was difficult to draw firm conclusions about ESWT's effectiveness; Therefore, further studies of high methodological quality are needed to investigate the efficacy and cost-effectiveness of this relatively new application of physiotherapy.
In a systematic review and meta-analysis, Zhang and colleagues (2018) examined the effects of ESWT and conventional wound therapy (CWT) on acute and chronic soft tissue wounds. All articles in English on ESWT for acute and chronic soft tissue wounds published before June 2017 and indexed in PubMed, Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Library, Physiotherapy Evidence Database and HealthSTAR were included. Articles cited in reference lists of related review articles. The methodological quality of selected studies was assessed using the Cochrane Collaboration's "Risk of Bias" tool. Study design, patient demographics, wound etiology, treatment protocols, scoring indices, and duration of follow-up were extracted. Fixed or random effects model was used to calculate pooled effect sizes based on study heterogeneity. A total of 10 RCTs with 473 patients were included in this systematic review and meta-analysis. Meta-analysis showed that ESWT statistically significantly increased the healing rate of acute and chronic soft tissue wounds by 2.73-fold (OR = 3.73, 95% CI 2.30 to 6.04, p < 0.001) and the percentage of wound healing area improved by 30.45%. (SMD = 30.45; 95% CI: 23.79 to 37.12; p<0.001). ESWT reduced wound healing time by 3 days (SMD = -2.86, 95% CI: -3.78 to -1.95, p < 0.001) in acute soft tissue wounds and by 19 days (SMD = -19.11, 95% CI: -23.74 to -14.47, p<0.001) for chronic soft tissue wounds and the risk of wound infection was 53% (OR=0.47, 95% CI %: 0.24 to 0.92, p=0.03) compared to CWT alone. No serious side effects have been reported. The authors concluded that TOCH showed better therapeutic effects in acute and chronic soft tissue wounds compared to OCD alone. However, these investigators indicated that well-controlled, high-quality RCTs are needed to better assess the role of ESWT in acute and chronic soft tissue wounds.
Aguilera-Saez et al. (2020) noted that ESWT, first described in the 1980s for the treatment of urolithiasis, has also been used in other areas such as orthopedics and the treatment of chronic wounds. Recently, it has also been used to treat burns and their consequences, as several studies indicate that it can be an important tool in the conservative management of these conditions. These investigators reviewed the literature for published evidence supporting the use of ESWT to treat patients with acute burns and their sequelae and provided a brief update on the subject. They searched the PubMed database and the Cochrane database using the following terms: ("burns" [title/abstract] OR "burns" [title/abstract]) AND "shock wave" ([title/abstract] ). For optimized reporting of the studies found, these investigators followed the PRISMA statement. This search found 34 articles, of which only 15 were actually related to the use of ESWT in burn patients. Of these 15 articles, 7 deal with the use of ESWT in the treatment of acute burns, 6 with its use on burn scars, 1 with the treatment of heterotopic ossification, and 1 with the use of ESWT at the donor site. of skin grafts. 🇧🇷 With the exception of the last one, all have been carefully checked. The authors concluded that the evidence for the use of ESWT to treat burn patients is weak due to the scarcity of studies and their low quality. However, TOCH appears to be a promising tool in this area; therefore, more high-quality studies should be conducted.
Haghighat and Mashayekhi (2016) noted that several surgical and non-surgical treatment modalities are available for patients with chronic coccyx disease, with controversial results. In a quasi-interventional clinical trial, these investigators investigated the effects of ESWT on pain in patients with chronic coccyx disease. This study included 10 patients with chronic coccygodynia without an acute fracture. All patients received ESWT with a radial probe delivering 3000 2-bar shockwaves at a frequency of 21 Hz to the coccyx per session. Each patient received 4 ESWT sessions 1 week apart. Pain intensity was recorded according to VAS 1, 2, 3 and 4 weeks after starting therapy. The VAS score was also assessed one month and 6 months after the end of therapy. Most subjects were female (90.0%) and the mean age was 39.1 ± 9.1 (ranging from 28 to 52) years. VAS scores did not significantly decrease 7 months after therapy compared to baseline (3.3 ± 3.6 versus 7.3 ± 2.1; p = 0.011). However, the VAS score decreased at 2 months (2.6 ± 2.9 vs. 7.3 ± 2.1; p = 0.007) and 4 weeks (3.2 ± 2.8 vs. 7.3 ± 2 .1, p = 0.007) decreased significantly compared to baseline. The decrease in VAS scores was not sustained after discontinuation of therapy. The authors concluded that ESWT is an effective method to reduce pain intensity in patients with chronic refractory coccyx disease during the immediate postoperative period. Furthermore, they stated that larger placebo-controlled clinical trials with a longer follow-up period are needed to determine the effectiveness of ESWT in the treatment of chronic coccyx disease before it is used in medical practice.
This study had several drawbacks:
- small sample (n = 10) due to the low incidence of the disease. This may negatively affect the validity of the study,
- These researchers used a quasi-experimental study design, meaning they did not include a control or placebo group. Therefore, a placebo effect of the procedure cannot be ruled out,
- short-term follow-up 7 months); Longer follow-up periods are needed to determine long-term outcomes and outcomes, and
- these investigators only used the VAS for clinical assessment, which has its own shortcomings. Other clinical indices should be used in future studies.
(2017) evaluated the outcomes of ESWT in patients with coccyx in a prospective case series study. A total of 23 patients with a mean age of 38.3 ± 12.1 (ranging from 18 to 64) years were included. Most were female (13; 56.5%), had pain for at least 6 weeks (17; 73.9%) and had trauma to the sacrum (17; 73.9%). They had 3 sessions (1 session per week for 3 consecutive weeks) of focused shockwave therapy targeting peak sensitivity in the coccyx; The Numerical Pain Scale (NPS) and Oswestry Disability Index (ODI) were used to assess outcome. Six (26.1%) patients did not complete follow-up due to no or minimal pain relief. After 6 months of follow-up, the median NPS significantly decreased from 7.0 ± 4.0 to 2.0 ± 2.0 in the 17 patients with coccyx (p < 0.001). Median ODI improved from 24.0 ± 9.0 before treatment to 8.0 ± 9.0 at end of follow-up (p<0.001). Before treatment, 12 (70.6%) patients had moderate to severe disability. In contrast, no patient had severe disability and only 1 (5.9%) patient had moderate disability at the end of follow-up (p<0.001). The authors concluded that ESWT had favorable results in the treatment of the coccyx. Most patients experienced partial relief of pain and disability after this therapy. This study had the same limitations as the study mentioned above: small sample size 9n = 230 and short follow-up (6 months). These preliminary results need to be validated by well-designed studies.
Seol et al. (2016) stated that the fabella is a small sesame bone normally located in the tendon of the lateral head of the gastrocnemius behind the lateral condyle of the femur. Fabella syndrome is the occurrence of posterolateral knee pain associated with fabella. It is a rare cause of knee pain that is often misdiagnosed. Fabella syndrome can be treated with conservative or surgical treatment. These investigators applied rESWT as a new treatment strategy for Fabella syndrome and achieved a successful outcome. The authors concluded that larger studies are needed to confirm this finding, establish a treatment protocol for rESWT, and compare focused TOCH with rESWT.
Lee and colleagues (2017) examined the effects of ESWT on pain and function in patients with degenerative knee arthritis. A total of 20 patients were divided into a conservative physical therapy group (n = 10) and an ESWT group (n = 10). Both groups received general conservative physical therapy, and the treatment group received additional ESWT treatment after conservative physical therapy. Both groups were treated 3 times a week over a 4 week period. The VAS was used to assess subjects' knee joint pain, and the Osteoarthritis Index from Western Ontario and McMaster Universities were used to assess subjects' function. Comparison of Western Ontario and McMaster Universities VAS and Osteoarthritis Index scores within each group before and after treatment showed statistically significant reductions in scores in the conservative physical therapy and ESWT groups. A post-treatment group comparison showed statistically significant differences in these values in the ESWT group and the conservative physical therapy group. The authors concluded that ESWT may be a useful non-surgical procedure to reduce pain and improve function in patients with degenerative arthritis of the knee. These preliminary results need to be validated by well-designed studies.
Neurogenic heterotopic ossification after craniocerebral trauma
Reznik and colleagues (2017a) stated that neurogenic heterotopic ossification (NHO) is a complication of neurological injury after traumatic brain injury (TBI) and may be present around large synovial joints. It is often accompanied by severe pain that can lead to limitations in activities of daily living (ADLs). A common procedure in NHO is surgery, which has been reported to carry many additional risks. These investigators evaluated the effect of ESWT on pain in TBI patients with chronic NHO. A series of single-case studies (n = 11) were performed in patients with TBI and chronic hip or knee NHO. Each patient received 4 applications of high-energy EWST to the affected joint over 8 weeks. Follow-up assessments were performed every two weeks, and final assessments were performed 3 and 6 months after the intervention. Pain was measured using the facial rating scale and radiographs were taken at baseline and 6 months after the procedure to physiologically measure the magnitude of NHO. Application of high-energy ESWT was associated with an overall significant reduction in pain in patients with TBI and NHO (Tau-0.412, 95% CI -0.672 to -0.159, p=0.002). The authors concluded that ESWT is a new non-invasive intervention to alleviate pain due to NHO in patients with TBI. These preliminary results need to be validated by well-designed studies.
In a case series study, Reznik and colleagues (2017b) examined the effect of ESWT on hip and knee ROM and function in 11 TBI patients with chronic ONH; ESWT was applied to the hip or knee. Participants received 4 high-energy EWST applications to the affected hip or knee over an 8-week period. Follow-up assessments were performed every two weeks; final assessments were performed 3 and 6 months after the intervention; ROM and functional range (FR) or modified FR (MFR) were measured. Application of high-energy ESWT was associated with a significant improvement in ROM (flexion) of the knee affected by NHO (tau = 0.833, 95% CI 0.391 to 1.276, p = 0.002) and a significant improvement in RF (total tau 0.486, 95 ) Associated % CI: 0.141–0.832, p=0.006); no significant improvement in hip ROM or MFR. The authors concluded that ESWT can improve mobility and balance in TBI patients with chronic ONH. These preliminary results need to be validated by well-designed studies.
Osteochondral lesions of the talus
Gao et al. (2017) noted that several treatment strategies have been developed for osteochondral lesions (OCL) of the talus. In a retrospective study, these investigators evaluated autologous retrograde bone marrow cell (BMC) transplantation via central drilling (CD) combined with ESWT focused on non-displaced OCL of the talus. A total of 69 patients with unilateral talar OCL (Hepple grades I to III) were divided into 2 groups:
- 41 patients received a combined ESWT and BMC transplant therapy (group A) and
- Twenty-eight received BMC transplantation alone (Group B).
The patients were followed clinically and radiologically for at least 2 years. Mean follow-up time was 4.1 ± 2.8 years; American Orthopedic Foot and Ankle Society (AOFAS) scores increased more significantly, while post-treatment pain intensity decreased in Group A compared to Group B scores (p < 0.001). At follow-up with MRI, a more significant improvement in talar OCL was seen in group A compared to group B (p = 0.040). Therefore, the combined technique was a very effective treatment option for LOC of the talus with intact cartilage. Promoted patient recovery with pain control and improved clinical outcome for more than 2 years after surgery.
Disadvantages of this study included
- relatively small sample size (n = 69 for the treatment group),
- relatively short follow-up (at least 2 years),
- The results do not necessarily represent long-term results,
- Patients were retrospectively evaluated,
- Functional improvement of the talus was subjectively assessed using functional and pain scores, without the use of objective measures.
- Due to trauma and medical costs, current patients have declined arthroscopic examination used in previous reports, and accurate assessment of the talar cartilage surface has been nearly impossible, and
- The qualitative evaluation of the regenerated tissue was performed using T2-weighted MRI, which has not yet been standardized.
Sacroiliac joint pain
Moon and colleagues (2017) found that sacroiliac joint pain (SIA) can cause back pain and pelvic discomfort. However, there is no established standard treatment for pain in SIJ; ESWT is a new non-invasive therapy method for musculoskeletal disorders. The mechanism underlying shockwave therapy is not fully understood, but the frequency with which ESWT is used clinically has increased over the years. These investigators evaluated the effectiveness of ESWT in the treatment of SIJ pain. A total of 30 patients with SIJ pain were randomized to ESWT (n=15) and sham control (n=15) groups. The ESWT group received 2000 shock waves with energy set at the maximum tolerable level for the patient (energy density = 0.09 to 0.25 mJ/mm2). The probe was oriented perpendicular to the posterior SI joint line and moved up and down along the joint line. The sham control group received 2000 shockwaves with the probe aligned parallel to the posterior SIJ line. A 10 cm numerical rating scale (NRS) and Oswestry Disability Index (ODI) scores were assessed before the intervention and at 1 and 4 weeks after the intervention. Participants were instructed to refrain from any other conservative treatment, including anti-inflammatories and other physical modalities, during the study. In the ESWT group, NRS significantly decreased at week 4 after treatment (3.64 [95% CI: 2.29 to 4.99]) compared to baseline (6.42 [5.19 to 7. 66], p<0.05); ODI improved after 1 and 4 weeks compared to baseline, but not significantly. In the sham group, NRS and ODI did not differ at any time after treatment. There was a significant difference between groups in NRS at week 4 post-treatment (3.64 [2.29 to 4.99] in the ESWT group versus 6.18 [5.34 to 7.02] in the sham control; p< 0.05), but this was not the case for ODI. The authors concluded that ESWT is a possible therapeutic option to reduce SI joint pain.
Thomson et al. (2017) noted that osteonecrosis of the sesamoid bone is a disabling condition that causes severe forefoot pain for which there are limited therapeutic options. These investigators presented the case of a 52-year-old man with a year-long pain aggravated by walking and playing tennis. On examination, the pain was localized to the plantar side of the first metatarsophalangeal (MTP) joint. Imaging showed development of end-stage avascular necrosis of the lateral sesamoid bone with early secondary degenerative changes. Previous extensive conservative treatment failed to relieve her pain. rESWT has been proposed as an alternative to surgery. The treatment protocol consisted of 2,000 pulses at a frequency of 5 Hz and the pressure varied between 1.2 and 1.8 bar depending on the patient's tolerance. A total of 8 sessions were held. At the end of treatment, the patient reported little or no pain and was able to play tennis again without recurrence. The authors proposed rESWT as a new effective conservative treatment for sesamoid osteonecrosis. These preliminary results need to be validated by well-designed studies.
Ruptur des Schulterblatts (scapulothoracic bursitis)
Acar and colleagues (2017) stated that scapular bursitis is often a misdiagnosed problem; and ESWT has been used successfully in the treatment of many chronic inflammatory diseases. In an RCT, these investigators evaluated and compared the efficacy of ESWT in the treatment of scapulothoracic bursitis with corticosteroid injection. A total of 43 patients with scapulothoracic bursitis were divided into two groups: Group 1 (n = 22) received 3 sessions of ESWT and Group 2 (n = 21) received a single local injection of 80 mg of methylprednisolone; VAS scores were recorded at each follow-up visit, while satisfaction levels were assessed using the Roles and Maudsley criteria. In Group 1, mean VAS scores at 1, 2, 3, and 6 months were 39, 30, 27, and 16, respectively, while in Group 2, mean VAS scores were 46, 44, 35, and 36, respectively. There was no statistical significance between the 2 groups in the 1st and 2nd month. However, at 3 and 6 months, group 1 had lower mean VAS scores compared to group 2 (p values of 0.012 and 0.001, respectively). The Roles and Maudsley criteria showed that patients in the first group were 46% excellent, 36% good, 14% fair and 4% poor. However, the results of patients in the second group were 24% excellent, 33% good, 19% fair and 24% poor. The authors concluded that ESWT is a beneficial treatment modality and can be strongly recommended in painful cases of scapulothoracic bursitis. Furthermore, they indicated that further studies should be conducted in a larger population of patients using different ESWT protocols. This study had several drawbacks:
- small sample size (n = 22 for the treatment group),
- Short-term follow-up (6 months) and
- A single ESWT (low energy) protocol was used.
Pain in the lower back
Notarnicola et al (2018) found that physical therapy treatment of low back pain with physical stimulation has multiple applications. The previous physical therapies for lower back pain are laser therapy, ultrasound and electricity therapy. These investigators conducted a clinical study to see whether ESWT results in clinical and electromyographic (EMG) improvement in patients affected by low back pain. They randomly assigned 30 patients with back pain to be treated with either shockwaves (ESWT group) or a standard protocol with rehabilitation exercises (control group). At 1 and 3 months, ESBT-treated patients demonstrated clinical improvement as measured by the VAS scales (p=0.002; p=0.02) and disability assessed by the Roland (p=0.002; p=0.002) and ODI scales (p= 0.002, p=0.002). After 3 months, patients treated with ESWT showed a significant improvement in medial plantar nerve (SNCV) sensory nerve conduction velocity amplitude values (left: p=0.007; right: p=0.04). (MNCV) of the deep peroneal nerve (left: p=0.28; right: p=0.01) and recruitment of the extensor motor unit of the short finger (left: p=0.02; right: p=0.006). In the control group, there was a trend towards an increase in clinical and electromyographic results without statistical significance. The authors concluded that these preliminary results indicate good applicability of ESWT in the treatment of low back pain, consistent with the anti-inflammatory, analgesic, decontracting and remodeling effects of nerve fiber damage confirmed in previous studies carried out in other pathologies. Models They indicated that future research will allow clinicians to validate the integration of this therapy into a rehabilitation protocol in combination with other physical therapies.
In a systematic review and meta-analysis, Yue et al. (2021) the safety and efficacy of ESWT for the treatment of chronic low back pain (CLBP). This study was conducted in accordance with PRISMA guidelines. These investigators identified relevant studies by searching multiple electronic databases, study registries, and websites and checking reference lists through April 30, 2021. They selected RCTs that compared ESWT in unimodal or multimodal therapeutic approaches with sham ESWT or other active therapies; and 2 investigators independently extracted data and assessed risk of bias and quality of evidence. The main outcomes were pain intensity and disability status assessed as MDS with 95% CI. Risk of bias was assessed using the Cochrane Back and Neck (CBN) Group risk of bias tool and Jadad score, and GRADE was applied to determine confidence in effect estimates. Heterogeneity was examined using sensitivity analysis and meta-regression. A total of 10 RCTs were identified, including a total of 455 young to middle-aged individuals (29.2 to 55.8 years old). Compared to the control group, the ESWT group had lower pain intensity at month 1 (SMD = -0.81, 95% CI -1.21 to -0.42) and a lower disability score, which was lower at month 1 (SMD = -1.45, 95% CI). -2.68 to -0.22) and Month 3 (SMD = -0.69, 95% CI -1.08 to -0.31). No serious adverse events associated with shock waves have been reported. The authors concluded that the use of ESWT in patients with CLBP resulted in a significant and measurable reduction in short-term pain and disability; However, better conducted RCTs (with larger sample sizes, more specific information on randomization and assignment concealment, and patient and rater blinding) are needed to generate high-quality evidence and promote the use of TOCH in clinical practice.
The authors stated that this review had several drawbacks. First, the results were based on studies with a small sample size, which may have overestimated the effect size and hindered the planned subgroup analysis. Second, included studies were clinically diverse in terms of etiology, pain duration, treatment sessions/dose/time, and comparators, leading to heterogeneity in effect estimates and limited generalizability of evidence. Third, long-term follow-up and data from ongoing studies were not available. These researchers indicated that, with these limitations, the results should be interpreted with caution.
Osteonecrosis of the femoral head
In a retrospective study, Xie and colleagues (2018) determined the long-term outcomes of ESOT for ONFH. Between January 2005 and July 2006, a total of 53 hips in 39 consecutive patients were treated with ESWT at the authors' hospital; In this study, 44 hips in 31 patients with stage I-III non-traumatic ONFH were examined according to the Association Research Circulation Osseous (ARCO) system. VAS, Harris hip score, X-rays and MRI were used to estimate treatment outcomes. ONFH progression was assessed by imaging and clinical outcomes. Outcomes were classified as clinical success (no progression of hip symptoms) and imaging success (no stage or substage progression on X-ray and MRI). The mean follow-up time was 130.6 months (ranging from 121 to 138 months). Mean VAS decreased from 3.8 before TOCH to 2.2 points after 10 years of follow-up (p < 0.001). The mean Harris hip score improved from 77.4 before TOCH to 86.9 points at 10 years of follow-up. Clinical success rates were 87.5% in ARC Stage I patients, 71.4% in ARC Stage II patients, and 75.0% in ARC Stage III patients. Imaging success was observed in all stage I hips, 64.3% of stage II hips, and 12.5% of stage III hips; 17 hips showed ARC stage/substage progression on imaging; 8 hips presented femoral head collapse after 10 years of follow-up; 4 ARCO stage III hips and 1 ARCO stage II hip underwent total hip arthroplasty during follow-up; 3 were performed 1 year after ESBT, 1 at 2 years and 1 at 5 years. The authors concluded that these results suggest that ESWT is an effective treatment modality for non-traumatic ONFH that results in pain relief and restoration of function, particularly in patients with ARC stage I-II ONFH. Furthermore, they indicated that more large-scale RCTs are needed to confirm the efficacy of ESWT for early-stage non-traumatic ONFH.
The authors stated that this study had several drawbacks. First, the current study was limited by its retrospective design. Second, the limited number of participants (n = 39) may have influenced the evaluation of results. Third, there was no control group. A comparison between ESWT and other treatments would be helpful in determining the superiority of ESWT in the treatment of ONFH in well-selected patients.
In a systematic review, Sconza et al. (2022) reviewed the available evidence on the use of ESWT for the treatment of osteonecrosis (ON) and vascular bone disease (BVD) to understand its therapeutic potential and compare it to other therapies. Data sources included PubMed, Scopus, Science Direct, and Research Gate with the following inclusion criteria: RCTs in English published in indexed journals within the last 25 years (1995 to 2020) investigating the use of ESWT to treat the subject's BVD or AN. The risk of bias was assessed using the Cochrane Risk of Bias tool for RCTs. A total of 5 studies with 199 patients (68 women and 131 men) were included. Patients in the control groups received different treatments, such as surgery, bisphosphonates in combination with prostacyclin or ESWT, and hyperbaric oxygen therapy (HBO). Regarding the quality of the available literature, none of the included studies can be considered a “good” study; only 1 was classified as 'adequate' and the rest were classified as 'poor'. No major complications or serious adverse events were reported in any of the included studies. Based on available data, ESWT may provide rapid pain relief and functional improvement. The authors concluded that the literature review revealed low quality of the method and that most of the studies were flawed due to relevant biases. These investigators determined that ESWT has the potential to be a useful conservative treatment for bone degeneration due to impaired vascular and tissue turnover.
Carpal tunnel syndrome
Atthakomol and colleagues (2018) noted that recent studies reported that radial TOCH (ESWT) reduced pain and improved function in patients with mild to moderate carpal tunnel syndrome (CTS) compared with placebo. However, most of these studies used multisession rESWT in combination with a wrist brace, and efficacy evaluation was limited to a maximum of 14 weeks. In a prospective RCT, these investigators compared the efficacy of a single dose of rESWT and local corticosteroid injection (LCsI) in reducing pain and improving clinical function over the medium term (24 weeks). A total of 25 patients with mild to moderate CTS were randomized to receive a single dose of rESWT (n=13) or LCsI (n=12). Primary outcomes were assessed using the Boston Self-Assessment Questionnaire (BQ), while secondary outcomes used VAS and electrodiagnostic parameters. Assessments were made at baseline and 1, 4, 12 and 24 weeks after treatment. At Weeks 12 to 24, there was significantly greater improvement in symptom severity scores, functional scores, and Boston Questionnaire scores in the rESWT group compared to the LCsI group. Compared to baseline, there was a significant reduction in VAS and functional score in the rESWT group at weeks 12 and 24. The LCsI group showed no statistically significant difference in VAS and functional score reduction over the same period. The authors concluded that treatment of CTS with a single dose of rOCT had a spillover effect lasting up to 24 weeks, suggesting that a single dose of rOCT was appropriate for the treatment of mild to moderate CTS and provided longer-lasting benefits than LCSI. Furthermore, they indicated that future studies should include a larger number of patients, different treatment protocols and longer follow-up periods.
The authors stated that a disadvantage of this study was the relatively small number of patients (n=13 in the rESWT group) compared to other studies, although this sample had sufficient statistical power to postulate a significant difference between groups at 12 weeks 24. A a The second drawback was that different rESWT dose intensities could affect treatment outcomes. Long-term outcomes beyond 24 weeks were also not measured.
Kim and colleagues (2020) noted that although several studies have reported the use of ESWT in mild to moderate CTS, little is known about the effectiveness of ESWT. In a meta-analysis, these investigators examined whether ESWT could improve symptoms, functional outcomes, and electrophysiological parameters in CTS. A total of 6 RCTs examining the effect of ESWT on CTS were retrieved from PubMed, Embase and the Cochrane Library. They performed a paired meta-analysis using fixed or random effects models. TOCH demonstrated a significant overall effect size compared to control (total hedge g pooled SMD = 1.447, 95% CI 0.439 to 2.456, p = 0.005). Symptoms, functional outcomes, and electrophysiological parameters improved with ESWT treatment. However, there was no apparent difference between the effectiveness of ESWT and local corticosteroid injection (pooled SMD = 0.418, 95% CI -0.131 to 0.968, p = 0.135). A publication bias was not evident in this study. The authors concluded that the results of this meta-analysis showed that ESWT could improve symptoms, functional outcomes and electrophysiological parameters in patients with CTS. Furthermore, these investigators indicated that further research is needed to confirm the long-term effects and optimal TOCH protocol for CTS.
The authors stated that this study had several drawbacks. First, the number of studies that met the criteria was small (n=6). As ESWT has recently been used to treat CTS, the number of studies that met the selection criteria may be small. If a sufficient number of studies had been included, comparisons of ESWT types or the effect of corticosteroid injections in subgroup analyzes might have provided more powerful evidence. Second, the patient population was limited to those with mild to moderate CTS because no studies have attempted to examine the effect of ESWT on severe CTS. As the main option for severe cases of CTS (accompanied by motor weakness) is surgical treatment, studies examining the effect of ESWT on severe CTS are lacking. However, when the efficacy and mechanisms of ESWT are clear and evident, it needs to be examined whether this approach can also be used in the treatment of severe CTS. Finally, data on the long-term effects of ESWT are lacking. The duration of follow-up for the included studies ranged from 12 to 24 weeks. Clinical research should investigate the long-term effects of more than 1 year of follow-up.
Chen et al. (2022) reported that wrist immobilization was a conservative treatment for CTS; the addition of ESWT offers an alternative treatment. However, strong evidence for the effectiveness of ESWT in CTS is still lacking. In a systematic review and meta-analysis, these investigators evaluated the safety and efficacy of ESWT compared to overnight wrist splint treatments alone in patients with CTS. No limiting criteria were used for study selection in this study. All available articles comparing the effectiveness of ESOT in combination with a night wrist splint and a night wrist splint alone for the treatment of CTS published up to 20 January 2022 were identified in PubMed, Embase, and Cochrane Central Register databases. Controlled Trials Central. The primary endpoints were an SMD with a 95% CI for improvement in symptom severity and functional impairment between the two groups. In an attempt to analyze time trends in studies reporting repeated measures, a meta-analysis (ATM) of all time points was performed. A total of 7 RCTs with 376 participants were included in this study. Significant improvements in functional impairment and symptom remission were seen only in the ESWT group 4 weeks after treatment; TOCH did not demonstrate superior efficacy compared to overnight wrist splint treatment alone at 8 to 10 and 12 to 14 weeks after treatment or using the temporomandibular approach. The authors concluded that the therapeutic effect of ESWT was transient and, for the most part, insignificant compared to the use of a night wrist splint alone. Serious side effects were not reported in all included studies. Other conservative treatments are needed to improve carpal tunnel syndrome symptoms. These investigators indicated that future studies should focus on other conservative treatments that may have a longer therapeutic duration in patients with CTS.
The authors stated that this study had several drawbacks. First, the number of studies and patients included was small, which can lead to high variability and impair internal and external validity. Second, most of the included studies had a follow-up period of four to 14 weeks, and the long-term clinical efficacy of ESWT remained uncertain. However, no significant therapeutic benefit was seen at 8-10 and 12-14 weeks after treatment; Furthermore, the ATM approach also did not trend significantly toward improvement after ESWT over time, indicating that the benefits of ESWT were only temporary. Last but not least, although only RCTs and well-controlled intervention studies were considered for inclusion, there are still potential sources of bias in these studies, including inadequate methods of blinding randomization as well as lack of blinding.
Osteoarthritis of the carpometacarpal joint
Ioppolo and colleagues (2018) compared ESWT to intra-articular hyaluronic acid (HA) injections in terms of pain relief, improvement in hand function, and strength in patients with osteoarthritis of the first carpometacarpal (CMC) joint. A total of 58 patients received targeted injection of ESWT (n=28) or HA (n=30) once a week for 3 consecutive weeks. In the ESWT group, 2400 consecutive pulses with a frequency of 4 Hz and an energy flux density of 0.09 mJ/mm2 were performed during each treatment session. The HA group underwent a cycle of 3 injections of 0.5 cc of HA. The most important outcome parameters were pain and hand function, measured with the VAS and the Duruoz Hand Index (DHI); secondary outcomes were grip and pinch strength. Each assessment was performed at baseline, at the end of treatment, and at the 3- and 6-month follow-up visits. Based on VAS and DHI scores, there was a significant change in test performance over time in both groups (p < 0.001), with a greater mean improvement in pain symptomatology at 6-month follow-up in the TOCH group. A significant improvement in strength was seen in both groups, but the ESWT group showed better results in the pinch test, which began immediately after the end of treatment. The authors concluded that the use of ESWT in patients with osteoarthritis of the first CMC joint resulted in reduced pain, improved pinch test performance lasting at least 6 months, and reduced hand disability for up to 6 months. visit above. In addition, they stated that these results are encouraging and that it would be interesting to carry out further studies on the long-term effects of this technique in a larger number of patients. These researchers stated that this study had two main drawbacks, namely the lack of a placebo group and a relatively small number of patients. (n = 28 in the TOCH group)
Harwood and colleagues (2018) found that intermittent claudication is the most common symptom of peripheral artery disease. Previous research has suggested that ESWT can induce angiogenesis in treated tissue. In a pilot study, these researchers evaluated the safety, tolerability, and efficacy of ESWT as a new treatment. Patients with unilateral claudication were randomized to either ESWT or calf muscle sham treatment 3 times a week for 3 weeks. Primary endpoints were pain-free distance walked (PFWD) and maximum distance walked (MWD); Secondary endpoints included safety and tolerability of ESWT treatment, ankle-brachial index (ABI) before and after exercise, and quality of life as measured by a general health survey (36-item short-form health survey, EuroQol -5 dimension 3 level) has been classified. and specific disease (vascular overview). QOL). Participants were assessed at baseline and 4, 8, and 12 weeks after treatment. Feasibility outcomes included recruitment and attendance rates for treatment and follow-up. A total of 30 patients were recruited. Statistically significant (p<0.05) improvements were seen at all time points in the active treatment group for MWD and PFWD compared to the sham group; At 12 weeks post-treatment, PFWD in the active group improved by 276% and MWD in the active group improved by 167%. In this study, there were no immediate or delayed concerns about treatment safety and no documented adverse events from ESBT treatment. The authors concluded that ESWT was safe and well tolerated when used on the calf and showed significant improvements in the distance walked. Current conservative treatment of intermittent claudication includes supervised exercise. They stated that early results with ESWT showed great potential as an alternative non-invasive therapy option. The mechanism of action, durability of clinical effect and cost-effectiveness of ESWT in claudication require further investigation.
In a randomized, double-blind, placebo-controlled pilot study, Green et al. (2018) evaluated the mid-term efficacy of ESWT for the treatment of intermittent claudication. Patients with unilateral intermittent claudication were randomized 1:1 to receive ESWT or sham treatment 3 sessions per week for 3 weeks. Primary endpoints were MWD and intermittent claudication distance using a fixed-load treadmill test; Secondary endpoints included pre- and post-exercise ABI, safety, and QoL assessed using global (SF36, EQ-5D-3L) and disease-specific (vascular QoL) measures. All outcome measures were assessed 12 months after treatment. A total of 30 subjects were enrolled in the study (ESWT, n=15; simulated, n=15), with 26 being followed and analyzed at 12 months (ESWT, n=13; simulated, n=13). Within-group analysis showed significant improvements in MWD, intermittent claudication distance, and ABI after exercise (p < 0.05) in the active treatment group, with no improvements in ABI before exercise. Significant improvements in quality of life were seen in 3 of the 19 domains tested in the active group. A reoperation rate of 26.7% was observed in both groups. The authors concluded that these results suggest that ESWT is effective in improving walking distances at 12 months. Furthermore, they stated that although this study provided important pilot data, a larger study is needed to substantiate these findings and examine the effects of this treatment.
Bereket and colleagues (2018) noted that distraction osteogenesis (DO) is used to treat bone deformities; ESWT is a new non-invasive method to manage bone regeneration. These investigators examined the effects of 2 different single doses of ESWT on the period of union of the rabbit OD mandible using stereological, radiological and immunohistochemical methods. Unilateral osteogenic distraction was performed on the jaws of 18 New Zealand rabbits (age 6 months, weight 2.5 to 3 kg). The mandibular distraction zone was not treated as a control. Group 2 (ESWT 500) received ESWT (single dose of 500 pulses of 0.19 mJ/mm energy flow intensity and 2155 mJ total) delivered on the first day of consolidation. Group 3 (ESWT 1000) treated with ESWT (single dose of 1000 pulses with energy flux intensity of 0.19 mJ/mm and total of 4310 mJ) was applied on the first day of the consolidation period. After sacrifice, bone mineral density (BMD), new bone formation, new fibrous tissue formation and new vessel formation were analyzed radiographically using unbiased stereological methods. These investigators found a statistically significant difference between the study groups and the control group in BMD measurements, with the highest values being found in the ESWT 1000 group. Regarding the stereological analysis, there was a significant difference between the study and control groups ( p = 0.00). The new capillary volume was greater in the ESWT 1000 group. Furthermore, significant differences in capillary volumes were observed between the control group and ESWT 500- (p = 0.001), control and ESWT 1000- (p = 0.000), found ESWT 500- . or ESWT 1000 (p = 0.040). The authors concluded that a total of 1000 ESWT pulses can induce growth factors to enhance regeneration of newly formed bone. These results need to be validated in studies with volunteers.
soft tissue injuries
Zhang and colleagues (2018) examined the effects of ESWT and conventional wound therapy (CWT) on acute and chronic soft tissue wounds. All articles in English on ESWT for acute and chronic soft tissue wounds published before June 2017 and indexed in PubMed, Medline, Embase, Cochrane Central Register of Controlled Trials, Cochrane Library, Physiotherapy Evidence Database and HealthSTAR were included. Articles cited in reference lists of related review articles. The methodological quality of selected studies was assessed using the Cochrane Collaboration's "Risk of Bias" tool. Study design, patient demographics, wound etiology, treatment protocols, scoring indices, and duration of follow-up were extracted. Fixed or random effects model was used to calculate pooled effect sizes based on study heterogeneity. A total of 10 RCTs with 473 patients were included in this systematic review and meta-analysis. Meta-analysis showed that ESWT statistically significantly increased the rate of healing of acute and chronic soft tissue wounds by a factor of 2.73 (OR = 3.73, 95% CI 2.30 to 6.04, p < 0.001 ) and the percentage of wound healing area improved by 30.45%. (SMD = 30.45; 95% CI: 23.79 to 37.12; p<0.001). ESWT reduced wound healing time by 3 days (SMD=-2.86, 95% CI: -3.78 to -1.95, p<0.001) in acute soft tissue wounds and by 19 days (SMD= -19.11, 95% CI: -23.74 to -14.47, p<0.001) for chronic soft tissue wounds and the risk of wound infection at 53% (OR=0.47, 95% CI% : 0.24 to 0.92, p=0.03) compared to CWT alone. No serious side effects have been reported. The authors concluded that TOCH showed better therapeutic effects in acute and chronic soft tissue wounds compared to OCD alone. Furthermore, they stated that well-controlled, high-quality RCTs are needed to better assess the role of ESWT in acute and chronic soft tissue wounds.
Lower limb ulceration
Butterworth and others. (2015) stated that ESWT has been reported as an effective treatment for lower extremity ulcerations. These investigators investigated the efficacy of ESWT for the treatment of lower extremity ulcerations. Five electronic databases (Ovid MEDLINE, CINAHL, Web of Knowledge, Scopus, and Ovid AMED) and reference lists of relevant studies were searched in December 2013. All study designs, except case reports, were searched in this revision. The methodological quality of individual studies was assessed using the quality index tool. Study effectiveness was measured by calculating effect sizes (Cohen's d) from mean values and standard deviations. A total of 5 studies including; 3 RCTs, 1 quasi-experimental study and 1 case series design met the inclusion criteria and were reviewed. Quality assessment results ranged from 38% to 63% (mean 53%). Improvements in wound healing after ESWT were seen in these studies. The majority of wounds evaluated were diabetes related and the effectiveness of ESWT as an adjunct to standard of care was evaluated in only 1 RCT. The authors concluded that, given the limited evidence identified, more research is needed to support the use of ESWT in the treatment of lower limb ulcerations.
In a Cochrane review, Cooper and Bahoo (2018) examined the effects of ESWT on the healing and treatment of venous leg ulcers. In April 2018, these researchers searched the Cochrane Wounds Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid Medline (including running and other non-indexed citations); Ovid Embase and EBSCO CINAHL Plus. They also searched clinical trial registries for ongoing and unpublished studies and reference lists of relevant included studies, as well as reviews, meta-analyses, and health technology reports to identify additional studies. These investigators did not apply language, publication date, or study setting restrictions. They considered all published and unpublished RCTs evaluating the effectiveness of ESWT in healing and treating venous leg ulcers. Two reviewers independently performed the selection of studies. They planned that two reviewers would also assess the risk of bias of the included studies, extract the study data, and grade the certainty of the evidence with GRADE. These investigators found no RCTs that met the inclusion criteria for this review. The authors concluded that the lack of high-quality evidence in this area highlights a research gap and may serve to justify the need for more research and evidence to provide guidance on the use of ESWT for this condition. Furthermore, they indicated that future studies should have a clear design and include the concomitant use of the current best practice treatment, layered compression therapy. Recruitment should aim to better represent patients seen in clinical practice, and patient-related outcome measures should be included in the study design.
lower limb conditions
In a meta-analysis, Liao and colleagues (2018) examined the clinical effectiveness of ESWT in soft knee disorders (KSTDs) and compared the effectiveness of different types of shockwaves, energy levels, and intervention durations. These researchers conducted a comprehensive search of online databases and search engines, with no restrictions on year of publication or language. They selected RCTs reporting the effectiveness of ESBT in KSTD and included them in a meta-analysis and risk of bias assessment. Pooled ESWT effect sizes were estimated by calculating OR with 95% CI for treatment success rate (TSR) and SMD with 95% CI for pain reduction (i.e., difference in pain relief, i.e., change in pain from start to finish). 🇧🇷 at the end of RCTs between treatment and control groups) and to restore knee range of motion. These investigators included 19 RCTs, all of moderate or high methodological quality and with a physical therapy baseline evidence score of at least 5/10. Overall, ESWT had significant global effects on RRT (OR: 3.36, 95% CI: 1.84 to 6.12, p < 0.0001), pain reduction (SMD: -1.49, 95% CI : -2.11 to -0.87, p<0.00001) and ROM recovery (SMD: 1.76, 95% CI: 1.43 to 2.09, p<0.00001). Subgroup analyzes revealed that focal SWT (FoSWT) and radial SWT (SWT) applied for a longer period of time (greater than or equal to 1 month) had significant effects in reducing pain, with corresponding SMDs -3.13 (CI 95 %: - 5.70 to - 0.56; p = 0.02) or - 1.80 (95% CI: - 2.52 to - 1.08; p < 0.00001). Low-energy FoSWT may be more effective for TSR than high-energy FoSWT, while the opposite result was observed for RaSWT. The authors concluded that ESWT exerted an overall effect on RRT, pain reduction, and range of motion recovery in KSTD patients. These researchers indicated that shockwave types and levels of application made different contributions to treatment efficacy for KSTDs that need further investigation to optimize these treatments in clinical practice.
Chronic kidney disease and scleroderma
Skov-Jeppesen and colleagues (2019) noted that ESWT is a new treatment modality to stimulate tissue regeneration and anti-fibrosis. These researchers summarized the use of ESWT for erectile dysfunction, diabetic foot ulcers (DFU), PD, chronic kidney disease (CKD), and scleroderma. The authors concluded that ESWT for CKD and scleroderma is still experimental.
Preoperative ESWT for Scar Reduction After Abdominoplasty
Russe and colleagues (2020) noted that ESWT proved to be a viable non-invasive method to improve wound healing. This effect has been shown to result from increased perfusion and angiogenesis due to systemic growth factor expression. These researchers hypothesized that preoperative ESWT would reduce scarring after surgery. In a prospective, controlled pilot study of 24 patients undergoing abdominoplasty, these investigators evaluated the efficacy of preoperative low-energy, focus-free EWST. The right and left halves of the surgical site were randomly assigned to ESWT or placebo treatment in an in-patient control design. At 6 and 12 weeks postoperatively, healing was assessed using 19 different scar parameters included in the patient, observer scar assessment, and Vancouver Scar Scale. The overall assessment of the Vancouver scale and POSAS with the Mann-Whitney (MW) analysis showed a clear trend in favor of TOCH. At week 6, 7 out of 19 parameters were clearly in favor of the ESWT (mean > > 0.53). At week 12, 8 out of 19 parameters were clearly in favor of ESWT. The biggest differences were in thickness and overall impression (Vancouver scar scale). The authors concluded that ESWT is likely to reduce scarring and postoperative symptoms after abdominoplasty surgery. Furthermore, these researchers stated that further studies are needed to confirm the effectiveness of ESWT with statistical significance.
Break et al. (2008) noted that the non-surgical treatment of chronic tendinopathy of the Achilles tendon insertion has been poorly studied. With the recently demonstrated efficacy of eccentric loading and repetitive low-energy shock wave therapy in patients with medium substance Achilles tendinitis, the aim of the present randomized controlled trial (RCT) was to evaluate the efficacy of both procedures exclusively in patients with Achilles tendinitis insertion tendonitis. Tendinopathy A total of 50 patients with chronic recurrent insertional Achilles tendinopathy (6 months or longer) were included in this study. All patients received unsuccessful treatment for at least 3 months, including local anesthetics and/or corticosteroid injections, prescription nonsteroidal anti-inflammatory drugs (NSAIDs), and physical therapy. A computerized random number generator was used to develop an allocation plan; 25 patients were allocated to eccentric loading (group 1) and 25 patients to repetitive low-energy shock wave therapy (group 2). Analysis was performed by Intention to Treat (ITT). The primary follow-up examination took place after 4 months, after which patients were allowed to switch. The last follow-up examination was 1 year after completion of initial treatment. Patients were assessed for pain, function, and activity using a validated questionnaire (VISA-A questionnaire, Victorian Institute of Sport Assessment-Achilles [VISA-A]). 4 months after the beginning of the study, the mean VISA A score increased in both groups, from 53 to 63 points in group 1 and from 53 to 80 points in group 2. The mean pain score decreased from 7 to 5 points in the Groups 1 and 7 to 3 points in Group 2; 7 patients (28%) in Group 1 and 16 patients (64%) in Group 2 reported full recovery or great improvement. For all endpoints, the shock wave therapy group showed significantly more favorable results than the eccentric loading group (p = 0.002 to p = 0.04). After 4 months, 18 of the 25 patients in Group I and 8 of the 25 patients in Group 2 opted for the crossover. Favorable outcomes after shockwave therapy at 4 months were stable at the 1-year follow-up assessment. 🇧🇷 The authors concluded that the eccentric load used in the present study had worse results than the low-energy shockwave therapy used in patients with chronic recalcitrant tendinopathy of the Achilles tendon insertion at the 4-month follow-up. These investigators indicated that more research is needed to better define the indications for this treatment modality.
Saxena and colleagues (2011) evaluated the efficacy of 3-week pulse-activated extracorporeal therapies (EPAT) in patients with Achilles tendonitis, as quantified by the Roles and Maudsley score. A total of 74 tendons were examined in 60 patients at baseline and at least 1 year after treatment, including 32 (43.24%) paratendinous tendons, 23 (31.08%) proximal tendons, and 19 (25.68%) tendons. of insertion. The mean age of participants was 48.6 ± 12.94 years, and patients with paratendinosis (41.44 ± 14.01 years) were significantly younger than patients with proximal tendinopathy (53 ± 8.9 years ) and insertional tendinopathy (54.26 ± 9.74 years) and these differences were statistically significant (p = 0.0012 and p = 0.0063, respectively). Overall, 58 (78.38%) tendons improved at least 1 year after treatment, including 75% in the paratendinosis, 78.26% in the proximal tendinosis, and 84.21% in the insertional tendinosis groups, and no side effects were reported. observed. The Roles and Maudsley score improved from 3.22 ± 0.55 to 1.84 ± 1.05 (p < 0.0001) in the paratendinosis group, from 3.39 ± 0.5 to 1.57 ± 0.66 (p < 0.0001) in the proximal tendinopathy group and from 3.32 ± 0.58 to 1.47 ± 0.7 (p = 0.0001) in the insertional tendinopathy group. Based on these results, the authors consider EPAT to be a safe, viable and effective option for the treatment of Achilles tendinopathy. While these results were promising, lack of randomization, control group, and blinding limited the usefulness of these data. Well-designed studies are needed to determine the safety and efficacy of EPAT.
Al-Abbbad and Simon (2013) stated that extracorporeal shock wave therapy (ESWT) should be an effective alternative to surgery for Achilles tendonitis when other conservative therapies fail. In a systematic review, these investigators examined the effectiveness of ESWT in the treatment of insertional and non-insertional Achilles tendonitis. Using a comprehensive article search strategy, electronic searches were conducted in the Cochrane Register of Controlled Trials, Medline, CINAHL, Embase and SPORTDiscus. Studies were included if they were prospective clinical studies investigating the effectiveness of ESWT in insertional and non-insertive Achilles tendon disorders. The methodological quality of the included studies was assessed using the PEDro scale and the modified McMaster tool. The strength of evidence was reported using the National Council for Health and Medical Research Evidence Framework. A narrative summary of the results was presented; 4 of the included studies were RCTs and 2 were pre-post study designs. Common methodological flaws included failure to blind the clinician or participants. There was consistent evidence from 4 reviewed studies of the effectiveness of ESWT in the treatment of patients with chronic Achilles tendinopathy with a minimum follow-up of 3 months. The authors concluded that the results of this review provided satisfactory evidence for the efficacy of low-energy ESWT in the treatment of chronic insertional and non-insertional Achilles tendinopathies with a minimum follow-up of 3 months before surgery is considered when other treatments have failed. However, combining ESWT with eccentric loading seemed to show better results.
In a systematic review, Korakakis et al. (2018) reviewed ESWT in the treatment of Achilles tendon (AT) tendinopathy, greater trochanteric pain syndrome (GTPS), medial tibial stress syndrome (MTSS), patellar tendinopathy (PT), and proximal hamstring tendinopathy (PT). PT). Randomized and non-randomized studies evaluating OLCT in patients with AT, GTPS, MTSS, PT and PHT were included; and assessed risk of bias and study quality. Proposed evidence at a moderate level
- no short- and mid-term differences between focused ESWT and placebo ESWT in PT; Y
- Radial TOCH was superior to conservative treatment in PH in the short, medium and long term.
Low evidence indicated that OCBT
- it is comparable to eccentric training but superior to the 4-month wait-and-see policy in the middle part of the AT;
- was superior to eccentric training at 4 months at insertion AT;
- less effective than corticosteroid injection in the short term, but TOCH had superior results in GTPS in the medium and long term;
- achieves results comparable to control treatment in GTPS over a long period of time; Y
- was superior to long-term conservative control treatment in PT.
As for the rest of the results, there was very little or no evidence; Thirteen studies showed a high risk of bias mainly due to methodology, blinding and reporting. The authors concluded that low-level evidence suggests that ESWT may be effective for some lower-extremity disorders at all stages of rehabilitation.
The authors stated that a limitation of the research in this area and a possible bias was that a relatively small number of research groups make up most of the research (approximately 50% of the studies included in the quantitative analysis here) in this area. Another limitation concerns the inclusion criteria of the studies, which were considered variable and somewhat arbitrary. It is increasingly observed that there is a weak association between radiologically identified abnormalities and pathology. Likewise, the variability and imprecision associated with the clinical examination created potentially insurmountable difficulties in standardizing treatment groups. Finally, variability in treatment protocols (in terms of energy delivered and total number of sessions) as well as in patients included made generalization difficult. Furthermore, these investigators stated that shockwave therapy is rarely used as a monotherapy; future studies should evaluate more clinically oriented protocols as well as individualized protocols in terms of clinical efficacy; and a research consensus on methodological standardization, reporting guidelines, and applicability/adequacy of selected quality assessment tools with respect to study design is essential.
Nikolikj-Dimitrova et al. (2018) evaluated the effects of low-energy radial ESWT (RESWT) in the treatment of chronic insertional TA in adults after unsuccessful conservative treatment with an 18-month follow-up. These investigators reported the case of a 55-year-old man who had been suffering from severe pain in his right heel for 4 months. Because of his chronic AT insertion in the right heel, he was treated conservatively at the Institute of Physical Medicine and Rehabilitation. Numerical rating scale (NRS) for pain, ankle range of motion (ROM) and Roles-Maudsley score (RMS) to assess function were used for outcome assessment. At first the pain was severe and he was treated with physiotherapy. After unsuccessful conservative treatment, he underwent RESWT treatment; NRS significantly decreased at immediate, short-term and long-term follow-up. After the last treatment, the patient was pain-free and function, as assessed by the Roles-Maudsley score, was excellent. After 3, 6, 12 and 18 months of follow-up, the patient was asymptomatic and with excellent functional results. The authors concluded that long-term radial ESWT is a safe and effective treatment for patients with chronic insertional TA. Furthermore, these investigators indicated that further research is needed to better define the appropriate dose, treatment interval, and number of sessions to achieve good and excellent clinical outcome.
In a randomized, double-blind clinical trial, Vahdatpour et al. (2018) evaluated the efficacy of ESWT on pain and American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Reinfoot scale score in patients with chronic TA. A total of 43 patients with chronic TA were selected and randomized into 2 groups to receive initial treatment with either ESWT or sham SWT (radial and focused shockwaves, 4r sessions once a week for 4 weeks); AOFAS and pain scores for each patient were recorded at baseline (before the intervention), immediately after the intervention, and at 4 and 16 weeks after the intervention using the AOFAS scale method and the visual analogue scale (VAS). A total of 43 patients (22 TOCH and 21 sham SWT) participated in this study. Both groups improved during the treatment and follow-up periods. The mean VAS score decreased from 7.55 to 3 in the intervention group and from 7.70 to 4.30 in the sham SWT group. Mean AOFAS and VAS scores were significantly different between the ESWT and non-ESWT groups at the 16-week follow-up (p=0.013) (p=0.47). At the other follow-up times, there was no significant difference between the two groups regarding the AOFAS and VAS scores. The authors concluded that ESWT resulted in a decrease in VAS score and an increase in AOFAS score. However, these researchers stated that the results were not statistically significant due to the small sample size; stated that further intervention studies with a larger sample size are needed.
Additionally, an UpToDate review of “Achilles Tendinopathy and Tendon Rupture” (Maughan & Boggess, 2020) states that “Extracorporeal shock wave therapy (ESWT) uses pressurized air or electromagnetic pulses to deliver shock waves and is used as an adjunctive treatment for a variety of chronic diseases. Disorders A systematic review of the effectiveness of ESWT in common disorders of the lower extremities found only weak evidence for the use of ESWT in Achilles tendonitis. There is evidence that ESWT may be comparable to eccentric training but superior to observational waiting at four months and superior to eccentric training at four months but less effective than short-term glucocorticoid therapy in the treatment of Achilles tendinopathies medium. Treatment of Insertion Achilles Tendinopathy”; ESWT is not included in the "Summary and Recommendations" of this review.
Pinitkwamdee and colleagues (2020) stated that ESWT was proposed as a conservative treatment for Achilles tendon insertion tendinopathy (ATI) based on limited evidence without placebo controls. In a randomized, double-blind, sham-controlled study, these investigators evaluated the effectiveness of ESWT versus sham controls in the treatment of chronic TAI. This study was carried out between 2016 and 2018. Inclusion criteria were patients aged 18 to 70 years with a diagnosis of chronic TIA and failure of standard conservative treatment. After computer-assisted randomization, patients were assigned to low-energy ESWT or a sham control. Pain, function, and other symptoms were assessed using VAS and ankle-foot VAS (VAS-FA) before surgery and at weeks 2, 3, 4, 6, 12, and 24. Intent-to-treat analysis (ITT) and repeated measures were performed using STATA 15.0. A total of 16 patients in the ESWT and 15 patients in the sham control groups had non-significantly different baseline characteristics with pre-intervention VAS (6.0 ± 2.6 vs. 5.2 ± 2.2) and VAS-FA (64 .8 ±16.6 vs. 65.3 ± 12.7). There was no significant difference in VAS, VAS-FA and their long-term domains between the two groups. Furthermore, the ESWT group had a significant improvement in VAS (2.9 ± 2.2) at weeks 4 to 12 and the sham control group had a significant improvement in VAS (2.3 ± 2.6) at weeks 12 to 24. Complications were observed only after ESBT treatment. The authors concluded that at 24 weeks there was no difference in the use of low-energy ESWT for chronic ATI, particularly in elderly patients. However, it can provide a short therapeutic effect of 4 to 12 weeks Level of Evidence = I.
Zhi et al (2021) IAT is difficult to manage and there is no definitive consensus on which non-surgical treatment is superior to others. In a systematic review, these investigators reviewed the available evidence for a specific non-surgical treatment for IAT. Literature searches in PubMed, Embase, and Web of Science databases were performed from inception through October 2020. Results were independently reviewed by 2 reviewers and assessed according to inclusion/exclusion criteria. All included articles were checked for methodological quality and study characteristics were extracted. A total of 23 studies (with 35 groups) were eligible for the final review. Treatments included eccentric training, ESWT, injections, and combination treatments; VAS, Victorian Institute of Sport Assessment-Achilles questionnaire, AOFAS, satisfaction index, and other scales were used to examine clinical outcome. The authors concluded that although eccentric exercise supports more evidence supporting eccentric exercise than other interventions for moderate/non-insertive Achilles tendinitis, eccentric exercise did not result in a high satisfaction rate for a specific non-surgical treatment of TAI . Current evidence supports ESWT or the combined treatment of ESWT plus eccentric exercise.
The authors noted that one of the main disadvantages of this review was the low level of evidence and risk of bias in the included studies; only 6 studies were RCTs. Many studies have evaluated treatment outcome using patient-based self-comparison (before and after therapy), and a sham/control group (wait and see) is needed to truly and accurately reflect efficacy. Second, Achilles tendon pathology terminology varies between studies, so some studies may be excluded due to strict inclusion criteria during the literature review process. Third, in some studies, the diagnosis was based only on clinical findings without imaging confirmation, which may expand the scope of included cases or increase the risk of bias.
Mansur and colleagues (2021) noted that there is still a lack of consensus on the treatment of IAT. The condition is usually treated with eccentric exercises, although satisfactory and lasting results are not achieved. Shock wave therapy was presented as an alternative; However, there is a dearth of literature with good results supporting its use. In a single-centre, randomized, double-blind, placebo-controlled study, these investigators investigated whether the use of shockwave therapy combined with eccentric exercise could improve pain and function in patients with IAT. From February 2017 to February 2019, a total of 119 patients were evaluated and included in the study. 🇧🇷 Three sessions of radial shock waves (or sham treatment) were performed every 2 weeks and eccentric exercises were performed for 3 months. The primary outcome was the Victorian Institute of Sport Assessment-Achilles (VISA-A) questionnaire at 24 weeks; Secondary endpoints included VAS, algometry, foot and ankle outcome scores, and a 12-item short-form health survey. Both groups showed significant improvement during the study period; however, there were no differences between groups in any of the outcomes (all p > 0.05). At the 24-week assessment, the ESBT group showed a mean VISA-A score of 63.2 (95% CI, 8.0) compared to 62.3 (95% CI, 6.9) in the control group (p= 0.876). There was a higher failure rate (38.3%) but a lower recurrence rate (17.0%) in the OCBT group compared with the control group (11.5% and 34.6%, respectively; p=0.002 ep=0.047). No complications were reported for either group. The authors concluded that TOCH does not potentiate the effects of eccentric strengthening in the treatment of IAT. Level of evidence = I
Hypertrophic hand scars from burns
Joo and colleagues (2020) stated that postburn hypertrophic scarring is a common complication of hand burns, often associated with impaired hand function. In a double-blind RCT, these investigators examined the effects of ESWT compared to sham therapy on hypertrophic scarring of the hand due to burns and its impact on hand function. Forty-eight patients with burns on the dominant right hand were included in this study. ESWT parameters were as follows: energy flux density 0.05 to 0.30 mJ/mm 2 ; frequency 4 Hz; 1,000 to 2,000 pulses/treatment; 4 treatments once a week for 4 weeks. Outcomes measured were as follows: a 10-point VAS pain score; Vancouver Scar Scale for scar vascularity, height, flexibility and pigmentation; measurement of scar thickness by US; Jebsen-Taylor hand function test; grip strength; Lose Pegboard Test; and the Michigan Hand Outcome Questionnaire. The change in score from baseline to posttreatment between the two groups was compared. ESWT improved pain score (p=0.001), scar thickness (p=0.018), scar vascularity (p=0.0015) and improved hand function (simulated map turning, p=0.02 ; picking up small objects, p = 0.004) . The other measured outcomes were not different between the two groups. The authors concluded that they identified a clinically beneficial effect of ESWT in promoting hand function, improving healing, and alleviating scar-related pain. This demonstrated the clinical utility of the ESWT intensity and frequency parameters used in this study. Furthermore, these investigators indicated that it is important to note that the optimal frequency and intensity of ESWT for the treatment of hypertrophic scars on the hands after a burn has yet to be determined; However, these results provided investigators with an opportunity to use ESWT because of its potential to improve the management and treatment of burn scarring on the hands after partial-thickness skin grafting.
The authors stated that the results of this study required careful interpretation of the data due to the small sample size (n = 48), the short follow-up time (6 months) and the lack of a detailed measurement of ROM in the affected hand. They indicated that future studies with a longer time period and more detailed analyzes are needed to confirm these results; More basic research into the mechanisms underlying the clinical effects of ESWT is needed to determine optimal parameters for the clinical management of hypertrophic scars.
Trapezio-myofascial pain syndrome / Pelvic-myofascial pain syndrome
In a systematic review and meta-analysis, Zhang et al. (2020) The effect of ESWT on pain and function in myofascial pain syndrome (MPS) of the trapezius muscle. We systematically searched PubMed, Embase, Web of Science, Physiotherapy Evidence Database and the Cochrane Central Register of Controlled Trials from their inception to September 2019; RCTs comparing the effects of ESWT on trapezius MPS were included in this review. Data on study participants, intervention, follow-up period, measurement time, and outcomes were extracted. The Physiotherapy Evidence Database scale and the Cochrane Collaboration Risk of Bias Assessment Tool were used to assess study quality and risk of bias. A total of 10 articles (n = 477 patients) met the selection criteria and were included in this study. Overall effectiveness was calculated using a meta-analysis method. Meta-analysis found that ESWT showed significant improvement in pain reduction compared to sham treatment with ESWT or US, but no significant effect compared to conventional treatments (dry needling, trigger point injection, laser therapy) in terms of intensity and pain index. neck disability (IND). The authors concluded that ESWT patients with MPS of the trapezius muscle appeared to benefit from pain relief. These researchers noted that ESWT may not be an ideal therapeutic modality to replace traditional therapies; however, it could serve as an additional therapeutic method to these treatments.
Yoo and colleagues (2020) stated that MPS is common in clinical settings and negatively affects the patient's daily life. Recently, ESWT has been used as one of the therapies for MPS. In a systematic review and meta-analysis, these investigators examined the current evidence for a short-term effect of ESWT on trapezius MPS. We searched PubMed, EMBASE, Web of Science, and the Cochrane Central Register of Controlled Trials from database inception to March 2019; 2 reviewers independently reviewed the articles, assessed methodological quality, and extracted data. The primary endpoint was post-intervention pain intensity; RCTs were conducted to investigate whether ESWT was used as the main treatment for MPS. All 5 studies reviewed in this meta-analysis were examined for changes in pain intensity. Compared with other treatments, ESWT focusing on MPS was more effective in reducing VAS scores (SMD = -0.48, 95% CI -0.74 to -0.22). The authors concluded that there is very little evidence that focused ESWT is effective for the short-term relief of neck pain in MPS. The limited sample size and low quality of these studies underscore and support the need for large-scale, high-quality placebo-controlled studies in this area.
The authors stated that this study had several drawbacks. First, only 5 studies were included in the meta-analysis. However, all included studies were RCTs and these investigators performed a risk of bias assessment to overcome this limitation. Second, these investigators examined only VAS to determine the effect of ESWT in the meta-analysis. Another RCT study with a different measure is needed. Third, this meta-analysis failed to provide the long-term effect (greater than 4 weeks) of ESWT. Furthermore, the characteristics of the 5 studies were similar in terms of gender and age; Therefore, no subgroup sensitivity analysis could be performed in this study. These investigators indicated that future RCTs should show the effect of ESWT on age and gender.
Furthermore, an UpToDate review of treating myofascial pelvic pain syndrome in women (Moynihan & Elkadry, 2020) does not mention ESWT as a management/therapy option.
Spasticity associated with cerebral palsy
Kim and colleagues (2019) noted that recent clinical trials were conducted to investigate the effectiveness of ESWT in patients with cerebral palsy. However, several studies have adopted different clinical scales, making it difficult to reach a definitive conclusion about the effectiveness of ESWT in reducing spasticity after cerebral palsy. In a meta-analysis, these investigators examined the effects of ESWT on reducing spasticity after ESWT use in patients with cerebral palsy. In accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement, these investigators searched Medline, Embase, Web of Science, Cochrane Central Register of Controlled Trials, and Scopus from their start dates to December 11, 2018. They included RCTs in all languages that used OCBT to improve spasticity in people with cerebral palsy. As a result, they evaluated measured spasticity using MAS ROM and baropodometric values. Two authors independently extracted and reviewed the data. Whenever possible, a meta-analysis was performed; otherwise, data were synthesized narratively. From a total of 206 articles, 16 manuscripts were selected and 5 were included in this meta-analysis. MAS grade as a primary endpoint was significantly improved after ESWT compared to the control group (MD -0.62, 95% CI -1.52 to -0.18); ROM after ESBT was also significantly improved compared to controls (MD 18.01, 95% CI 6.11 to 29.91). Baropodometric measurements showed a significant increase in foot contact area during walking (SMD: 29.00; 95% CI: 11.08 to 46.92), but no significant increase in peak pressure under the heel (MD: 15.12, 95% CI -1.85 to 32.10) immediately after ESWT. The authors concluded that no serious side effects were observed in any patient after ESBT. These researchers noted that ESWT could be a good alternative to existing therapeutic options aimed at reducing spasticity and improving ROM in patients with cerebral palsy to maintain a healthy lifestyle and normalize the spastic gait pattern. Furthermore, they indicated that greater standardization of treatment protocols, including treatment intervals and intensities, is needed and that long-term follow-up studies are needed to confirm these results.
Mihai et al. (2022) found that the complexity of spasticity requires ongoing efforts in terms of personalized treatments for patients and accurate management. In a systematic review, these investigators compared the effectiveness of ESWT with botulinum toxin type A (BoNT-A) in reducing spasticity in children and adults. An electronic search was performed on PubMed/Medline, Scopus, Ovid Medline(R) and the Google Scholar search engine. Publications from January 2010 to January 2021 published in English and available in full text were eligible for inclusion and were searched without country restrictions. The study was conducted according to PRISMA guidelines. A total of 5 studies were included in this systematic review. Two independent authors performed reference selection, data extraction, and risk of bias assessment. Methodological quality and risk of bias were determined using the PEDro scale. The primary outcome was the degree of spasticity assessed by MAS and/or MTS. Additional endpoints included active ROM (AROM), passive ROM (PROM), Fugl-Meyer Upper Extremity Assessment (UE-FMA), pain intensity assessed via VAS, Spasm Frequency Scale (SFS), ultrasound parameters, comparison between groups and rate response to treatment. The authors concluded that a positive effect on spasticity was found for both treatments: evidence showed that ESWT and BoNT-A reduced spasticity considering parameters such as MAS, MTS, AROM, PROM, EU-FMA, VAS and improved SFS after stroke in patients with multiple sclerosis (MS) and cerebral palsy (CP). Furthermore, these researchers stated that more research is needed to strengthen the evidence and that more appropriate study protocols are needed.
Hsiao and colleagues (2021) stated that diabetic nephropathy (DN) is a common complication of diabetes; Current treatments for ND do not include promoting podocyte protection. These investigators investigated the therapeutic effects of ESWT in combination with melatonin (Mel) in a DN mouse model. DN rats were treated with Honey (5 mg/kg) twice a week for 6 weeks and ESWT (0.13 mJ/mm2) once a week for 6 weeks. These investigators assessed urinary microalbumin, albumin/creatinine ratio (ACR), glomerular hypertrophy, glomerular fibrosis, podocyte markers (Wilm's tumor protein 1, synaptopodin, and nephrin), cell proliferation, cell survival, cell apoptosis, renal inflammation, and renal oxidative stress. . The ESWT regimen in combination with Honey significantly reduced urinary microalbumin excretion (3.3 ± 0.5 mg/dl, p<0.001), ACR (65.2 ± 8.3 mg/g, p<0.001), hypertrophy of glomerular fibrosis (3.1 ± 0.1 × 106 μm3 , p < 0.01) and glomerular fibrosis (0.9 ± 0.4 mRNA relative folding, p < 0.05). Furthermore, the ESWT regimen in combination with Mel significantly increased podocyte number (44.1 ± 5.0% synaptopodin area, p < 0.001). This was probably because Honey in combination with ESWT reduced nephritis (753 ± 46 pg/mg, p<0.01), renal oxidative stress (0.6 ± 0.04 relative density, p<0.05) and significantly reduced apoptosis (0.3 ± 0.03 relative density, p < 0.001) and also significantly increased cell proliferation (2.0 ± 0.2% area of proliferating cell nuclear antigen (PCNA), p < 0, 01), cell survival and nephrin levels (4.2 ± 0.4 ng/mL, p < 0.001). The authors concluded that Mel ESWT combined enhanced podocyte protection and enhanced kidney function in a DN mouse model. These researchers indicated that Honey combined with ESWT could serve as a new non-invasive and effective treatment for NP.
Digital ulcers in systemic sclerosis
Costedoat and colleagues (2021) noted that treating digital ulcers in systemic sclerosis (SS) is difficult. Although the 2017 European League Against Rheumatism (EULAR) guidelines clearly define the use of systemic therapies for digital ulcers, little is known about the effectiveness of locoregional treatments. In a systematic review, these investigators reviewed available evidence on locoregional therapies for digital ulcers; a total of 58 studies were included. Among the various locoregional treatments described, injections of fat cells and botulinum toxin have shown promising results in reducing pain and the number of digital ulcers. On the other hand, this review found that sympathectomy gave disappointing results with low efficacy rates and frequent recurrences. For other treatments such as hyperbaric oxygen therapy, phototherapy (ultraviolet A, UVA), low-level light therapy, intermittent compression, Waon therapy, ESWT, vitamin E gel, and topical dimethylsulfoxide, conflicting results o Limited published data reflect that low-level of evidence. The authors concluded that larger RCTs are needed to confirm the validity of promising techniques.
Daia and colleagues (2021) compared the effectiveness of radial ESWT and ultrasound (US) in adult patients with idiopathic scoliosis on pain, disability, and quality of life. A total of 48 patients with idiopathic scoliosis were randomized into 3 groups of 16: ESWT, ultrasound and control. Subjects were assessed for pain on admission (day 1) and discharge (day 14) using the VAS; for disabilities resulting from the use of the ODI; and for QOL, with the abbreviated form -36. Radial ESBT was more effective than ultrasound in reducing pain (p=0.004) and improving quality of life, providing patients with additional vitality (p=0.003) and emotional comfort (p=0.007). Both ESWT therapy (p = 0.001) and ultrasound (p = 0.003) were effective in reducing pain. In terms of disability, both treatments had similar effects (p=0.439). The authors concluded that radial ESWT was significantly more effective than ultrasound in reducing pain and increasing quality of life and bringing additional vitality and emotional comfort to the patient with idiopathic scoliosis. In terms of disability, both treatments had similar effects when associated with kinesiotherapy. Furthermore, these investigators stated that further studies with larger study groups and longer follow-up are needed to expand and confirm these preliminary results and to develop appropriate standardized protocols for this type of patient.
The authors stated that the main disadvantage of this study was the lack of a standard protocol for radial ESWT and ultrasound therapy in scoliosis. To your knowledge, this was one of the first studies in this field and the results looked promising. Another disadvantage was the short-term evaluation of the outcomes examined in the study.
bone marrow edema
Hauser et al. (2021) noted that ESWT has been used for several pathologies associated with bone marrow edema (BME); However, it is still unclear whether ESWT can be beneficial in the treatment of BME. In a systematic review, these investigators examined the effectiveness of ESWT for the treatment of BME. Medline was searched for relevant literature with no time restrictions. Both RCTs and non-RCTs were included. Case reports and conference abstracts were excluded. Titles and abstracts were checked; and full-text articles of included studies were retrieved. Data on the effect of ESWT on pain, function and BME area on magnetic resonance imaging (MRI) were extracted. Pain, function, and MRI outcomes improved in all studies, regardless of whether the study was randomized or non-randomized. This effect was consistent across multiple pathologies, including osteonecrosis of the femoral head, BME associated with osteoarthritis (OA) of the knee, Kienbock's disease, and osteitis pubis. Meta-analysis showed that pain (at 1 month: WMD = -2.23, 95% CI -2.58 to -1.88, p<0.0001; at 3 to 6 months: WMD = -1.72, 95% CI: -2.52 to -0.92, p<0.00001) and function (at 1 month: WMD = -1.59, 95% CI: -2.04 to -1.14, p < 0.0001, at 3 to 6 months: WMD = -2.06, 95% CI: -3.16 to -0.96 , p = 0.0002, at 12 months or more: WMD = -1.20, 95% CI -1.83 to -0.56, p = 0.0002) was reduced for ESBT treatment compared to a control group. The authors concluded that, based on the available evidence, ESWT could be a viable option for conservative therapy in pathologies associated with SMB. Furthermore, these investigators indicated that more high-quality randomized trials with clear homogeneity across study designs are needed to build on existing evidence for ESWT.
The authors stated that this review had several drawbacks. Many pathologies that show BME on MRI were included in this review; However, it was unclear whether the effects seen in these studies were applicable to the treatment of SMB in general. While the response to ESWT looks good, it's unknown if BME might be behaving differently at some points. These investigators stated that future studies need to show the effects of ESWT treatment on pathologies not examined in the reviewed literature. This systematic review found very little high-quality evidence on the treatment of SMB with ESBT. Overall, there were only 2 RCTs and 4 prospective non-randomized studies, and overall heterogeneity was high; So, while the overall results were quite favorable across all types of studies, the overall level of evidence was weak.
Chronic obstructive pulmonary disease
Di Stefano et al. (2020) found that chronic obstructive pulmonary disease (COPD) is due to structural changes and narrowing of the small airways and parenchymal destruction (alveolar junction loss secondary to pulmonary emphysema), resulting in airflow restriction. Extracorporeal shock waves (ESW) increase cell proliferation and differentiation of connective tissue fibroblasts. Currently, there are no studies on ESW treatment of human bronchial fibroblasts and epithelial cells from patients and controls with COPD. These investigators obtained primary bronchial fibroblasts from bronchial biopsies from 3 patients with mild/moderate COPD and 3 control smokers with normal lung function; and human bronchial epidermal cells (16HBE) were also examined. Cells were treated with a low energy piezoelectric shock wave generator (0.3 mJ/mm², 500 pulses). After treatment, viability was assessed and cells were recultured and followed for 4, 24, 48 and 72 hours. Cell growth was assessed (WST-1 assay) and proliferation markers analyzed by qRT-PCR on cell lysates and by ELISA assays on cell supernatants and cell lysates. After ESW treatment, these investigators observed a significant increase in cell proliferation in all cell types. C-Kit mRNA (CD117) increased significantly in 16HBE cells after 4 hours. Protein levels were significantly increased for c-Kit (CD117) at 4 hours in 16HBE (p<0.0001) and at 24 hours in COPD fibroblasts (p=0.037); for PCNA at 4 hours in 16HBE (p=0.046); for Thy1 (CD90) at 24 and 72 hours in CS fibroblasts (p=0.031 and p=0.041); for TGFβ1 after 72 hours in CS fibroblasts (p=0.038); for procollagen-1 after 4 hours in fibroblasts with COPD (p=0.020); and for NF-κB-p65 at 4 and 24 hours in 16HBE (p=0.015 and p=0.0002). Type II alveolar epithelial cells (TTF-1+) co-expressing c-Kit (CD117) and PCNA were occasionally observed in the peripheral lung tissue of a representative COPD patient. The authors concluded that these results demonstrated increased cell proliferation induced by low-dose ESW in 16HBE cells and primary bronchial fibroblasts from COPD patients and smoking controls.
Furthermore, an UpToDate review on Management of Refractory Chronic Obstructive Pulmonary Disease (Ferguson and Make, 2022) does not mention ESWT as a management/therapy option.
In a systematic review and meta-analysis, Karanasios et al. (2021) the effectiveness of ESWT compared to other interventions on pain, grip strength, and disability in patients with lateral elbow tendinopathy. Data sources included Medline, PubMed, CINAHL, Embase, PEDro, ScienceDirect, Cochrane Library, and clinical trial registries. These investigators included RCTs that evaluated the effectiveness of ESWT alone or as an additional intervention compared with simulation or other interventions. Pain intensity, grip strength, and elbow disability were used as primary outcomes. They assessed methodological quality using the PEDro score and quality of evidence using the GRADE approach. Finally, a total of 27 studies involving 1871 patients were included; TOCH reduced pain intensity at medium-term follow-up (SMD: -1.21, 95% CI: -1.53 to -0.89, p<0.001) and improved grip strength at very short-term (MD: 3.92, 95% CI: 0.91 to 6.94, p=0.01) and short-term follow-up (MD: 4.87, 95% CI: 2.24 to 7.50, p<0.001) compared to sham therapy. However, no clinically significant results between comparators were found for all outcomes and follow-up times. ESWT was clinically better than laser for short-term grip strength (MD 3.50, 95% CI 2.40 to 4.60, p<0.001) and ultrasound for pain intensity at very short follow-up (SMD:- 1.54), 95% CI: -2.60 to -0.48, p=0.005). The authors concluded that the low-to-moderate certainty evidence suggests that there is no clinical benefit from ESWT compared with sham interventions or corticosteroid injections. Based on a very low and moderate level of evidence, ESBT outperformed laser and ultrasound, respectively. Level of evidence = Ia.
Bakr and El-Sakka (2021) found that PD is associated with penile pain, deviation, and sexual dysfunction. To date, there is no standard conservative treatment for Parkinson's disease; However, the role of ESWT is gaining increasing interest. In a systematic review and meta-analysis, these investigators examined the effect of ESWT on penile deviation, plaque size, erectile function, pain score, and complication rate in patients with Parkinson's disease. We searched the PubMed database for articles published from January 2000 to November 2020 using related keywords and including RCTs only. Meta-analyses and forest plots were performed using RevMan and the results were independently reviewed by two authors. In this study, the PRISMA guidelines were used to perform the quantitative and qualitative synthesis of the data. Outcome measures included changes in penile deviation, plaque size, erectile function, pain score, and rate of ESWT-related complications. The search returned 73 items; 3 RCTs were reviewed, including 117 patients in the ESWT group and 121 patients in the placebo group. TOCH was associated with a reduction in plaque size (OR=2.59, 95% CI 1.15 to 5.85, p=0.02). No significant difference in reduction of penile deflection angle or bruising rate was observed in the post-ESWT group compared to placebo. No evidence of an effect of ESWT on erectile function or pain scales was found. Based on available RCTs, ESWT failed to improve penile curvature or pain in men with Parkinson's disease. Although ESWT can reduce plaque size, this remains of questionable clinical importance. The authors concluded that available evidence suggests that ESWT does not improve penile curvature and pain in men with Parkinson's disease. Although ESWT can reduce plaque size, this remains of questionable clinical significance and further studies are needed to confirm these results.
The authors stated that the main drawbacks of this study were that the included RCTs used different metrics to report the same outcome; missing data were imputed to meet meta-analysis requirements; and there were still many dates which could not be estimated.
spinal cord injury
Alavi et al. (2021) noted that, as there is no consensus on the effectiveness of ESWT in the treatment of SCI complications, this meta-analysis examined the preclinical evidence in this regard. The search strategy was developed based on keywords related to “spinal cord injury” and “extracorporeal shock wave therapy”. A primary search of Medline, Embase, Scopus, and Web of Science was performed through the end of 2020. Studies that administered ESWT in animal models of SCI and evaluated motor function and/or histological findings were included. SMDs were calculated with a 95% CI. A total of 7 articles were included. Locomotion improved significantly in the ESWT group (SMD 1.68, 95% CI 1.05 to 2.31, p=0.032). ESWT efficacy was greater than 0.04 mJ/mm2 at an energy flux density of 0.1 mJ/mm2 (p = 0.044). Shockwave therapy was found to improve axonal growth (SMD 1.31, 95% CI 0.65 to 1.96), tissue levels of vascular endothelial growth factor (VEGF) (SMD 1.36, 95% CI 0.54 to 2.18) and increases cell survival (SMD 2.49, 95%). CI 0.93 to 4.04). It also significantly prevented axonal degeneration (SMD 2.25, 95% CI 1.47 to 3.02). The authors concluded that ESWT significantly improved locomotor recovery in animal models of SCI through neural tissue regeneration. However, despite the promising results and clinical application of ESWT in various diseases, current evidence suggests that the design of clinical trials of ESWT for the treatment of SCI may not be early; Therefore, more preclinical studies are needed to reach the safest and most efficient treatment protocol.
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Is extracorporeal shock wave therapy FDA-approved? ›
Shockwave therapy is still a procedure that is not FDA-approved. Some of the benefits of shockwave therapy, such as improvement of blood flow and improvement of connective tissue damage are FDA-approved indications.Is ESWT legit? ›
Extracorporeal shock wave therapy (ESWT) is a safe therapy and there are only a few side effects known (such as pain during ESWT and minor haematomata), but no severe complications are to be expected if it is performed as recommended.Why is shock wave therapy not approved in United States? ›
In the absence of clinical trials showing its long-term effectiveness, SWT has not been approved by the FDA for treatment of ED and is not covered by insurance. In its guidelines for ED treatment, the AUA designates SWT as an "investigational" treatment that should be limited to research trials.What is the appropriate code for single musculoskeletal shockwave therapy? ›
6A930ZZ Shock Wave Therapy, Musculoskeletal, Single - ICD-10-PCS Procedure Codes.Is extracorporeal shock wave therapy covered by insurance? ›
Commercial insurance plans do not cover the cost of treatment with shockwave therapy for ED. No clinics that offer shockwave therapy for ED including those that offer Gainswave therapy branded shockwave therapy, CoreWave branded shockwave therapy and Rajavapulse, are covered by health insurance plans.When was electro shock therapy banned? ›
Alleged Internet addiction (or general unruliness) in adolescents is also known to have been treated with ECT, sometimes without anestheia, most notably by Yang Yongxin. The practice was banned in 2009 after news on Yang broke out.Can ESWT cause damage? ›
It is abundantly clear that Shockwave can do serious damage to tissues as well as local circulation. Employing Shockwave therapy too close to open or post surgical wounds could lead to not only degradation of the wound, but also further bleeding as well as delayed healing.How much does ESWT therapy cost? ›
Shockwave costs $200 to $500 per treatment depending of the area treated. If your insurance doesn't cover the cost, an office visit—where you will be diagnosed and the doctor will determine whether or not Shockwave is right for you—will incur a regular doctor visit fee, separate from the Shockwave fee.What is the success rate of shockwave therapy? ›
Current Shockwave Research
Double-blind, randomized, controlled studies, indicate up to 91% improvement with 84% success rate for numerous conditions. Shockwave therapy is a proven effective treatment supported by medical literature.
If you have a blood clotting disorder (including thrombosis) If you are taking oral anti-coagulants. If you have received a Steroid injection within 6 weeks. If you have a Pacemaker fitted.
When should you not use Shockwave? ›
This type of treatment isn't suitable if: You have a blood clotting disorder and/or take blood thinning or anticoagulant medications such as aspirin (75mg on a daily basis) or warfarin. You have a nerve disorder. You're pregnant.Is electro shock therapy still used today? ›
People who can't take medications for mental health conditions for any reason can often still receive ECT. This can make a big difference for people with organ function problems or people who are pregnant (ECT is safe during all three trimesters of pregnancy). It's especially effective in combination with medication.What are the CPT guidelines for the musculoskeletal system? ›
Surgical Procedures on the Musculoskeletal System CPT® Code range 20100- 29999. The Current Procedural Terminology (CPT) code range for Surgical Procedures on the Musculoskeletal System 20100-29999 is a medical code set maintained by the American Medical Association.What is the CPT code for shockwave therapy? ›
|0101T||EXTRACORPOREAL SHOCK WAVE INVOLVING MUSCULOSKELETAL SYSTEM, NOT OTHERWISE SPECIFIED|
|0102T||EXTRACORPOREAL SHOCK WAVE PERFORMED BY A PHYSICIAN, REQUIRING ANESTHESIA OTHER THAN LOCAL, AND INVOLVING THE LATERAL HUMERAL EPICONDYLE|
Shockwave therapy is a modality that is becoming more common in physiotherapy.Is ESWT the same as tens? ›
While TENS therapy and ESWT therapy (extracorporeal shock wave therapy) might seem similar, since they both use electrical currents, the two procedures are different in several ways.Does insurance cover electromagnetic stimulation? ›
Most insurance companies will only cover medically necessary services or procedures. Transcranial Magnetic Stimulation (TMS) therapy is now considered medically necessary for the treatment of depression and is therefore covered by many policies.How long does ESWT last? ›
Extracorporeal Shock Wave Therapy or ESWT is an 18-minute non-surgical procedure used to cure chronic plantar fasciitis, Achilles tendonitis, tennis elbow, shoulder tendonitis, and other chronic tendinopathies.Why is ECT so controversial? ›
Reasons for Controversy
Three reasons are given for the aversion: 1) ECT is considered old-fashioned and politically incorrect; 2) it is forced on the patient; and 3) the memory disturbances are so severe and persistent that no rational human being would undergo this procedure, no matter how well-intended.
However, peer-reviewed research published in the journal Ethical Human Psychology and Psychiatry concludes "the high risk of permanent memory loss and the small mortality risk means that its use should be immediately suspended".
What is electro shock therapy called now? ›
Electroconvulsive therapy (ECT)Can shockwave therapy damage bones? ›
Many studies reported intensive osteochondrogenesis in segmental femoral defects after shockwave treatment, but no shockwave-induced crack or micro-damage was noted on bone , , .Are there side effects from shockwave therapy? ›
Side effects from ESWT are limited to mild bruising, swelling, pain, numbness or tingling in the treated area, and the recovery is minimal compared with that of surgical intervention. "Most patients take a day or two off after treatment but don't require a prolonged recovery period," says Dr. Finnoff.Why is shock wave therapy so painful? ›
The reason is that shock waves cause micro-traumas and bursting of microtissues (bone, tendons, and muscles) in order to generate blood flow and stimulate cell regeneration. Then, both traumas and recovering tissues might be the responsible for the engendered pain.How long does it take for ESWT to work? ›
Most people who get shockwave therapy for ED will often see benefits within one to three months. The initial results (within the first several weeks) can be dramatic.Does shockwave therapy reduce inflammation? ›
Shockwave therapy can help reduce inflammation, swelling, and pain by decreasing the release of inflammatory mediators from cells in the treated area. The sound waves cause tiny vibrations in the tissue, which help to break up the inflammatory cells and promote healing.How long does it take to heal after shockwave therapy? ›
After the treatment sessions are completed the injured area will continue to heal for 6-12 weeks with maximal recovery occurring approximately 3 months after the treatment sessions end.What should you not do after shockwave therapy? ›
After the procedure, it is best to avoid anti-inflammatory medications, such as Advil because stimulating the inflammation cascade is part of the healing process activated by ESWT. Other than that, you can go about your normal activities, generally including exercise if you feel up to it.Can shockwave therapy help tight muscles? ›
Normalizes Muscle Tone – SWT also works to relax muscle contractions and prevents neuro-cognitive pain associated with chronic conditions. As a result, it can normalize muscle tone and relieve spasms.Does shockwave therapy Help Arthritis? ›
While there is no cure for it, shockwave therapy offers a remedy for arthritis in the knee to reduce pain and improve function. Shockwave therapy can accelerate the body's healing process through acoustic pressure waves that boost metabolism and blood circulation.
Is shockwave therapy good for sciatica? ›
However, alternative treatments have been suggested in countering the debilitating effects of pain in the sciatic nerve. Shockwave therapy has proven to be an effective treatment for pain from nerve damage and leads to a strengthening of muscles and tendons.Can I take ibuprofen before shockwave therapy? ›
How can I prepare for ESWT? You will need to be available for the full course of treatment. You should not take any non-steroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen, for two weeks before your first procedure, and throughout your treatment.What are some of the pros and cons of shock therapy? ›
The Pros & Cons Of ECT
First and foremost, the treatment requires sedation, making recovery complex and much longer. Second, ECT has a higher chance to cause serious side effects for some individuals, including memory loss, which can deter potential patients. Pros of ECT: Safer today than previous ECT treatments.
EPAT Therapy for neuropathy has shown to be very effective for speeding up the healing process and reducing pain more quickly than other methods. It is also commonly known as Shockwave Therapy.Can you use shockwave therapy for the spine? ›
ESWT for the treatment of pain secondary to heterotopic ossification due to spinal cord injury was found to be effective through continued use of ESWT, as indicated by decreased VAS scores reported by patients and decreased NHO measurements.Is shockwave therapy good for back pain? ›
There are a number of studies that show that shockwave therapy is an effective treatment for back pain. One study has shown that an exercise program combined with shockwave therapy relieves chronic back pain more than an exercise program combined with conservative physical therapy.Does ECT cause permanent damage? ›
ECT can cause severe and permanent memory loss, brain damage, suicide, cardiovascular complications, intellectual impairment and even death. As of early 2017, the WA Chief Psychiatrist's ECT Guidelines recommended ECT consent form, states: “In some people, memory loss may be severe and can even be permanent.”What ECT does to the brain? ›
WHAT IS ECT? During ECT, a small amount of electrical current is passed through the brain while the patient is under general anesthesia. This current causes a seizure that affects the entire brain, including the parts that control mood, appetite, and sleep.What medications should be stopped before ECT? ›
There are reports of certain complementary medications such as ginkgo biloba, ginseng, St John's wort, valerian and kava kava interfering with ECT. 35 Given the lack of evidence of efficacy of these medications, it is advisable to cease these supplements prior to commencement of ECT as the risks outweigh the benefits.What are the 6 P's of musculoskeletal assessment? ›
The six P's include: (1) Pain, (2) Poikilothermia, (3) Paresthesia, (4) Paralysis, (5) Pulselessness, and (6) Pallor.
What 3 techniques are used during a musculoskeletal assessment? ›
To perform an examination of the muscles, bones, and joints, use the classic techniques of inspection, palpation, and manipulation.What is the difference between CPT code 28730 and 28740? ›
For example, CPT 28740 is for fusion of a single midtarsal or tarsometatarsal joint. There is also CPT 28730 for fusion of multiple (or transverse) midtarsal or tarsometatarsal joints.What is the code for single musculoskeletal shockwave therapy? ›
6A930ZZ Shock Wave Therapy, Musculoskeletal, Single - ICD-10-PCS Procedure Codes.Is shockwave therapy FDA-approved? ›
Shockwave therapy is still a procedure that is not FDA-approved. Some of the benefits of shockwave therapy, such as improvement of blood flow and improvement of connective tissue damage are FDA-approved indications.Is shockwave therapy legitimate? ›
Shockwave therapy has proven to be effective in treating some medical conditions. While it isn't currently an FDA-approved treatment for ED, some doctors use it off-label for ED.Is ECT therapy FDA approved? ›
Overall, the FDA order allows patients who need and want ECT, as well as practitioners who perform it, to breathe a sigh of relief.What stem cell therapies are FDA approved? ›
- ABECMA (idecabtagene vicleucel) ...
- ALLOCORD (HPC, Cord Blood) ...
- BREYANZI. ...
- CARVYKTI (ciltacabtagene autoleucel) ...
- CLEVECORD (HPC Cord Blood) ...
- Ducord, HPC Cord Blood. ...
- GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) ...
- HEMACORD (HPC, cord blood)
- ALLOCORD (HPC, Cord Blood), SSM Cardinal Glennon Children's Medical Center. ...
- BREYANZI. ...
- CLEVECORD (HPC Cord Blood), Cleveland Cord Blood Center. ...
- Ducord, HPC Cord Blood, Duke Med School, Similar to ALLOCORD.
Currently, the only stem cell treatments approved by the Food and Drug Administration (FDA) are products that treat certain cancers and disorders of the blood and immune system.Who is ECT Not recommended for? ›
Not everyone is a candidate for treatment even if they believe ECT could help them. For example, children under age eleven cannot undergo ECT for mental health disorders. People with heart conditions and people who cannot handle short-acting sedatives or muscle relaxers should not undergo ECT treatments.
Who is a candidate for ECT therapy? ›
Electroconvulsive therapy (ECT) is a medical treatment most commonly used in patients with severe major depression or bipolar disorder that has not responded to other treatments.Do doctors still use ECT? ›
People who can't take medications for mental health conditions for any reason can often still receive ECT. This can make a big difference for people with organ function problems or people who are pregnant (ECT is safe during all three trimesters of pregnancy). It's especially effective in combination with medication.Does insurance cover stem cell therapy 2022? ›
In general, stem cell treatment procedures are paid out-of-pocket by patients, because they are not covered by medical insurance. The cost of platelet rich therapy (PRP), which can be used separately or in conjunction with stem cell therapy, is typically $500-700, but may be as high as $2,000 at some locations.Do most insurance companies cover stem cell therapy? ›
“Are stem cell therapies covered by insurance?” The short answer is no, but there are instances where there may be some kind of coverage.Why is stem cell treatment not allowed in the US? ›
Under FDA regulations, most stem cell treatments being sold to customers are illegal. That's because the products are deemed to be unlicensed drugs.What are the 4 FDA approved gene therapies? ›
Beta thalassemia gene therapy (Zynteglo®) CAR T-cell therapy (KYMRIAH™) for relapsed or treatment-resistant leukemia and lymphoma. Luxturna™ gene therapy for inherited retinal disorder. SKYSONA® gene therapy for cerebral adrenoleukodystrophy (CALD)What are the 4 types of stem cell therapy? ›
ASCs: Types and Use in Cell Therapy
ASCs include hematopoietic stem cells (HSCs), skin stem cells (SSCs), neural stem cells (NSCs), and mesenchymal stem cells (MSCs) (62).
Unfortunately, non-surgical stem cell therapy and PRP injections are not covered because insurance companies consider it to be “experimental” based on what seems to be a lack of evidence on certain procedures by the FDA.Why stem cell treatment is still controversial? ›
Opponents argue that the research is unethical, because deriving the stem cells destroys the blastocyst, an unimplanted human embryo at the sixth to eighth day of development. As Bush declared when he vetoed last year's stem cell bill, the federal government should not support “the taking of innocent human life.”Is stem cell therapy bogus? ›
But a word to the wise: there's a lot of false and misleading information out there, including what some promoters are saying about stem cell therapy. The truth is, stem cell products have not been shown to be safe or effective for most ailments, and could actually be harmful.
What states banned stem cell research? ›
One group of states prohibited human reproductive cloning without otherwise limiting stem cell research. This group includes California, Connecticut, Illinois, Maryland, Massachusetts, New Jersey, New York, Missouri, and Rhode Island.