Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions
Extracorporeal shock wave therapy (ESWT), using either a high- or low-dose protocol or radial ESWT, is considered investigational as a treatment of musculoskeletal conditions, including but not limited to plantar fasciitis; tendinopathies including tendinitis of the shoulder, tendinitis of the elbow (lateral epicondylitis), Achilles tendinitis, and patellar tendinitis; spasticity; stress fractures; delayed union and non-union of fractures and avascular necrosis of the femoral head.
Note: High-energy ESWT requires the use of anesthesia and is performed in a hospital or ambulatory surgery center. Low-energy ESWT is usually used in the office without anesthesia.
Extracorporeal shock wave therapy (ESWT) is a noninvasive method that may be used to treat pain using shock waves or sound waves that are directed from outside the body onto the area to be treated, e.g., the heel in the case of plantar fasciitis. Shock waves may be generated at high- or low -energy intensity, and treatment protocols may include more than one treatment.
ESWT, also known as orthotripsy, has been available since the early 1980s for the treatment of renal stones and has been widely investigated for the treatment of biliary stones. ESWT uses externally-applied Shock waves to create a transient pressure disturbance, which disrupts solid structures, breaking them into smaller fragments, thus allowing spontaneous passage and/or removal of stones. The mechanism by which ESWT might have an effect on musculoskeletal conditions is not well -defined. Chronic musculoskeletal conditions, such as tendinitis, can be associated with a substantial degree of scarring and calcium deposition. Calcium deposits may restrict motion and encroach on other structures, such as nerves and blood vessels, causing pain and decreased function. One hypothesis is that disruption of these calcific deposits by shock waves may loosen adjacent structures and promote resorption of calcium, thereby decreasing pain and improving function.
Other mechanisms are also thought to be involved in the mechanism of ESWT. Physical stimuli are known to activate endogenous pain control systems, and activation by shock waves may “reset” the endogenous pain receptors. Damage to endothelial tissue from ESWT may result in increased vessel wall permeability, causing increased diffusion of cytokines, which may in turn promote healing. Microtrauma induced by ESWT may promote angiogenesis and thus aid in healing. Finally, shock waves have been shown to stimulate osteogenesis and promote callous formation in animals, which is the rationale for trials of ESWT in delayed union or non-union of bone fractures.
Plantar fasciitis is a very common ailment characterized by deep pain in the plantar aspect of the heel, particularly on arising from bed. While the pain may subside with activity, in some patients the pain may persist, interrupting activities of daily living. On physical examination, firm pressure will elicit a tender spot over the medial tubercle of the calcaneus. The exact etiology of plantar fasciitis is unclear, although repetitive injury is suspected. Heel spurs are a common associated finding, although it has never been proven that heel spurs cause the pain and asymptomatic heel spurs can be found in up to 10% of the population. Most cases of plantar fasciitis are treated with conservative therapy, including rest or minimization of running and jumping, heel cups, and nonsteroidal-anti-inflammatory drugs. Local steroid injection may also be used. Improvement may take up to 1 year in some cases.
Tendinitis and Tendinopathies
ESWT has been investigated for a variety of tendinitis/tendinopathy syndromes. Some of the more common tendinitis syndromes are summarized in Table 1. Many tendinitis/tendinopathy syndromes are related to overuse injury. Conservative treatment often involves rest, activity modifications, physical therapy, and anti-inflammatory medications.
Table 1: Tendinitis/Tendinopathy Syndromes
NSAIDs: nonsteroidal anti-inflammatory drugs.
Fracture Nonunion and Delayed Union
The definition of a fracture nonunion has remained controversial, particularly in the necessary duration to define a condition of nonunion. One proposed definition is failure of progression of fracture-healing for at least 3 consecutive months (and at least 6 months following the fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing). For purposes of policy development, the following criteria have been used to define nonunion:
Delayed union refers to a decelerating bone healing process, as identified in serial radiographs. (In contrast, nonunion serial radiographs show no evidence of healing.) Delayed union can be defined as a decelerating healing process, as determined by serial radiographs, together with a lack of clinical and radiologic evidence of union, bony continuity, or bone reaction at the fracture site for no less than 3 months from the index injury or the most recent intervention.
Other Musculoskeletal and Neurologic Conditions
ESWT has been investigated for a variety of other musculoskeletal conditions, including medial tibial stress syndrome, osteonecrosis (avascular necrosis) of the femoral head, coccydynia, and painful stump neuromas.
Spasticity refers to a motor disorder characterized by increased velocity-dependent stretch reflexes. It is one characteristic of upper motor neuron dysfunction, which may be due to a variety of pathologies.
Currently, 5 ESWT devices for orthopedic use are approved for marketing by FDA and are summarized in Table 2. FDA product code: NBN.
Table 2: FDA-Approved Extracorporeal Shock Wave Therapy Devices
FDA: Food and Drug Administration.
Both high-dose and low-dose protocols have been investigated. A high-dose protocol consists of a single treatment of high-energy shock waves (1300 mJ/mm2). This painful procedure requires anesthesia. A low-dose protocol consists of multiple treatments, spaced 1 week to 1 month apart, in which a lower dose of shock waves is applied. This protocol does not require anesthesia.The FDA-labeled indication for the OssaTron® and Epos™ Ultra device specifically describes a high-dose protocol, while the labeled indication for the SONOCUR® device describes a low-dose protocol.
Another type of ESWT, radial ESWT (rESWT) received premarket approval in May 2007. The FDA-approved device is the Dolorclast from EMS Electro Medical Systems (Nyon, Switzerland). Radial ESWT is generated ballistically by accelerating a bullet to hit an applicator, which transforms the kinetic energy into radially expanding shock waves. Other types of ESWT produce focused shock waves that show deeper tissue penetration with significantly higher energies concentrated to a small focus. Radial ESWT is described as an alternative to focused ESWT and is said to address larger treatment areas, thus providing potential advantages in superficial applications like tendinopathies.
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This policy was created in 2001 based on a 2001 TEC Assessment that concluded that extracorporeal shock wave therapy (ESWT) met TEC criteria as a treatment for plantar fasciitis in patients who had not responded to conservative therapies. (1) Therefore, the 2001 medical policy stated that ESWT would be considered medically necessary in these patients. A 2003 TEC Assessment reviewed subsequently available literature on ESWT for musculoskeletal conditions with a focus on 3 conditions: plantar fasciitis, tendinitis of the shoulder, and tendinitis of the elbow. (2) The 2003 TEC Assessment came to different conclusions, specifically, that ESWT did not meet TEC criteria as a treatment of plantar fasciitis or other musculoskeletal conditions. Therefore, the policy statement was revised to indicate that ESWT is investigational. In October 2004, updated TEC Assessments were completed for plantar fasciitis and tendinitis of the elbow. (3, 4) The 2004 TEC Assessments concluded that ESWT did not meet TEC criteria for the treatment of these conditions. Since the 2004 TEC Assessments, the policy has been updated periodically with literature searches using the MEDLINE database. The most recent literature review covered the period through January 12, 2015. Following is a summary of key studies to date.
The most clinically relevant outcome measures of ESWT used for musculoskeletal conditions are pain and functional limitations. Pain is a subjective, patient-reported measure. Therefore, pain outcomes require quantifiable pre- and post-treatment measures. Pain is most commonly measured with a visual analog scale (VAS). Quantifiable pre- and post-treatment measures of functional status are also used, such as 12-Item Short -Form Health Survey (SF-12) and SF-36. Minor adverse effects of ESWT are common but transient, including local pain, discomfort, trauma, bleeding, and swelling. More serious adverse outcomes of ESWT may potentially include neurologic damage causing numbness or tingling, permanent vascular damage, or rupture of a tendon or other soft tissue structure.
Because of the variable natural history of plantar fasciitis and other musculoskeletal conditions and the subjective nature of the outcome measures, randomized controlled trials (RCTs) are needed to determine whether outcomes are improved with ESWT. Trials should include a homogenous population of patients with a defined clinical condition, use standardized outcome measures whenever possible, and define a priori the magnitude of response that is clinically significant.
ESWT for Plantar Fasciitis
Eight studies met the inclusion criteria for the 2004 TEC Assessment. (3) Five double-blind RCTs, reporting on 992 patients, were considered to be of high quality. Overall, evidence included in the 2004 TEC Assessment showed a statistically significant effect on between-group difference in morning pain measured on a 0 to 10 VAS score. Uncertain was the clinical significance of the change. The absolute value and effect size were small. The most complete information on the number needed to treat to achieve 50% to 60% reduction in morning pain was from 2 studies of high-energy ESWT (and including confidential data provided by Dornier), combined number needed to treat of 7 (95% confidence interval [CI], 4 to 15). Improvements in pain measures were not clearly associated with improvements in function. Effect size for improvement in pain with activity was nonsignificant, based on reporting for 81% of patients in all studies and 73% of patients in high-energy ESWT studies. Success in improvement in Roles and Maudsley (RM) score was reported for fewer than half the patients: although statistically significant, confidence intervals were wide. Where reported, improvement in morning pain was not accompanied by significant difference in quality-of-life measurement (SF-12 physical and mental Component Summary scores) or use in pain medication.
Systematic reviews and meta-analyses of RCTs published since the 2004 TEC Assessment have reported that ESWT for plantar fasciitis is better than or comparable with placebo in reducing pain (5-7) and improving functional status in the short-term. (5, 6) However, studies evaluated in these systematic reviews are subject to a number of limitations. Individual RCTs included in the reviews and meta-analyses reported inconsistent results and heterogeneity in the studies sometimes precluded meta-analysis of pooled data. Outcomes measured and study protocols, e.g., dose intensities, type of shockwaves and frequency of treatments, also often lacked uniformity. Additionally, given that plantar fasciitis often resolves within a 6-month period, longer follow-up studies are needed to compare ESWT results with the natural resolution of the condition. The clinical significance of results reported at shorter follow-up, such as 3 months, is uncertain.
In a 2014 systematic review and meta-analysis with more restrictive inclusion criteria, Yin et al. evaluated 7 RCTs or quasi-RCTs of ESWT for chronic (at least 6 months) recalcitrant plantar fasciitis. (8) For the primary outcome of treatment success rate, which was defined differently across the included studies, pooled analysis of the 5 trials (N=448 subjects) that evaluated low-intensity ESWT showed that ESWT was more likely than control to lead to treatment success (pooled risk ratio [RR], 1.69; 95% CI: 1.37 to 2.07; p<0.001). In pooled analysis of the 2 trials (N=105 subjects) that evaluated high-intensity ESWT, there was no difference between ESWT and control in treatment success. A strength of this analysis is restricting the population to patients with at least 6 months of symptoms, because this is a clinical population that is more difficult to treat and less likely to respond to interventions. However, a weakness of this study is the heterogeneity in the definition of “treatment success,” which makes interpreting the pooled analysis challenging.
Randomized Controlled Trials
Some of the representative RCTs trials included in the systematic reviews previously described are as follows.
In 2005, results were reported from U.S. Food and Drug Administration (FDA)‒regulated trials delivering ESWT with the Orthospec™, and Orbasone™ Pain Relief System. (9,10) In the RCT used to support the FDA-approval of Orthospec™, investigators conducted a multicenter, double-blind, sham-controlled trial that randomized 172 participants with chronic proximal plantar fasciitis failing conservative therapy to ESWT or sham treatments in a 2 to 1 ratio.10 At 3 months, the ESWT arm had less investigator-assessed pain with application of a pressure sensor (0.94 points lower on a 10-point VAS; 95% CI: 0.02 to 1.87). However, there was no difference in improvement in patient-assessed activity and function between ESWT and sham groups. In the RCT used to support the FDA-approval of Orbasone™, investigators conducted a multicenter, randomized, sham-controlled, double-blind trial in which 179 participants with chronic proximal plantar fasciitis were randomized to active or sham treatment. (9) At 3 months, both active and sham groups improved in patient-assessed pain on awakening (by 4.6 and 2.3 points, respectively, on a 10-point VAS; crude difference between groups at 3 months of 2.3; 95% CI: 1.5 to 3.3). While ESWT was associated with more rapid improvement (and statistically significant) in a mixed-effects regression model, insufficient details were provided to evaluate the analyses.
Gerdesmeyer et al reported a multicenter double-blind RCT of radial rESWT conducted for FDA premarket approval of the Dolorclast® from EMS Electro Medical Systems in 2008. (11) In this study, 252 patients were randomized, 129 to rESWT and 122 to sham treatment. The patients had heel pain for at least 6 months and failure of at least 2 nonpharmacologic and 2 pharmacologic treatments before entry into the study. Three treatments at weekly intervals were planned, and more than 90% of patients in each group had all 3 treatments. Outcome measures were composite heel pain (pain on first steps of the day, with activity and as measured with Dolormeter), change in individual VAS scores, and RM score measured at 12 weeks and 12 months. Success was defined as at least 60% improvement in 2 of 3 VAS scores or, if less pain reduction, then the patient had to be able to work and complete activities of daily living, had to be satisfied with the outcome of the treatment, and must not have required any other treatment to control heel pain. Secondary outcomes at 12 weeks included changes in RM score, SF-36 physical score component percent changes, SF-36 mental Component Summary score percent changes, investigator’s judgment of effectiveness, patient’s judgment of therapy concerning specific outcomes (e.g., presenting percent changes rather than actual results of measures); inadequate description of prior treatment (or intensity of treatment) provided before referral to the study; use of the composite outcome measure; and no data on the use of rescue medication. In addition, the clinical significance of changes (and relative changes) in outcome measures is uncertain from this publication. There are also questions about the adequacy of patient blinding regarding treatment.
Several smaller trials (~50 patients) show inconsistent results. (12-14)
One RCT compared ESWT with an active alternative, endoscopic plantar fasciotomy. (16) This study included 65 patients with refractory plantar fasciitis who had failed at least 3 lines of treatment in the preceding 6 months. Outcome measures were a 0 to 100 VAS of morning pain, the American Orthopaedic Foot and Ankle (AOFAS) Ankle-Hindfoot scale, and patient subjective assessment using the 4-item RM score. Over the course of 1-year follow-up, both groups improved significantly on each outcome parameter, and there were no significant differences between groups. The percent of patients achieving a least a 50% reduction in the AOFAS score was reported in 74% (25/34) of patients in the ESWT group compared with 68% (21/31) patients in the surgery group (p=0.79). Success rates at 1 year, defined as a patient-reported good or excellent outcome per the RM score, were reached in 70.6% (24/34) patients in the ESWT group compared with 77.4% (24/31) in the surgery group. At 2 years of follow-up, the percent reporting success was higher in the surgery group, with 80% (20/25) reporting a successful outcome versus 50% (13/26, p=0.03) in the ESWT group. Similarly, at 3 -year follow-up, the percent reporting success was 80% (20/25) in the surgery group compared with 48% (11/23) in the ESWT group (p=0.021).
Nonrandomized studies have also reported outcomes after ESWT for plantar fasciitis, (17) but given the availability of randomized trials, these studies do not provide additional evidence about ESWT’s efficacy compared with alternatives.
There are numerous RCTs, including several well-designed double-blinded RCTs, that evaluate ESWT for treatment of plantar fasciitis. The evidence is mixed, with some studies reporting a benefit and others not reporting a benefit. The reasons for this variability in the literature are not clear. In studies that report a benefit, the magnitude of effect on some or all of the outcomes is of uncertain clinical significance. Definitive, clinically meaningful treatment benefits at 3 months are not apparent, nor is it evident that the longer term disease natural history is altered with ESWT. As a result, it is not possible to conclude that ESWT improves outcomes for patients with plantar fasciitis.
ESWT for Tendinitis of the Elbow (Lateral Epicondylitis)
Six randomized, double-blinded, placebo-controlled trials enrolling 808 patients with lateral epicondylitis met the inclusion criteria for the 2004 TEC Assessment. (4) Four trials were rated “good” quality and are summarized next. Three trials used low-energy ESWT, and one used high-energy ESWT. Two trials reported positive effects on pain, one trial had mixed results, and another large sham-controlled study reported negative results with ESWT.
Other systematic reviews published since the 2004 TEC Assessment have come to similar conclusions. A 2005 Cochrane review concluded “there is ‘Platinum’ level evidence [the strongest level of evidence] that shock wave therapy provides little or no benefit in terms of pain and function in lateral elbow pain.” (22) A 2013 systematic review of electrophysical therapies for epicondylitis concluded that the evidence is conflicting on the short-term benefits of ESWT. (23) No evidence was found demonstrating any long-term benefits with ESWT over placebo for epicondylitis treatment.
Randomized Controlled Trials
Several RCTs on ESWT for lateral epicondylitis have been published since the 2004 TEC Assessment. In 2005, Pettrone and McCall reported results from a double-blind randomized trial conducted in 3 large orthopedic practices for 114 patients receiving either ESWT in a "focused" manner (2,000 impulses at 0.06 mJ/mm2 without local anesthesia) weekly for 3 weeks or placebo. (24) Randomization was maintained through 12 weeks, and benefit demonstrated with respect to a number of outcomes: pain, functional scale, and activity score. Pain assessed on the VAS (scaled here to 10 points) declined at 12 weeks in the treated group from 7.4 to 3.8; among placebo patients from 7.6 to 5.1. A reduction in Thomsen test pain of at least 50% was demonstrated in 60.7% of those treated compared with 29.3% in the placebo group. Mean improvement on a 10-point UEFS activity score was 2.4 for ESWT-treated patients compared with 1.4 in the placebo group—difference at 12 weeks of 0.9 (95% CI: 0.18 to 1.6). Although this study found benefit of ESWT for lateral epicondylitis over 12 weeks, the placebo group also improved significantly; whether the natural history of disease was altered is unclear.
In 2008, Staples et al. reported a double-blind controlled trial of ultrasound-guided ESWT for epicondylitis in 68 patients. (25) Patients were randomized to receive 3 ESWT treatments or 3 treatments at a subtherapeutic dose at weekly intervals. There were significant improvements in most of the 7 outcome measures for both groups over 6 months of follow-up and no between-group differences. The authors found little evidence to support use of ESWT for this indication.
At least 2 RCTs have compared ESWT with active comparators. Jeon et al. compared ESWT with steroid injection in 22 patients who presented with newly diagnosed epicondylitis. (26) Outcomes were assessed at 8 weeks post-treatment with the RM score, as well as the Nirschl score. Both groups showed significant improvement on each outcome measure at 8 weeks. The steroid injection group improved to a greater extent on the Nirschl score within the first 2 weeks, but changes were similar at longer time points. There were no differences between groups on the RM score. A second RCT compared ESWT with 2 active comparators. (27) This trial randomized 59 patients with lateral epicondylitis to ESWT, physical therapy, or a single corticosteroid injection. Outcome measures were a VAS for pain, grip strength and pinch strength by dynamometer, and ultrasound. The authors reported that the VAS pain score improved significantly in all 3 groups at 6 -month follow-up, but no between-group differences were recorded. There were no consistent changes reported on grip strength or on ultrasonography.
Nonrandomized observational studies have reported functional outcomes after ESWT for epicondylitis (28); however, these studies provided limited evidence about the comparative effectiveness of ESWT for lateral epicondylitis compared with other therapies.
The most direct evidence related to the use of ESWT to treat lateral epicondylitis comes from multiple small RCTs, which have not consistently shown outcome improvements beyond those seen in control groups with ESWT. The highest quality trials have tended to show no benefit, and systematic reviews have generally concluded that the evidence does not support a treatment benefit.
ESWT for Shoulder Tendinopathy
There are numerous small RCTs that have evaluated ESWT for shoulder tendinopathy, primarily calcific and non-calcific tendinopathy of the rotator cuff. In a 2013 systematic review and meta-analysis, Ioppolo et al. included 6 RCTs on ESWT compared with sham treatment or placebo for calcific shoulder tendinopathy. (29) Greater shoulder function and pain improvements were found at 6 months with ESWT over placebo. Most studies were considered to be low quality. Huisstede et al published a systematic review of RCTs in 2011 that included 17 RCTs of calcific (n=11) and non-calcific tendinopathy of the rotator cuff. (30) Moderate -quality evidence was found for the efficacy of ESWT versus placebo for calcific tendinopathy, but not for non-calcific tendinopathy. High-frequency ESWT was found to be more efficacious than low-frequency ESWT for calcific tendinopathy.
In 2014, Bannuru et al. published a systematic review of RCTs comparing high-energy ESWT with placebo or low-energy ESWT for the treatment of calcific or noncalcific shoulder tendinitis. (31) In 7 studies comparing ESWT with placebo for calcific tendinitis, all studies reported significant improvements in pain or functional outcomes associated with ESWT. Only high-energy ESWT was consistently associated with significant improvements in both pain and functional outcomes. In 8 studies comparing high- with low-energy ESWT for calcific tendinitis, studies did not demonstrate significant improvements in pain outcomes, although shoulder function was improved with high-energy ESWT. Trials were reported to be generally of low quality with a high risk of bias.
In another 2014 systematic review of RCTs comparing high-energy ESWT with low-energy ESWT, Verstraelen et al. evaluated 5 studies including a total of 359 patients with calcific shoulder tendinitis. (32) Three studies were considered high quality. High-energy ESWT was associated with significant improvements in functional outcomes with a mean difference at 3 months of 9.88 (95% CI: 0.04 to 10.72; p<0.001). High-energy ESWT was more likely to lead to resolution of calcium deposits at 3 months (pooled odds ration [OR], 3.4 [95% CI: 1.35 to 8.58, p=0.009]). Pooled analysis could not be performed for 6-month follow-up data.
An example of an individual RCT is a study by Hsu et al. This trial randomized 33 patients to receive 2 courses of ESWT and 13 patients to sham treatment and measured radiographic outcomes, Constant score and pain scale. (33) ESWT results were good to excellent in 87.9% of shoulders and fair in 12.1%. In the controls, 69.2% had fair and 30.1% had poor results. Calcium deposits were completely eliminated in 7 and partially eliminated in 11 of ESWT patients and partially eliminated in 2 control patients.
In an RCT published since the 2013 and 2011 systematic reviews previously described, Kim et al. compared ultrasound (US)-guided needling combined with subacromial corticosteroid injection with ESWT in patients with unilateral calcific shoulder tendinopathy and US-documented calcifications of the supraspinatus tendon. (34) A total of 62 patients were enrolled and randomized to ESWT versus needling/steroid injection. Fifty-four patients were included in the data analysis after 8 subjects were lost to follow-up. ESWT was performed for 3 sessions separated by 1 week. Radiologic evaluation was blinded, although it is not specified whether evaluators for pain and functional outcomes were blinded. After an average follow-up period of 23.0 months (range, 12.1 to 28.5 months), functional outcomes improved in both groups: for the US-guided needling group, scores on the American Shoulder and Elbow Surgeons (ASES) scale improved from 41.5 to 91.1 (p=0.001) and the Simple Shoulder Test (SST) improved from 38.2% to 91.7% (p=0.03). In the ESWT group, scores on the ASES scale improved from 49.9 to 78.3 (p=0.026) and on the SST from 34.0% to 78.6% (p=0.017). Similarly, VAS pain scores improved from baseline to last follow-up in both groups (6.8-1.1 for US-guided needling [p=0.006], 6.3-2.4 for ESWT [p=0.026]). At the last follow-up visit, calcium deposit size was smaller in the US-needling group compared with the ESWT group (0.5 mm vs 5.6 mm; p=0.001).
An example of a high-energy versus low -energy trial is a study by Schofer et al. This trial compared the effects of high-energy versus low-energy ESWT in 40 patients with rotator cuff tendinopathy in 2009. (35) An increase in function and reduction of pain were found in both groups (p<0.001). Although improvement in Constant score was greater in the high-energy group, there were no statistically significant differences in any outcomes studied (Constant score, pain, subjective improvement) at 12 weeks and 1 year after treatment.
At least one RCT evaluated patients with bicipital tendinitis of the shoulder. (36) This trial enrolled 79 patients with tenosynovitis to ESWT or sham treatment. ESWT was given for 4 sessions once per week. Outcomes were measured at up to 12 months by a VAS for pain and the L’Insalata shoulder questionnaire. The mean decrease in the VAS score at 12 months was greater for the ESWT group compared with sham (4.24 vs. 0.47 units, p<0.001). There were similar changes in the L’Insalata shoulder questionnaire, with an improvement in scores for the ESWT group of 22.8 points.
A number of small RCTs have evaluated the use of ESWT to treat shoulder tendinopathy, which have been summarized in several systematic reviews and meta-analyses. Although some trials have reported a benefit in terms of pain and functional outcomes, particularly for high-energy ESWT for calcific tendinopathy, many available trials have been considered poor quality. Further high-quality trials are needed to determine whether ESWT improves outcomes for shoulder tendinopathy.
ESWT for Achilles Tendinopathy
Al-Abbad and Simon reported on a systematic review of 6 studies on ESWT for Achilles tendinopathy. (37) Included in the review were 4 small RCTs and 2 cohort studies. Satisfactory evidence was found demonstrating ESWT effectiveness in the treatment of Achilles tendinopathy at 3 months in 4 studies. However, 2 of the RCTs reviewed found no significant difference between ESWT and placebo in the treatment of Achilles tendinopathy. (38,39)
In 2014, Mani-Babu et al. reported results of a systematic review and meta-analysis of studies evaluating ESWT for lower limb tendinopathies, including Achilles tendinopathy, patellar tendinopathy, and greater trochanteric pain syndrome. (40) The review included 20 studies overall, 11 of which evaluated ESWT for Achilles tendinopathy, including 5 RCTs, 4 cohort studies, and 2 case-control studies. In pooled analysis, the authors reported that ESWT was associated with greater short-term (<12 months) and long-term (>12 months) improvements in pain and function compared with nonoperative treatments, including rest, footwear modifications, anti-inflammatory medication, and gastrocnemius-soleus stretching and strengthening. The authors note that findings from RCTs of ESWT for Achilles tendinopathy are contradictory, but that there is at least some evidence for short-term improvements in function with ESWT.
Costa et al reported a randomized double-blind, placebo-controlled trial of ESWT for chronic Achilles tendon pain treated monthly for 3 months in 2005.(38) The study randomized 49 participants and was powered to detect a 50% reduction in VAS pain scores. No difference in pain relief at rest or during sport participation was found at 1 year. Two older ESWT-treated participants experienced tendon ruptures.
In 2008, Rasmussen et al. reported a single-center double-blind controlled trial with 48 patients, half of them randomized after 4 weeks of conservative treatment to 4 sessions of active rESWT and half to sham ESWT. (39) The Primary end point was AOFAS score measuring function, pain, and alignment and pain on VAS. The AOFAS score after treatment increased from 70 to 88 in the ESWT group and from 74 to 81 in the control (p=0.05). Pain was reduced in both groups with no statistically significant difference between groups. The authors noted that the AOFAS score may not be appropriate for the evaluation of treatment of Achilles tendinopathy.
ESWT for Patellar Tendinopathy
Van Leeuwen et al. conducted A literature review to study the effectiveness of ESWT for patellar tendinopathy and to draft a treatment protocol which included a review of 7 articles. (41) The authors found that most studies had methodologic deficiencies, small numbers and/or short follow-up periods, and treatment parameters varied among studies. They concluded that ESWT appears to be safe and promising treatment but that a treatment protocol cannot be recommended and further basic and clinical research is required. In an RCT of patients with chronic patellar tendinopathy (N=46), despite at least 12 weeks of nonsurgical management, improvements in pain and functional outcomes were significantly greater (p<0.05) with plasma-rich protein injections than ESWT at 6 and 12 months, respectively. (42)
In the 2014 systematic review and meta-analysis of ESWT for lower extremity tendinopathies by Mani-Babu et al., previously described, the authors identified 7 studies of ESWT for patellar tendinopathy, including 2 RCTs, 1 quasi-RCT, 1 retrospective cross-sectional study, 2 prospective cohort studies, and 1 case-control study. (40) The 2 RCTs came to different conclusions: 1 RCT found no difference in outcomes between ESWT and placebo at 1, 12, or 22 weeks, whereas an earlier RCT found improved outcomes on vertical jump test and Victorian Institute of Sport Assessment Questionnaire–Patellar scores at 12 weeks with ESWT compared with placebo. Two studies which evaluated outcomes beyond 24 months found that ESWT was comparable with patellar tenotomy surgery and better than nonoperative treatments.
ESWT for Medial Tibial Stress Syndrome
In 2009, Rompe et al published a report on the use of ESWT in medial tibial stress syndrome (MTSS), commonly known as “shin splints.” (43) In this non-randomized cohort study, 47 patients with MTSS for at least 6 months received 3 weekly sessions of rESWT and were compared with 47 age-matched controls at 4 months. Mild adverse events were noted in 10 patients: skin reddening in 2 patients and pain during the procedure in 8 patients. Patients rated their condition on a 6-point Likert scale. Successful treatment was defined as self-rating “completely recovered” or “much improved.” The authors reported a significant success rate of 64% (30/47) in the treatment group compared with 30% (14/47) in the control group. This study represents another potential use for ESWT. In a letter to the editor, Barnes raised several limitations of this nonrandomized study, including the possibility of selection bias. (44) Larger randomized trials are needed.
ESWT for Spasticity
Lee et al. conducted a systematic review and meta-analysis of studies evaluating ESWT for patients with spasticity secondary to a brain injury. (45) Studies were included that evaluated ESWT as sole therapy and that reported pre- and postintervention modified Ashworth Scale scores. Five studies were included, 4 examining spasticity in the ankle plantarflexor and 1 examining spasticity in the wrist and finger flexors; 3 studies evaluated poststroke spasticity and two evaluated spasticity associated with cerebral palsy. Immediately post-ESWT, modified Ashworth Scale scores improved significantly compared with baseline (standardized mean difference [SMD], -0.792; 95% CI: -1.001 to -0.583; p<0.001). After 4 weeks post-ESWT, modified Ashworth Scale scores continued to demonstrate significant improvements compared with baseline (SMD, -0.735; 95% CI: -0.951 to -0.519; p<0.001). A strength of this meta-analysis is that it used a consistent and well-definable outcome measure. However, the modified Ashworth Scale does not account for certain clinically-important factors related to spasticity, including pain and functional impairment.
Randomized Controlled Trials
The Efficacy and safety of radial ESWT in the treatment of spasticity in patients with cerebral palsy was examined in a small RCT from Europe in 2011. (46) The 15 patients in this study were divided into 3 groups (ESWT in a spastic muscle, ESWT in both spastic and antagonistic muscle, placebo ESWT) and treated in 3 weekly sessions. Spasticity was evaluated in the lower limbs by passive range of motion with a goniometer and in the upper limbs with the Ashworth scale (0 [not spasticity] to 4 [severe spasticity]) at 1, 2, and 3 months after treatment. Blinded evaluation showed significant differences between the ESWT and placebo groups for range of motion and Ashworth scale. For the group in which the spastic muscle only was treated, there was an improvement of 1 point on the Ashworth scale (p=0.05 in comparison with placebo); for the group in which both the spastic and antagonistic muscle was treated, there was an improvement of 0.5 points (not statistically significant in comparison with placebo); and for the placebo group, there was no change The significant improvements were maintained at 2 months after treatment, but not at 3 months.
Daliri et al. evaluated the efficacy of a single session of ESWT for treatment of poststroke wrist flexor spasticity in a single-blinded trial in which each patient received both sham control and active stimulation. (47) Fifteen patients with poststroke spasticity at a mean 30 months poststroke were included, each of whom received 1 sham stimulation followed 1 week later by 1 active ESWT treatment. Investigators were not blinded. Outcomes evaluated included the modified Ashworth Scale to evaluate spasticity intensity, the Brunnstrom recovery stage tool to assess motor recovery, and the neurophysiological measure of Hmax/Mmax to measure alpha motoneuron excitability. Ashworth scores and Brunnstrom recovery stage scores did not improve after sham treatment. Ashworth Scale scores improved significantly from baseline (mean, 3) to after active ESWT treatment (mean score, 2, 2, and 2 immediately posttherapy, 1 week posttherapy, and 5 weeks posttherapy, respectively; p<0.05). H¬max/Mmax¬ ratio improved from 2.30 before therapy to 1 week after active ESWT (p=0.047). Brunnstrom recovery stage scores did not significantly improve after active ESWT. Given the lack of a comparison with a control group, this study provides limited evidence about the efficacy of ESWT for poststroke spasticity.
Santamato et al. evaluated outcomes after a single session of ESWT for poststroke plantarflexor spasticity (equinus foot) in 23 subjects. (48) Subjects with gastrocnemius/soleus Heckmann scores on US from I-III (of a maximum score of IV, corresponding to very high muscle echo intensity due to fat and fibrosis) had significant improvements in modified Ashworth Scale scores from baseline to immediately post-ESWT (3.5-2.1, p<0.01) and from baseline to 30 days post-ESWT (3.5-2.6, p<0.05). Those with a Heckmann score of IV showed improvements in modified Ashworth Scale scores from baseline to immediately post-ESWT (4.7-3.3, p<0.05), but did not have 30-day scores that differed significantly from baseline. Results were similar for passive ankle dorsiflexion scores.
A relatively small body of evidence, with limited RCT evidence, is available to evaluate the use of ESWT for spasticity. Several studies have demonstrated improvements in spasticity measures after ESWT. Further controlled trials are needed to determine whether ESWT leads to clinically meaningful improvements in pain and/or functional outcomes for spasticity.
ESWT for Osteonecrosis of the Femoral Head
A systematic review of ESWT in osteonecrosis (avascular necrosis) of the femoral head was conducted by Alves et al in 2009. (49) Only 5 articles, all from non-U.S. sites, were identified: 2 RCTs, one comparative study, one open-label study, and one case report for a total of 133 patients. Several studies were from one center in Taiwan. Of the 2 RCTs, one (n=48) was randomized to the use of concomitant alendronate; ESWT treatments were in both arms of the study and ESWT was therefore not the comparator. The other RCT compared ESWT with a standard surgical procedure. All results noted a reduction in pain over the time of the study, which was attributed by each of the study’s authors to a positive effect of ESWT. However, the authors of this review noted the limitations of the available evidence: lack of double-blind design, small numbers of patients included, short duration of follow-up, and non-standard intervention, e.g., energy level and number of treatments.
A comparative study not included in the Alves et al. systematic review was published by Chen et al in 2009. (50) In this small study, for each of 17 patients with bilateral hip osteonecrosis, one side was treated with total hip arthroplasty, while the other was treated with ESWT. Each patient was evaluated at baseline and after treatment using VAS for pain and Harris hip score, a composite measure of pain and hip function. There was a significant reduction in scores before and after treatment in both treatment groups. Hips treated with ESWT were also evaluated for radiographic reduction of bone marrow edema on magnetic resonance imaging, which also appeared to be reduced. The authors then compared the ESWT-treated data with the total hip arthroplasty results, stating that the magnitude of improvement was greater for the ESWT-treated hips. However, hips were not randomized to treatment intervention; the side with the greater degree of disease was treated with surgery in each case. Moreover, time between hip interventions within the same patient averaged 17.3 months, with a range of 6 to 36 months; in all but one case, surgery preceded ESWT. Therefore, conclusions about the superiority of one intervention over the other cannot be made.
A limited body of evidence addresses ESWT for osteonecrosis of the femoral head, including 2 small RCTs. The available evidence is insufficient to allow conclusions about the efficacy of ESWT for osteonecrosis.
ESWT for Nonunion or Delayed Union of Acute Fractures
In 2010, Zelle et al reviewed the English and German medical literature for studies of ESWT in the treatment of fractures and delayed union/nonunion, restricted to studies with greater than 10 patients. (51) Ten case series and one RCT were identified. The number of treatment sessions, energy protocols, and definitions of nonunion varied across studies; union rate after intervention was likewise heterogeneous, ranging from 40.7% to 87.5%. The authors concluded the overall quality of evidence is conflicting and of poor quality.
The RCT included in the Zelle review reported on the use of ESWT in acute long bone fractures. (52) Wang et al randomized trauma patients (n=56) with femur or tibia fractures to a single ESWT treatment following surgical fixation while still under anesthesia. Patients in the control group underwent surgical fixation but did not receive the ESWT treatment. Patients were evaluated for pain and percent weight-bearing capability on the affected leg by an independent, blinded evaluator. Radiographs taken at these same intervals were evaluated by a radiologist blinded to study group for fracture healing or nonunion. Both groups showed significant improvement in pain scores and weight-bearing status. Between-group comparisons of pain by VAS and weight bearing favored study patients at each interval. At six months, patients who had received ESWT had VAS scores of 1.19 compared with 2.47 in the control group (p<0.001); mean percentage of weight bearing at 6 months was 87% versus 78%, respectively (p=0.01). Radiographic evidence of union at each interval also favored the study group. At 6 months, 63% (17/27) of the study group achieved fracture union compared with 20% (6/30) in the control group (p<0.001). The authors note some limitations to the study: the small number of patients in the study, surgeries performed by multiple surgeons, and questions regarding adequacy of randomization.
One RCT of ESWT compared with surgery for nonunion of long bone fractures was identified. Cacchio et al. enrolled 126 patients into 3 groups: low- or high-energy ESWT therapy, or surgery.(53) Patients were identified for participation in the study if referred to one of 3 Italian centers with nonunion fractures, here defined as at least 6 months without evidence of radiographic healing. The primary end point was radiographic evidence of healing. Secondary end point data of pain and functional status were collected by blinded evaluators. Neither patients nor treating physicians were blinded. At 6 months, rates in the lower energy ESWT, higher energy ESWT, and surgical arms had similar healing rates (70%, 71%, and 73%, respectively). There was no significant difference among the groups at this stage. All groups’ healing rates improved at further follow-up at 12 and 24 months without significant between-group differences. Secondary end points of pain and disability were also examined and were similar. Lack of blinding may have led to differing levels of participation in other aspects of the treatment protocol.
The evidence related to the use of ESWT for the treatment of fractures or for fracture nonunion or delayed union includes several relatively small RCTs with methodologic issues noted, along with case series. The available evidence is insufficient to allow conclusions about the efficacy of ESWT in fracture nonunion, delayed union, and acute long bone fractures.
ESWT for Other Conditions
ESWT has been investigated in small studies for other conditions, including coccydynia in a case series of 2 patients (54) and painful neuromas at amputation sites in a small RCT including 30 subjects. (55)
In the 2014 systematic review and meta-analysis of ESWT for lower extremity tendinopathies by Mani-Babu et al., previously described, the authors reviewed 2 studies of ESWT for greater trochanteric pain syndrome, including 1 quasi-RCT comparing ESWT with home therapy or corticosteroid injection and 1 case-control study comparing ESWT with placebo. (40) ESWT was associated with some benefits compared with placebo or home therapy.
Ongoing and Unpublished Clinical Trials
A search of ClinicalTrials.gov on January 12, 2015, identified several randomized trials evaluating ESWT for musculoskeletal conditions that are currently enrolling patients:
Summary of Evidence
Extracorporeal shock wave therapy (ESWT) has been investigated for use in a variety of musculoskeletal conditions. For plantar fasciitis, numerous RCTs, including several well-designed-double blinded RCTs, have demonstrated mixed findings, with some studies reporting a benefit and others reporting no benefit. In cases where statistically significant differences are reported, the magnitude of effect for some of the outcomes is of uncertain clinical significance. Given the lack of demonstrated benefit in randomized controlled trials (RCTs), ESWT is considered investigational for plantar fasciitis.
A number of studies, including relatively small RCTs that have some methodologic flaws, have evaluated ESWT for tendinopathies, including lateral epicondylitis, shoulder tendinopathy, Achilles tendinopathy, and patellar tendinopathy. In general, although some RCTs demonstrate benefits in pain and functional outcomes associated with ESWT, the limited number of high-quality RCT evidence precludes conclusions about the efficacy of ESWT for tendinopathies. Similarly, high-quality RCT evidence for the use of ESWT for medial tibial stress syndrome, osteonecrosis of the femoral head, and acute fractures and delayed fracture union is limited. As a treatment for spasticity, several small studies have demonstrated short-term improvements in modified Ashworth Scale scores, but direct evidence regarding the effect of ESWT on more directly clinically meaningful measures such as pain or function are lacking. Differences in treatment parameters among studies, including energy dosage, method of generating and directing shock waves, and use or absence of anesthesia, limit generalizations from results of multiple studies. Given the limitations in the evidence base, ESWT is considered investigational for the treatment of musculoskeletal conditions other than plantar fasciitis, including tendinopathies, (lateral epicondylitis, patellar tendinopathy, Achilles tendinopathy, shoulder tendinopathy), spasticity, medial tibial stress syndrome, osteonecrosis of the femoral head, and for prevention or treatment of fracture nonunion or delayed union.
Practice Guidelines and Position Statements
In 2010, Thomas et al published a revised practice guideline on the treatment of heel pain on behalf of the American College of Foot and Ankle Surgeons.(56) This guideline identifies ESWT as a third tier treatment modality in patients who have failed other interventions, including steroid injection. The guideline recommends ESWT as a reasonable alternative to surgery.
The National Institute for Clinical Excellence has published guidance on ESWT for a number of applications.
A 2007 summary by the Canadian Agency for Drugs and Technologies in Health (CADTH) noted that results from randomized trials of ESWT for plantar fasciitis have been conflicting. (62) The report notes that the “lack of convergent findings from randomized trials of ESWT for chronic plantar fasciitis suggests uncertainty about its effectiveness. The evidence reviewed in this bulletin does not support the use of this technology for this condition.” Similarly, a 2007 report by CADTH on ESWT for chronic lateral epicondylitis notes that the results from randomized trials have been conflicting and half of the studies showed no benefit over placebo for any outcome measures. (63) The report notes that “the lack of convincing evidence regarding its effectiveness does not support the use of ESWT for CLE (chronic lateral epicondylitis).” A third 2007 summary by the CADTH concludes that ”the current evidence supports the use of high-energy ESWT for chronic calcific rotator cuff tendonitis that is recalcitrant to conventional conservative treatment, although more high-quality RCTs with larger sample sizes are required to provide more convincing evidence.” (64)
U.S. Preventive Services Task Force Recommendations
Medicare National Coverage
There is no national coverage determination (NCD). In the absence of an NCD, coverage decisions are left to the discretion of local Medicare carriers.
Extracorporeal shock wave involving musculoskeletal system, not otherwise specified; low energy
high energy, performed by a physician, requiring anesthesia other than local, involving lateral humeral epicondyle
Extracorporeal shock wave, high-energy, performed by a physician, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia
Type of Service
Place of Service
Add to Medicine Section - New Policy
Replace policy - Patient criteria updated to include patient criteria, Policy statement changed to “may be considered medically necessary.” Name changed to include “and Other Musculoskeletal Conditions”. Policy replaces CP.MP.BC.2.01.40.
Replace policy - Policy updated with TEC assessments. Policy replaces CP.MP.BC.2.01.109.
Replace Policy - Policy replaces CP.MP.BC.2.01.40. No change to policy statement.
Replace Policy - Policy replaces CP.MP.PR.2.01.109. Policy updated with additional references for treatment of plantar fasciitis; policy statement is changed to investigational. Effective July 15, 2004 due to notification process.
Replace Policy - Policy updated with October 2004 TEC Assessments; endonitis of the elbow added to investigational status in the policy statement.
Replace Policy - Policy updated with CPT codes effective 7/1/05.
Codes updated - No other changes.
Replace Policy - Policy updated with additional references and information on newly approved ESWT devices; no change to policy statement.
Update Scope and Disclaimer - No other changes.
Cross Reference Update - No other changes.
Replace Policy - Policy updated with literature search through April 2007; no change in policy statement. References added.
Replace Policy - Policy updated with literature search. Policy statement updated to include radial ESWT to the investigational criteria. References added.
Cross Reference Update - No other changes.
Replace policy - Policy updated with literature search; no change to the policy statement. References added.
Replace Policy - Policy updated with literature search; reference numbers 37-44 added; references 13,14,16,17 and 45-48 updated. No change in policy statement. ICD-10 codes added.
Replace policy. Policy updated with literature search through December 2011; references 25 and 36 added and references reordered; some references removed. No change in policy statement.
Update Coding Section – ICD-10 codes are now effective 10/01/2014.
Replace policy. Policy updated with literature review, references 11, 19, 20, 21, 24 added. No change to policy statements.
Annual review. Policy updated with literature review through January 20, 2014. Moved details of high/low intensity therapy from the Regulatory section to the Description section. References 5-7, 24-25, 30, 34 added; others renumbered/removed. Policy statements unchanged. ICD-9 and ICD-10 diagnosis and procedure codes removed; they are not utilized in policy adjudication.
Annual Review. Policy updated with literature review through January 12, 2015. References 8, 15, 17, 28, 31, 34, 40, 45, 47-48, and 54-55 added. Editorial changes made for clarity to policy statements; intent of policy statements unchanged.
Disclaimer: This medical policy is a guide in evaluating the medical necessity of a particular service or treatment. The Company adopts policies after careful review of published peer-reviewed scientific literature, national guidelines and local standards of practice. Since medical technology is constantly changing, the Company reserves the right to review and update policies as appropriate. Member contracts differ in their benefits. Always consult the member benefit booklet or contact a member service representative to determine coverage for a specific medical service or supply. CPT codes, descriptions and materials are copyrighted by the American Medical Association (AMA).