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Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions

Policy Number: MP-076

Latest Review Date: July 2019

Category: Medical                                                                 

Policy Grade:  A

Description of Procedure or Service:

Extracorporeal shock wave therapy (ESWT) is a noninvasive method used to treat pain with shock or sound waves directed from outside the body onto the area to be treated, (e.g., the heel in the case of plantar fasciitis). Shock waves are generated at high- or low-energy intensity, and treatment protocols can include more than one treatment. ESWT has been investigated for use in a variety of musculoskeletal conditions.

Chronic Musculoskeletal Conditions

Chronic musculoskeletal conditions (e.g., 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 calcific deposits by shock waves may loosen adjacent structures and promote resorption of calcium, thereby decreasing pain and improving function.

Plantar Fasciitis

Plantar fasciitis is a 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 persists, 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 is unproven that heel spurs cause the pain. Asymptomatic heel spurs can be found in up to 10% of the population.

Tendinitis and Tendinopathies

Common tendinitis and tendinopathy syndromes are summarized in Table 1. Many tendinitis and tendinopathy syndromes are related to overuse injury.

Table 1: Tendinitis and Tendinopathy Syndromes

Disorder

Location

Symptoms

Conservative Therapy

Other Therapies

Lateral epicondylitis (“tennis elbow”)

Lateral elbow (insertion of wrist extensors)

Tenderness over lateral epicondyle and proximal wrist extensor muscle mass; pain with resisted wrist extension with elbow in full extension; pain with passive terminal wrist flexion with elbow in full extension

  • Rest
  • Activity modification
  • NSAIDs
  • Physical therapy
  • Orthotic devices

Corticosteroid injections; joint débridement (open or laparoscopic)

Shoulder tendinopathy

Rotator cuff muscle tendons, most commonly supraspinatus

Pain with overhead activity

  • Rest
  • Ice
  • NSAIDs
  • Physical therapy

Corticosteroid injections

Achilles tendinopathy

Achilles tendon

Pain or stiffness 2-6 cm above the posterior calcaneus

  • Avoidance of aggravating activities
  • Ice when symptomatic
  • NSAIDs
  • Heel lift

Surgical repair for tendon rupture

Patellar tendinopathy (“jumper’s knee”)

Proximal tendon at lower pole of patella

Pain over anterior knee and patellar tendon; may progress to tendon calcification and/or tear

  • Ice
  • Supportive taping
  • Patellar tendon straps
  • NSAIDs

NSAIDs: nonsteroidal anti-inflammatory drugs

Fracture Nonunion and Delayed Union

The definition of a fracture nonunion remains controversial, particularly the duration necessary to define nonunion. One proposed definition is a failure of progression of fracture healing for at least 3 consecutive months (and at least 6 months after the fracture) accompanied by clinical symptoms of delayed/nonunion (pain, difficulty weight bearing). The following criteria to define nonunion were used to inform this review:

  • at least 3 months since the date of fracture;
  • serial radiographs have confirmed that no progressive signs of healing have occurred;
  • the fracture gap is 1cm or less; and
  • the patient can be adequately immobilized and is of an age likely to comply with non-weight bearing limitation.

The 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. (In contrast, nonunion serial radiographs show no evidence of healing.)

Other Musculoskeletal and Neurologic Conditions

Other musculoskeletal conditions include medial tibial stress syndrome, osteonecrosis (avascular necrosis) of the femoral head, coccydynia, and painful stump neuromas. Neurologic conditions include spasticity, which refers to a motor disorder characterized by increased velocity-dependent stretch reflexes. It is a characteristic of upper motor neuron dysfunction, which may be due to a variety of pathologies.

Chronic Pelvic Pain

Prostatitis is one of the most frequent urological diagnoses, resulting in more than two million physician visits in the United States annually. Most men have the abacterial form of chronic prostatitis, or chronic pelvic pain syndrome (CPPS). Symptoms of CPPS are urinary and erectile dysfunction, pain focused in the prostate region, as well as perineal, inguinal, scrotal and suprapubic pain.

CPPS is thought to be manifested as a myofascial pain syndrome with an abnormal tone of the periprostatic musculature with neurological components.

Analgesics, anti-inflammatory agents, antibiotics, α-receptor blockers and 5α-reductase inhibitors are used alone and in various combinations without sufficient clarification of the evidence and effectiveness of each of these treatments. Therefore, clinicians have increasingly begun to look for non-drug treatment options. Physiotherapy, “trigger-point” massage and electromagnetic treatment have been tried.

Treatment

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.

For tendinitis and tendinopathy syndromes, conservative treatment often involves rest, activity modifications, physical therapy, and anti-inflammatory medications (see Table 1).

Extracorporeal Shock Wave Therapy

Also known as orthotripsy, extracorporeal shock wave therapy (ESWT) 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.

Other mechanisms are also thought to be involved in 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 healing. Finally, shock waves have been shown to stimulate osteogenesis and promote callous formation in animals, which is the basis for trials of ESWT in delayed union or nonunion of bone fractures.

There are 2 types of ESWT: focused and radial. Focused ESWT sends medium- to high-energy shockwaves of single pressure pulses lasting microseconds, directed on a specific target using ultrasound or radiographic guidance. Radial ESWT (RSW) transmits low- to medium-energy shockwaves radially over a larger surface area. The Food and Drug Administration (FDA) approval was first granted in 2002 for focused ESWT devices and in 2007 for RSW devices.

Policy:

Extracorporeal shock wave therapy (ESWT), using either a high- or low-dose protocol or radial ESWT is considered not medically necessary and investigational when used to treat 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.

Extracorporeal shock wave therapy is considered not medically necessary and investigational when used to treat chronic pelvic pain syndrome (CPPS) resulting from abacterial chronic prostatitis and is considered investigational

Key Points:

The most recent literature update covered the period through April 3, 2019. Following is a summary of key studies to date.

This review was informed by a TEC Assessment (2001) that concluded extracorporeal shock wave therapy (ESWT) met TEC criteria as a treatment for plantar fasciitis in patients who had not responded to conservative therapies. Another TEC Assessment (2003) reviewed the subsequent literature on ESWT for musculoskeletal conditions with a focus on 3 conditions: plantar fasciitis, tendinitis of the shoulder, and tendinitis of the elbow. 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. In 2004, updated TEC Assessments were completed for plantar fasciitis and tendinitis of the elbow. These Assessments concluded that ESWT did not meet TEC criteria for the treatment of these conditions.

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 posttreatment measures of functional status are also used, such as 12-Item Short-Form Health Survey and 36-Item Short-Form Health Survey. Minor adverse events of ESWT are common but transient, including local pain, discomfort, trauma, bleeding, and swelling. More serious adverse events of ESWT may potentially include neurologic damage causing numbness or tingling, permanent vascular damage, or rupture of a tendon or other soft tissue structure.

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are length of life, quality of life, and ability to function, including benefits and harms. Every clinical condition has specific outcomes that are important to patients and to managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance and the quality and credibility. To be relevant, studies must represent one or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. RCTs are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Plantar Fasciitis

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative therapy (eg, stretching, heel supports), nonsteroidal anti-inflammatory therapy, and local corticosteroid injection, in patients with plantar fasciitis.

The question addressed in this evidence review is: Does the use of extracorporeal shock wave therapy for plantar fasciitis improve the net health outcome?

The following PICO were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with plantar fasciitis.

Interventions

The therapy being considered is  extracorporeal shock wave therapy.

ESWT is a noninvasive method used to treat pain with shock or sound waves directed from outside the body onto the area to be treated (e.g., the heel). Shock waves are generated at high- or low-energy intensity, may be radial or focused, and treatment protocols can include more than one treatment. ESWT has been investigated for use in a variety of musculoskeletal conditions.

Comparators

Comparators of interest include conservative therapy (eg, stretching, heel supports), nonsteroidal antiinflammatory therapy, and local corticosteroid injection. Comparators are managed by podiatrists, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are pain symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Table 2. Outcomes of Interest for Individuals with Plantar Fasciitis

Outcomes

Details

Timing

Pain reduction

  • VAS assessment, with successful pain reduction of 50–60% or ≥4 cm reduction in score
  • Roles and Maudsley pain scores of "good" or "excellent"
  • Pain comparison both to baseline and to control group measurements
  • Patient-assessed and investigator-assessed pain level

Generally measured for up to

12 weeks

Functional improvement

  • Roles and Maudsley function score of "good" or "excellent"
  • Patient ability to work and perform activities of daily living

Generally measured for up to

12 weeks

Quality of life

Patient-reported satisfaction with treatment

Generally measured for up to

12 weeks

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

Eight studies met the inclusion criteria for the TEC Assessment (2004).  Five double-blind RCTs, reporting on 992 patients, were considered high quality. Overall, evidence included in this Assessment showed a statistically significant effect on the 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. Complete information on the number needed to treat to achieve 50% to 60% reduction in morning pain came from 2 studies of high-energy ESWT (and including confidential data provided by Dornier). The combined number needed to treat was 7 (95% confidence interval [CI], 4 to 15). Improvements in pain measures were not associated with improvements in function. The effect size for improvement in pain with activity was not significant, 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 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 a significant difference in the quality of life measurement (12-Item Short-Form Health Survey Physical and Mental Component Summary scores) or use in pain medication.

Three recent meta-analyses have been published, with a total of 21 studies. All three meta-analyses used the Cochrane risk of bias tool to assess the quality of included RCTs. Results must be interpreted with caution due to the following limitations: lack of uniform measurement of outcomes, heterogeneity in ESWT protocols (focused and radial, low- and high- intensity/energy, the number of shocks per treatment, treatment duration, and differing comparators), and lack of functional outcomes.

In their systematic review and meta-analysis, Li et al (2018) assessed RCTs to determine whether ESWT or corticosteroid injections (CSIs) are more effective in plantar fasciitis pain reduction (measured using VAS), treatment success, recurrence rate, function scores, and adverse events. The review included 9 RCTs with a total of 658 cases in which 330 participants received ESWT and 328 received CSI. Meta-analyses showed that CSI is more effective than low-intensity ESWT at VAS reduction (3 months post-treatment: MD, -1.67; 95% CI -3.31 to -0.04; P=0.04; I2=85%). However, high-intensity ESWT is more effective than CSI (2–3 months posttreatment: MD, 1.12; 95% CI, 0.52–1.72; P=0.0003; I2=59%). One study followed patients for 12 months posttreatment and found no significant different in pain outcomes, and no significant difference was found in recurrence rates or functional scores between ESWT and CSI. Four ESWT recipients in one trial reported severe headache or migraine following the procedure; no severe adverse effects were reported for CSI. Though CSI is more readily available than ESWT, the authors reported that ESWT recipients have a faster return to full activities after the procedure. One limitation of this systematic review is the inclusion of only 9 trials with 658 cases, only 2 of which followed up for as long as 1 year. Also, the doses of CSI varied across studies, which may affect heterogeneity. This study is not included in the results summary table (Table 5) because its comparator is CSI rather than placebo.

The meta-analysis by Sun et al (2017) evaluated the efficacy of all ESWT, then conducted subgroup analyses on the type of ESWT (focused shock wave [FSW], radial shock wave [RSW]). The literature search, conducted through July 2016, identified 9 trials for inclusion (total N=935 patients). An outcome in all 9 trials was “therapeutic success” rate, defined as a proportion of patients experiencing a decrease in VAS pain score from baseline more than a threshold of either at least 50% or at least 60%. Only 4 studies provided data on reducting pain (3 FSW, 1 RSW). Pooled results are summarized in Table 2.

A meta-analysis by Lou et al (2017) evaluated the efficacy of ESWT without local anesthesia in patients with recalcitrant plantar fasciitis. The literature search, conducted through September 2015, identified 9 trials for inclusion (total N=1174 patients). Meta-analyses focused on pain reduction at 12 weeks of follow-up: overall, at first step in the morning, and during daily activities. Three RCTs also provided data to analyze improvement in the Roles and Maudsley score to excellent or good at 12-week follow-up.

A systematic review and meta-analysis by Yin et al (2014) evaluated 7 RCTs or quasi-RCTs of ESWT for chronic (≥6 months) recalcitrant plantar fasciitis. Treatment success rate of the 5 trials (n=448 patients) that evaluated low-intensity ESWT showed it was more likely than the control treatment to be successful (pooled relative risk, 1.69; 95% CI, 1.37 to 2.07; p<0.001). In a pooled analysis of 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 was restricting the population to patients with at least 6 months of symptoms because this clinical population is more difficult to treat and less likely to respond to interventions. However, a weakness was the heterogeneity in the definition of “treatment success” across trials, which makes interpreting the pooled analysis challenging.

Meta-analyses of RCTs published in 2013 have reported that ESWT for plantar fasciitis is better than or comparable to placebo in reducing pain and improving functional status in the short-term. However, RCTs were subject to a number of limitations. They reported inconsistent results, and heterogeneity across them sometimes precluded meta-analysis of pooled data. Outcomes measured and trial protocols (e.g., dose intensities, type of shockwaves, the frequency of treatments) also lacked uniformity. Also, given that plantar fasciitis often resolves within a 6-month period, longer follow-up would be required to compare ESWT results with the natural resolution of the condition. The clinical significance of results reported at shorter follow-up (e.g., 3 months) is uncertain.

Randomized Controlled Trials

Trials with Sham Controls

Several representative RCT trials are discussed next. For example, Gollwitzer et al (2015) reported on results of a sham-controlled randomized trial, with patients and outcome assessments blinded, evaluating ESWT for plantar fasciitis present for at least 6 months and refractory to at least 2 nonpharmacologic and 2 pharmacologic treatments. A total of 250 subjects were enrolled (126 in the ESWT group, 124 in the placebo group). The trial’s primary outcome was an overall reduction of heel pain, measured by percentage change of the VAS composite score at 12 weeks. Median decrease for the ESWT group was -69.2% and -34.5% for the placebo group (effect size, 0.603; p=0.003). Secondary outcomes included success rates defined as decreases in heel pain of at least 60% from baseline. Secondary outcomes generally favored the ESWT group. Most patients reported satisfaction with the procedure. Strengths of this trial included intention-to-treat analysis, use of validated outcome measures, and at least some reporting of changes in success rates (rather than percentage decrease in pain) for groups. There was some potential for bias because treating physicians were unblinded.

In 2005, results were reported from the U.S. Food and Drug Administration‒regulated trials delivering ESWT with the Orthospec and Orbasone Pain Relief System. In the RCT evaluating Orthospec, investigators conducted a multicenter, double-blind, sham-controlled trial randomizing 172 participants with chronic proximal plantar fasciitis failing conservative therapy to ESWT or to sham treatments. At 3 months, the ESWT arm had lower investigator-assessed pain levels with the application of a pressure sensor (0.94 points lower on a 10-point VAS; 95% CI, 0.02 to 1.87). However, this improvement was not found for patient-assessed activity and function. In the trial supporting the Food and Drug Administration approval of Orbasone, investigators conducted a multicenter, randomized, sham-controlled, double-blind trial evaluating 179 participants with chronic proximal plantar fasciitis. At 3 months, both active and sham groups improved in patient-assessed pain levels on awakening (by 4.6 and 2.3 points, respectively, on a 10-point VAS; absolute difference between groups, 2.3; 95% CI, 1.5 to 3.3). While ESWT was associated with more rapid and statistically significant improvement in a mixed-effects regression model, insufficient details were provided to evaluate the analyses.

Gerdesmeyer et al (2008) reported on a multicenter, double-blind RCT of RSW conducted for Food and Drug Administration premarket approval of the Dolorclast. The trial randomized 252 patients, 129 to RSW and 122 to sham treatment. Patients had heel pain for at least 6 months and had failed at least 2 non-pharmacologic and 2 pharmacologic treatments. Over 90% of patients were compliant with the 3 weekly treatment schedule. Outcome measures were composite heel pain (pain on first steps of the day, with activity and as measured with Dolormeter), change in VAS pain score, and Roles and Maudsley score measured at 12 weeks and 12 months. Success was defined as a reduction of 60% or more in 2 of 3 VAS scores, or patient ability to work and complete activities of daily living, treatment satisfaction, and requiring no further treatment. Secondary outcomes at 12 weeks included changes in Roles and Maudsley score, 36-Item Short-From Health Survey Physical Component Summary score, 36-Item Short-Form Health Survey Mental Component Summary score, investigator’s and patient’s judgment of effectiveness, and patient recommendation of therapy to a friend. At 12-week follow-up, RSW resulted in a decrease of the composite VAS score by 72.1% vs 44.7% after placebo (p=0.022). Success rates for the composite heel pain score were 61% and 42% (p=0.002). Statistically significant differences were noted in all secondary measures. A number of limitations prevent definite conclusions from being reached: the limited data on specific outcomes (e.g., presenting percent changes rather than actual results of measures); inadequate description of prior treatments; use of a composite outcome measure; no data on the use of rescue medication; and uncertainty in the clinical significance of changes in outcome measures.

Trials with Active Comparators

Radwan et al (2012) compared ESWT with endoscopic plantar fasciotomy in 65 patients who had refractory plantar fasciitis and had failed at least 3 lines of treatment in the preceding 6 months. Outcome measures included a 0-to-100 VAS assessing morning pain, the American Orthopaedic Foot and Ankle (AOFAS) Ankle-Hindfoot Scale score, and patient subjective assessment using the 4-item Roles and Maudsley score. Improvements were similar in both treatment groups at the 1-year follow-up; however, a larger proportion of patients in the surgery group continued to report success at years 2 and 3 compared with those of the ESWT group.

RCTs comparing ESWT and RSW with corticosteroid injection and conservative treatment (exercise, orthotic support) have been performed, with mixed findings. As the follow-up period for these studies are 3 months or less, the clinical significance of these results are uncertain.

Nonrandomized Studies

Nonrandomized studies have reported outcomes after ESWT for plantar fasciitis, but given the availability of randomized trials, such studies do not provide additional evidence on ESWT’s efficacy compared with alternatives.

Section Summary: Plantar Fasciitis

Numerous RCTs were identified, including several well-designed double-blinded RCTs, that evaluated ESWT for the treatment of plantar fasciitis. Seven systematic reviews and meta-analyses have been conducted, covering a total of 27 studies. Pooled results were inconsistent. Some meta-analyses reported that ESWT reduced pain, while others reported nonsignificant pain reduction. Reasons for the differing results included lack of uniformity in the definitions of outcomes and heterogeneity in ESWT protocols (focused vs radial, low- vs high-intensity/energy, number and duration of shocks per treatment, number of treatments, and differing comparators). Some studies reported significant benefits in pain and functional improvement at three months, but it is not evident that the longer-term disease natural history is altered with ESWT. Currently, it is not possible to concluded definitively that ESWT improves outcomes for patients with plantar fasciitis.

Lateral Epicondylitis

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative therapy (e.g., physical therapy) and nonsteroidal anti-inflammatory therapy, in patients with lateral epicondylitis.

The question addressed in this evidence review is: does the use of extracorporeal shock wave therapy for lateral epicondylitis improve the net health outcome?

The following PICO were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with lateral epicondylitis.

Interventions

The therapy being considered is ESWT.

Comparators

Comparators of interest include conservative therapy (e.g., physical therapy) and nonsteroidal anti-inflammatory therapy. Comparators are actively managed by orthopedic surgeons, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Table 3. Outcomes of Interest for Individuals with Lateral Epicondylitis

Outcomes

Details

Timing

Symptoms

  • Pain in improvement via VAS assessment
  • Thomsen Provocation Test score for pain
  • Roles and Maudsley pain scores of "good" or "excellent"

Generally measured for up to

12 weeks

Functional improvement

  • Change in Upper Extremity Function Scale (UEFS)
  • Roles and Maudsley function score of "good" or "excellent"
  • Grip strength improvement

Generally measured for up to

12 weeks

Medication Use

Nonuse of pain medication

Generally measured for up to

12 weeks

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

Six randomized, double-blinded, placebo-controlled trials enrolling 808 patients with lateral epicondylitis (tendinitis of the elbow) met inclusion criteria for the TEC Assessment (2004). 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, 1 trial had mixed results, and another large sham-controlled study reported negative results with ESWT.

In the Sonocur trial (2002), 114 patients were randomized to low-energy ESWT or sham ESWT for 3 treatment sessions administered at 1-week intervals. The main outcome measures were percent response on a self-reported pain scale (at least 50% improvement on 0-to-100 VAS) and change in Upper Extremity Function Scale (UEFS) scores. Results for the 2 main outcome measures at 3 months showed greater improvement in the ESWT group. The response rate was 60% in the active treatment group and 29% in the placebo group (p<0.001). UEFS score improved by 51% in the active treatment group and by 30% in the placebo group (p<0.05).

Rompe et al (2004) randomized 78 tennis players to 3 treatments at weekly intervals of low-energy or sham ESWT. Outcomes included pain ratings during wrist extension and Thomsen Provocation Test score, Roles and Maudsley score, UEFS score, grip strength, and satisfaction with a return to activities. At the 3-month follow-up, the ESWT group significantly improved on all outcomes except grip strength compared with placebo. Treatment success (at least a 50% decrease in pain) was 65% for the ESWT group and 28% for the placebo group (p<0.01); and 65% of the ESWT group, compared with 35% of the placebo group, expressed satisfaction with their return to activities (p=0.01).

The OssaTron trial (2000) randomized 183 patients to a single session of high-energy or sham ESWT. Treatment success was a 50% improvement on investigator- and patient-assessed pain using a 0-to-10 VAS and no or rare use of pain medication. At the 8-week follow-up, the ESWT group had a greater rate of treatment success (35%) than the placebo group (22%; p<0.05). The main driver for group differences in treatment success was the investigator-assessed pain (48% vs 29%, respectively; p<0.01); self-assessment of pain (81% vs 70%, respectively; p=0.06) and nonuse of pain medication (81% vs 70%, respectively; p=0.09) improved only marginally.

Haake et al (2002) randomized 272 patients to 3 sessions of low-energy or sham ESWT. Treatment success was defined as achieving a Roles and Maudsley score of 1 or 2 with no need for additional treatments. At 12 weeks, the ESWT success rate was 25.8% and the placebo success rate was 25.4%. The percentage of Roles and Maudsley scores below 3 did not differ between groups at either the 12-week (31.7% ESWT vs 33.1% placebo) or 1-year (65.7% ESWT vs 65.3% placebo) follow-ups. Moreover, the groups did not differ on any of 5 pain assessment measures or on grip strength

Other systematic reviews published since the 2004 Assessment have reached similar conclusions. A Cochrane review by Buchbinder et al (2005) concluded, “there is ‘Platinum’ level evidence [the strongest level of evidence] that shock wave therapy provides little or no benefit regarding pain and function in lateral elbow pain.” A systematic review by Dingemanse et al (2014), which evaluated electrophysical therapies for epicondylitis, found conflicting evidence on the short-term benefits of ESWT. No evidence demonstrated any long-term benefits with ESWT over placebo for epicondylitis treatment.

Randomized Controlled Trials

Several small RCTs on ESWT for lateral epicondylitis have been published since the 2004 TEC Assessment.

Yang et al (2017) published results from an RCT (N=30) comparing RSW plus physical therapy with physical therapy alone in patients with lateral epicondylitis. Outcomes included VAS pain and grip strength. Significant differences were seen in grip strength by 12 weeks of follow-up; the mean difference in grip strength between groups was 7.7 (95% CI, 1.3 to 14.2), favoring RSW. Significant differences in VAS pain (10-point scale) were not detected until 24 weeks of follow-up; the mean difference between groups was -1.8 (95% CI, -3.0 to -0.5), favoring RSW.

A small RCT by Capan et al (2016) comparing RSW (n=28) with sham RSW (n=28) for lateral epicondylitis did not find significant differences between groups in grip strength or function. However, this trial might have been underpowered to detect a difference.

Lizis (2015) compared ESWT with therapeutic ultrasound among 50 patients who had chronic tennis elbow. For most pain measures assessed, the pain was lower in the ESWT group immediately post-treatment and at 3 months, except pain on gripping, which was higher in the ESWT group. While trial results favored ESWT, it had a high risk of bias, in particular, due to lack of blinding of participants and outcome assessors, which make interpretation of results difficult.

Gunduz et al (2012) compared ESWT with 2 active comparators. This trial randomized 59 patients with lateral epicondylitis to ESWT, physical therapy, or a single corticosteroid injection. Outcome measures were VAS pain, grip strength, and pinch strength by dynamometer. The authors reported that VAS pain scores improved significantly in all three groups at all three follow-up time points out to 6 months, but they reported no between-group differences. No consistent changes were reported for grip strength or on ultrasonography. ThisRCT is not included in the summary table because it compares ESWT with corticosteroid injections, and the physical therapy comparator includes ultrasound therapy.

Staples et al (2008) reported on a double-blind controlled trial of ESWT for epicondylitis in 68 patients. Patients were randomized to 3 ESWT treatments or 3 treatments at a sub-therapeutic dose at weekly intervals. There were significant improvements in most of the 7 outcome measures for both groups over 6 months of follow-up but no between-group differences. The authors found little evidence to support the use of ESWT for this indication.

Pettrone and McCall (2005) reported on results from a multicenter, double-blind, randomized trial of 114 patients receiving ESWT in a “focused” manner (2000 impulses at 0.06 mJ/mm2 without local anesthesia) weekly for 3 weeks or placebo. Patients were followed for 12 weeks, and benefit demonstrated with the following outcomes: VAS pain (0-10 points) declined at 12 weeks in the treatment group from 7.4 to 3.8; among placebo patients, from 7.6 to 5.1. A reduction in pain on the Thomsen Provocation Test of at least 50% was demonstrated in 61% of those treated compared with 29% 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, a difference at 12 weeks of 0.9 (95% CI, 0.18 to 1.6). Although this trial found a benefit of ESWT for lateral epicondylitis over 12 weeks, the placebo group also improved significantly; whether the natural history of disease was altered with ESWT is unclear.

Nonrandomized Studies

Nonrandomized observational studies have reported functional outcomes after ESWT for epicondylitis; however, these studies provide limited evidence on the effectiveness of ESWT for lateral epicondylitis compared with other therapies.

Section Summary: Lateral Epicondylitis

The most direct evidence on the use of ESWT to treat lateral epicondylitis comes from multiple small RCTs, which did not consistently show outcome improvements beyond those seen in control groups. The highest quality trials tend to show no benefit, and systematic reviews have generally concluded that the evidence does not support a treatment benefit.

Shoulder Tendinopathy

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative therapy (e.g., physical therapy) and nonsteroidal anti-inflammatory therapy, in patients with shoulder tendinopathy.

The question addressed in this evidence review is: Does the use of ESWT for shoulder tendinopathy improve the net health outcome?

The following PICO were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with shoulder tendinopathy.

Interventions

The therapy being considered is ESWT.

Comparators

Comparators of interest include conservative therapy (eg, physical therapy) and nonsteroidal anti-inflammatory therapy. Comparators are actively managed by orthopedic surgeons, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Table 4. Outcomes of Interest for Individuals with Shoulder Tendinopathy

Outcomes

Details

Timing

Symptoms

  • Pain reduction via VAS assessment
  • American Shoulder and Elbow Surgeons (ASES) scale for pain
  • L'Insalata Shoulder Questionnaire for pain
  • Reduction in size of deposit as assessed by radiograph or ultrasound1

1 week to 1 year

Functional outcomes

  • Constant-Murley Score (CMS)
  • Shoulder Pain And Disability Index (SPADI)
  • American Shoulder and Elbow Surgeons (ASES) scale for function
  • Simple Shoulder Test

1 week to 1 year

Quality of life

Patients' subjective assessment of improvement

1 week to 1 year

1 For studies that assessed calcific tendinitis.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Numerous small RCTs have evaluated ESWT for shoulder tendinopathy, primarily calcific, and noncalcific tendinopathy of the rotator cuff. Several systematic reviews are discussed below, along with select RCTs published after the last systematic review’s literature search cutoff point.

Systematic Reviews

A systematic review and network meta-analysis of RCTs by Wu et al (2017) compared the effectiveness of non-operative treatments for chronic calcific tendinitis. The literature review, conducted through April 2016, identified 14 RCTs (total N=1105 patients) for inclusion. Treatments included in the network meta-analysis were ultrasound-guided needling (UGN), RSW, high-energy FSW (H-FSW), low-energy FSW (L-FSW), ultrasound therapy, and transcutaneous electrical nerve stimulation. Trials either compared the treatments with each other or with sham/placebo. Outcomes were pain (VAS range, 0 [no pain] to 10 [worst pain]), functional assessment (Constant-Murley Score [CMS], up to 100 [asymptomatic]), and calcific deposit change (“no change,” “partial resolution,” or “complete resolution,” assessed by radiograph or ultrasound). Treatments most effective in reducing pain and resolving calcific deposits were UGN, RSW, H-FSW. The only treatment significantly improving function was H-FSW. Table 3 lists the treatments, from most effective to the least effective, by outcome, as determined by network meta-analysis.

Table 5. Ranking of Nonoperative Treatments for Chronic Calcific Tendinitis, by Outcome

Pain Reduction (8 Trials)

Functional Assessment (7 Trials)

Calcific Deposit Change (14 Trials)

Treatment

Difference From Control (95% CrI)

Treatment

Difference From Control (95% CrI)

Treatment

Difference From Control (95% CrI)

UGN

8.0 (4.9 to 11.1)

H-FSW

25.1 (10.3 to 40.0)

UGN

6.8 (3.8 to 9.9)

RSW

6.1 (3.9 to 8.3)

TENS

8.7 (-13.5 to 30.9)

RSW

6.2 (3.2 to 9.1)

H-FSW

4.2 (2.0 to 6.4)

L-FSW

7.6 (-7.2 to 22.5)

H-FSW

2.4 (1.5 to 3.4)

TENS

3.2 (-0.1 to 6.5)

Ultrasound

3.3 (-15.0 to 21.6)

Ultrasound

2.1 (0.4 to 3.8)

L-FSW

1.9 (-0.4 to 4.3)

TENS

1.9 (-0.8 to 4.6)

Ultrasound

1.1 (-1.7 to 3.9)

L-FSW

1.2 (0.1 to 2.2)

Adapted from Wu et al (2017).
CrI: credible interval; H-FSW: high-energy focused extracorporeal shockwave; L-FSW: low-energy focused extracorporeal shockwave; RSW: radial extracorporeal shockwave; TENS: transcutaneous electrical nerve stimulation; UGN: ultrasound-guided needling.

A systematic review and network meta-analysis of RCTs by Arirachakaran et al (2017) evaluated ESWT, ultrasound-guided percutaneous lavage (UGPL), sub-acromial corticosteroid injection (SAI), and combined treatments for rotator cuff calcific tendinopathy. The literature search, conducted through September 2015, identified 7 RCTs for inclusion. Six of the trials had ESWT as 1 treatment arm, with the following comparators: placebo (4 trials), UGPL plus ESWT (1 trial), and UGPL plus SAI (1 trial). One trial compared UGPL plus SAI with SAI alone. Outcomes were CMS (5 trials), VAS pain (5 trials), and size of calcium deposit (4 trials). Network meta-analysis results are summarized below:

  • VAS pain:
    • ESWT, UGPL plus SAI, and SAI alone were more effective in reducing pain than placebo
    • Compared with each other, ESWT, UGPL plus SAI, and SAI alone did not differ statistically
  • CMS:
    • ESWT was statistically more effective than placebo
    • No other treatment comparisons differed statistically
  • Size of calcium deposit:
    • UGPL plus SAI was statistically more effective than placebo and SAI alone
    • ESWT was statistically better than SAI alone, but not more effective than placebo.

In a systematic review by Yu et al (2015) of RCTs of various passive physical modalities for shoulder pain, which included 11 studies considered at low risk of bias, 5 studies reported on ESWT. Three, published from 2003 to 2011, assessed calcific shoulder tendinopathy, including 1 RCT comparing high-energy ESWT with low-energy ESWT (N=80), 1 RCT comparing RSW with sham ESWT (N=90), and 1 RCT comparing high-energy ESWT with low-energy ESWT and sham ESWT (N=144). All 3 trials reported statistically significant differences between groups for change in VAS score for shoulder pain.

In another meta-analysis of RCTs comparing high-energy with low-energy ESWT, Verstraelen et al (2014) evaluated 5 studies (total N=359 patients) on calcific shoulder tendinitis. Three 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 ratio, 3.4; 95% CI, 1.35 to 8.58; p=0.009). The pooled analysis could not be performed for 6-month follow-up data.

Bannuru et al (2014) published a systematic review of RCTs comparing high-energy ESWT with placebo or low-energy ESWT for the treatment of calcific or non-calcific shoulder tendinitis. All 7 studies comparing ESWT with placebo for calcific tendinitis 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. Eight studies comparing high- with low-energy ESWT for calcific tendinitis did not demonstrate significant improvements in pain outcomes, although shoulder function improved. Trials were reported to be of low quality with a high risk of bias.

Huisstede et al (2011) published a systematic review of RCTs that included 17 RCTs on calcific (n=11) and noncalcific (n=6) tendinopathy of the rotator cuff. Moderate-quality evidence was found for the efficacy of ESWT vs 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.

Randomized Controlled Trials

An RCT by Kvalvaag et al (2017) randomized patients with sub-acromial shoulder pain to RSW plus supervised exercise (n=74) or to sham treatment plus supervised exercise (n=69). Patients received 4 treatments of RSW or sham at 1-week intervals. After 24 weeks of follow-up, both groups improved from baseline, with no significant differences between groups. Within a pre-specified subgroup of patients with calcification in the rotator cuff, there was a statistically significant improvement in the group receiving ESWT compared with sham treatment (p=0.18). After 1 year, there was no statistically significant difference in improvements between RSW and sham when groups were analyzed together and separately.

An RCT by Kim et al (2016) evaluated the use of ESWT in patients with calcific tendinitis. All patients received nonsteroidal anti-inflammatory drugs, transcutaneous electrical nerve stimulation, and ultrasound therapy (N=34). A subset (n=18) also received ESWT, 3 times a week for 6 weeks. CMS was measured at 2, 6, and 12 weeks. Both groups improved significantly from baseline. The group receiving ESWT improved significantly more than the control group; however, the lack of a sham control limits interpretability of results.

The following are select trials included in the systematic reviews described above.

Kim et al (2014) compared UGPL plus SAI with ESWT in patients who had unilateral calcific shoulder tendinopathy and ultrasound-documented calcifications of the supraspinatus tendon. Sixty-two patients were randomized. Fifty-four patients were included in the data analysis (8 subjects were lost to follow-up). ESWT was performed for 3 sessions once weekly. The radiologic evaluation was blinded, although it was not specified whether evaluators for pain and functional outcomes were blinded. After an average follow-up of 23.0 months (range, 12.1-28.5 months), functional outcomes improved in both groups: for the UGPL plus SAI group, scores on the American Shoulder and Elbow Surgeons scale improved from 41.5 to 91.1 (p=0.001) and on the Simple Shoulder Test from 38.2% to 91.7% (p=0.03). In the ESWT group, scores on the American Shoulder and Elbow Surgeons scale improved from 49.9 to 78.3 (p=0.026) and on the Simple Shoulder Test from 34.0% to 78.6% (p=0.017). Similarly, VAS pain scores improved from baseline to the last follow-up in both groups. At the last follow-up visit, calcium deposit size was smaller in the UGPL plus SAI group (0.5 mm) than in the ESWT group (5.6 mm; p=0.001).

An example of a high-energy vs low-energy trial is that by Schofer et al (2009), which assessed 40 patients with rotator cuff tendinopathy. An increase in function and reduction of pain were found in both groups (p<0.001). Although improvement in the 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, or at 1 year post-treatment.

At least 1 RCT has evaluated patients with bicipital tendinitis of the shoulder. This trial by Liu et al (2012) randomized 79 patients with tenosynovitis to ESWT or to sham treatment. ESWT was given for 4 sessions over 4 weeks. Outcomes were measured at up to 12 months using 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 (4.24 units) than for the sham group (0.47 units; p<0.001). There were similar improvements in the L’Insalata Shoulder Questionnaire, with scores in the ESWT group improving by 22.8 points.

Section Summary: Shoulder Tendinopathy

A number of small RCTs, summarized in several systematic reviews and meta-analyses, have evaluated the use of ESWT to treat shoulder tendinopathy. A network meta-analyses focused on 3 outcomes: pain reduction, functional assessment, and change in calcific deposits. One network meta-analysis separated trials using H-FSW, L-FSW, and RSW. It reported that the most effective treatment for pain reduction was UGN, followed by RSW and H-FSW. The only treatment showing a benefit in functional outcomes was H-FSW. For the largest change in calcific deposits, the most effective treatment was UGN, followed by RSW and H-FSW. Although some trials have reported a benefit for pain and functional outcomes, particularly for high-energy ESWT for calcific tendinopathy, many available trials have been considered poor quality. More high-quality trials are needed to determine whether ESWT improves outcomes for shoulder tendinopathy.

Achilles Tendinopathy

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative therapy (e.g., physical therapy) and nonsteroidal anti-inflammatory therapy, in patients with Achilles tendinopathy.

The question addressed in this evidence review is: Does the use of ESWT for Achilles tendinopathy improve the net health outcome?

The following PICO were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with Achilles tendinopathy.

Interventions

The therapy being considered is ESWT.

Comparators

Comparators of interest include conservative therapy (e.g., physical therapy) and nonsteroidal anti-inflammatory therapy. Comparators are actively managed by orthopedic surgeons, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

 Table 6. Outcomes of Interest for Individuals with Achilles Tendinopathy

Outcomes

Details

Timing

Symptoms

  • Pain improvement via VAS assessment
  • Victorian Institute of Sports Assessment-Achilles (measures redness, warmth, swelling, tenderness, edema)
  • American Orthopedic Foot And Ankle Score (AOFAS) for pain1
  • Roles and Maudsley pain scores of "good" or "excellent"

4 weeks to > 1 year

Functional outcomes

  • Constant-Murley Score (CMS)
  • Shoulder Pain And Disability Index (SPADI)
  • American Shoulder and Elbow Surgeons (ASES) scale for function
  • Simple Shoulder Test

4 weeks to > 1 year

Quality of life

Patients' subjective assessment of improvement

4 weeks to > 1 year

1 Researchers concluded that AOFAS might not be appropriate to evaluate treatment of Achilles tendinopathy.

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

Mani-Babu et al (2015) reported on results of a systematic review of studies evaluating ESWT for lower-limb tendinopathies. Reviewers included 20 studies, 11 of which evaluated ESWT for Achilles tendinopathy (5 RCTs, 4 cohort studies, 2 case-control studies). In the pooled analysis, reviewers reported that evidence was limited, but showed that ESWT was associated with greater short-term (<12 months) and long-term (>12 months) improvements in pain and function compared with non-operative treatments, including rest, footwear modifications, anti-inflammatory medication, and gastrocnemius-soleus stretching and strengthening. Reviewers noted that findings from RCTs of ESWT for Achilles tendinopathy were contradictory, but that some evidence supported short-term improvements in function with ESWT. Reviewers warned that results be interpreted cautiously due to the heterogeneity in patient populations (age, insertional vs mid-portion Achilles tendinopathy) and treatment protocols.

Al-Abbad and Simon (2013) conducted a systematic review of 6 studies on ESWT for Achilles tendinopathy. Selected for the review were 4 small RCTs and 2 cohort studies. Satisfactory evidence was found in 4 studies demonstrating the effectiveness of ESWT in the treatment of Achilles tendinopathy at 3 months. However, 2 RCTs found no significant difference between ESWT and placebo in the treatment of Achilles tendinopathy. These trials are described next.

Randomized Controlled Trials

Lynen et al (2017) published results from an RCT comparing 2 peri-tendinous hyaluronan injections (n=29) with 3 ESWT applications (n=30) for the treatment of Achilles tendinopathy. The primary outcome was percent change in VAS pain score at the 3-month follow-up. Other measurements included the Victorian Institute of Sports Assessment,-Achilles, clinical parameters (redness, warmth, swelling, tenderness, edema), and patients’ and investigators’ impression of treatment outcome. Follow-up was conducted at 4 weeks, 3 months, and 6 months. Pain decreased in both groups from baseline, though percent decrease in pain was statistically larger in the hyaluronan injections group than in the ESWT group at all follow-up time points. Secondary outcomes also showed larger improvements in the hyaluronan injections group.

The 2 trials described next were included in the systematic reviews.

Rasmussen et al (2008) reported on a single-center, double-blind controlled trial with 48 patients, half randomized after 4 weeks of conservative treatment to 4 sessions of active RSW and half to sham ESWT. The primary end point was AOFAS score measuring function, pain, and alignment and VAS pain score. AOFAS score after treatment increased from 70 to 88 in the ESWT group and from 74 to 81 in the control (p=0.05). The pain was reduced in both groups, with no statistically significant difference between groups. The authors suggested that the AOFAS might not be appropriate to evaluate treatment of Achilles tendinopathy.

Costa et al (2005) reported on a randomized, double-blind, placebo-controlled trial of ESWT for chronic Achilles tendon pain treated monthly for 3 months. The trial randomized 49 participants and was powered to detect a 50% reduction in VAS pain scores. No differences in pain relief at rest or during sports participation were found at 1 year. Two older ESWT-treated participants experienced tendon ruptures.

Nonrandomized Studies

Lee et al (2017) studied factors that affect immediate (1 week after last treatment) and long-term (mean 26 months after last treatment) success of ESWT for chronic refractory Achilles tendinopathy. Patients with “poor” or “fair”’ grades on Roles and Maudsley assessment after conservative treatment for Achilles tendinopathy (N=33 patients, 45 feet) were treated weekly with ESWT to a maximum of 12 sessions. Success was defined as Roles and Maudsley scores of “good” or “excellent.” Thirty-two (71%) feet were considered successfully treated at the long-term follow-up assessment. Factors predicting immediate success included retro-calcaneal enthesophyte on x-ray, the presence of abnormal ultrasonography echogenicity, and shorter duration of soreness after first ESWT. The only factor predicting long-term success was the shorter duration of soreness after first ESWT.

Wu et al (2016) compared the effect of ESWT on insertional Achilles tendinopathy with or without Haglund deformity. A total of 67 patients were enrolled, 30 with and 37 without the deformity. Patients received weekly ESWT for 5 weeks. The Victorian Institute of Sports Assessment-Achilles scores improved significantly in both groups, regardless of the presence or absence of the deformity.

Section Summary: Achilles Tendinopathy

Two systematic reviews of RCTs and an RCT published after the systematic reviews, and nonrandomized studies have evaluated the use of ESWT for Achilles tendinopathy. In the most recent systematic review, a pooled analysis found that ESWT reduced both short- and long-term pain compared with non-operative treatments, although these reviewers warned that results were inconsistent across the RCTs and that there was heterogeneity across patient populations and treatment protocols. An RCT published after the systematic review compared ESWT with hyaluronan injections and reported improvements in both treatment groups, although significantly higher in the injection group.

Patellar Tendinopathy

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as conservative therapy (eg, physical therapy) and nonsteroidal anti-inflammatory therapy, in patients with patellar tendinopathy.

The question addressed in this evidence review is: Does the use of ESWT for patellar tendinopathy improve the net health outcome?

The following PICO were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with patellar tendinopathy.

Interventions

The therapy being considered is ESWT.

Comparators

Comparators of interest include conservative therapy (eg, physical therapy) and nonsteroidal anti-inflammatory

therapy. Comparators are actively managed by orthopedic surgeons, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Table 7. Outcomes of Interest for Individuals with Patellar Tendinopathy

Outcomes

Details

Timing

Symptoms

  • Pain reduction via VAS assessment
  • Patellar tendon thickness
  • Victorian Institute of Sports Assessment-Patellar Tendon
  •  McGill Pain Questionnaire
  • Roles and Maudsley score for pain
  • Likert scale/numerical rating scale for pain
  • Swelling

< 1 month to 1 year

Functional outcomes

  • Range of motion
  • Knee Outcome Survey Activities of Daily Living
  • Vertical jump test
  • Roles and Maudsley score for function
  • International Knee Documentation Committee scale

< 1 month to 1 year

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

Van Leeuwen et al (2009) conducted a literature review to study the effectiveness of ESWT for patellar tendinopathy and to draft a treatment protocol. Reviewers found that most of the 7 selected studies had methodologic deficiencies, small numbers and/or short follow-up periods, and variation in treatment parameters. Reviewers concluded ESWT appears to be a safe and promising treatment but could not recommend a treatment protocol.

In the systematic review of ESWT for lower-extremity tendinopathies (previously described), Mani-Babu et al (2015) identified 7 studies of ESWT for patellar tendinopathy (2 RCTs, 1 quasi-RCT, 1 retrospective cross-sectional study, 2 prospective cohort studies, 1 case-control study). The 2 RCTs came to different conclusions: one found no difference in outcomes between ESWT and placebo at 1, 12, or 22 weeks, whereas the other found improved outcomes on vertical jump test and Victorian Institute of Sport Assessment–Patellar scores at 12 weeks with ESWT compared with placebo. Two studies that evaluated outcomes beyond 24 months found ESWT comparable to patellar tenotomy surgery and better than non-operative treatments.

Randomized Controlled Trials

An RCT by Thijs et al (2017) compared the use of ESWT plus eccentric training (n=22) with sham shock wave therapy plus eccentric training (n=30) for the treatment of patellar tendinopathy. Patients were physically active with a mean age 28.6 years (range, 18-45 years). ESWT and sham shock wave were administered in 3 sessions, once weekly. Patients were instructed to perform eccentric exercises, 3 sets of 15 repetitions twice daily for 3 months on a decline board at home. Primary outcomes were Victorian Institute of Sport Assessment–Patellar score and pain score during functional knee loading tests (10 decline squats, 3 single leg jumps, 3 vertical jumps). Measurements were taken at baseline, 6, 12, and 24 weeks. There were no statistically significant differences between the ESWT and sham shock wave groups for any of the primary outcome measurements at any follow-up except for the vertical jump test at week 6.

In an RCT of patients with chronic patellar tendinopathy (N=46), despite at least 12 weeks of nonsurgical management, Smith and Sellon (2014) reported that improvements in pain and functional outcomes were significantly greater (p<0.05) with plasma-rich protein injections than with ESWT at 6 and 12 months, respectively.

Nonrandomized Studies

Williams et al (2017) investigated whether the location of the patellar tendinopathy impacted the response to ESWT. All 40 patients underwent a magnetic resonance imaging scan. The scan showed that 20 patients had tendon involvement and 20 patients had retropatella fat pad extension. All patients underwent RSW. If there was no improvement of symptoms following RSW, patients were offered arthroscopic débridement. Seventeen of the 20 patients with tendon involvement responded to the RSW and needed no further treatment. None of the patients with retropatella fat extension responded to RSW.

Section Summary: Patellar Tendinopathy

The trials on the use of ESWT for patellar tendinopathy have reported inconsistent results and were heterogeneous in treatment protocols and lengths of follow-up.  One nonrandomized study has suggested that the location of the patellar tendinopathy might impact the response to ESWT.

Medial Tibial Stress Syndrome

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as icing or support, in patients with medial tibial stress syndrome.

The question addressed in this evidence review is: Does the use of ESWT for medial tibial stress syndrome improve the net health outcome?

The following PICO were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with medial tibial stress syndrome.

Interventions

The therapy being considered is ESWT.

Comparators

The comparator of interest is conservative therapy (e.g., icing, support). Comparators are actively managed by orthopedic surgeons, physical therapists, and primary care providers in an outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Table 8. Outcomes of Interest for Individuals with Medial Tibial Stress Syndrome

Outcomes

Details

Timing

Symptoms

  • Pain reduction via VAS assessment
  • Patellar tendon thickness
  • Victorian Institute of Sports Assessment-Patellar Tendon
  •  McGill Pain Questionnaire
  • Roles and Maudsley score for pain
  • Likert scale/numerical rating scale for pain
  • Swelling

< 1 month to 1 year

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Newman et al (2017) published a double-blind, sham-controlled randomized trial on the use of ESWT for the treatment of 28 patients with medial tibial stress syndrome (MTSS; commonly called shin splints). Enrolled patients had running-related pain for at least 21 days confined to the posteromedial tibia, lasting for hours or days after running. Patients received treatments (ESWT or sham) at weeks 1, 2, 3, 5, and 9 and were instructed to keep activity levels as consistent as possible. At week 10 measurements, there was no difference between the treatment and control groups in self-reported pain during bone pressure, muscle pressure, or during running. There was no difference in pain-limited running distances between groups.

Rompe et al (2010) published a report on the use of ESWT in medial tibial stress syndrome. In this nonrandomized cohort study, 47 patients with MTSS for at least 6 months received 3 weekly sessions of RSW 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 success rate of 64% (30/47) in the treatment group compared with 30% (14/47) in the control group. In a comment, Barnes (2010) raised several limitations of this nonrandomized study, including the possibility of selection bias.

Section Summary: Medial Tibial Stress Syndrome

Evidence for the use of ESWT for MTSS includes a small RCT and a small nonrandomized study. The RCT showed no differences in self-reported pain measurements between study groups. The nonrandomized trial reported improvements with ESWT, but selection bias limits the strength of the conclusions.

Osteonecrosis of the Femoral Head

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on existing therapies, such as medication (eg, alendronate) or hip arthroplasty, in patients with osteonecrosis of the femoral head.

The question addressed in this evidence review is: Does the use of ESWT for osteonecrosis of the femoral head improve the net health outcome?

The following PICOTs were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with osteonecrosis of the femoral head.

Interventions

The therapy being considered is ESWT.

Comparators

Comparators of interest include medication and hip arthroplasty. Comparators are actively managed by orthopedic surgeons, physical therapists, and primary care providers in an inpatient (for hip arthroplasty) or outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

Table 9. Outcomes of Interest for Individuals with Osteonecrosis of the Femoral Head

Outcomes

Details

Timing

Symptoms

  • Pain reduction via VAS assessment
  • Harris Hip Scores for pain
  • Radiographic reduction of bone marrow edema on magnetic resonance imaging

3 months to > 24 months

Functional outcomes

Harris Hip Scores for function

3 months to > 24 months

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded.

Systematic Reviews

In their meta-analysis, Hao et al (2018) compared the effectiveness of ESWT with other treatment strategies in improving pain scores and Harris Hip Score (HHS) for patients with osteonecrosis of the femoral head (ONFH). Their search for interventional studies published in Chinese or English yielded 4 articles with a total of 230 patients, most of whom were in stages I–III of ONFH. Before treatment, no significant differences in pain scores (P=0.1328) and HHSs (P=0.287) were found between the ESWT group (n=130) and control group (n=110). Post-treatment, the ESWT group reported significantly higher improvement in pain scores than the control group (SMD, -2.1148; 95% CI, -3.2332 to -0.9965; Z=3.7063; P=0.0002), as well as higher HHSs (SMD, 2.1377; 95% CI, 1.2875–2.9880; Z=4.9281 ; P<0.001). However, the analysis revealed no significant improvements in pain scores before and after treatment (P=0.005), but it did reveal significant improvements in the HHS (P<0.001). Patient follow-up time across studies ranged from 3 to 25 months. This analysis has several limitations: only one

RCT is included out of four studies; small sample size results in more pronounced heterogeneity between studies; the studies are of poor quality; publication bias was detected for the HHS after treatment; and only two studies reported pain scores.

A systematic review by Zhang et al (2016) evaluated evidence on the use of ESWT for osteonecrosis of the femoral head. The literature search, conducted through July 2016, identified 17 studies for inclusion (9 open-label studies, 4 RCTs, 2 cohort studies, 2 case reports). Study quality was assessed using the Oxford Centre of Evidence-Based Medicine Levels of Evidence (I = highest quality and V = lowest quality, and each level can be subdivided a through c). Four studies were Ib, 2 studies were IIb, and 11 studies were IV. Most studies included patients with Association Research Circulation Osseous categories I through III (out of 5 stages of osteonecrosis). Outcomes in most studies were VAS pain score and Harris Hip Score, a composite measure of pain and hip function. Reviewers concluded that ESWT can be a safe and effective method to improve motor function and relieve pain, particularly in patients with early-stage osteonecrosis. Studies that included imaging results showed that bone marrow edema could be relieved, but that necrotic bone was not reversed. Evidence limitations included the heterogeneity of treatment protocol (numbers of sessions, energy intensities, focus sizes differed among studies) and most studies were of low quality.

A systematic review of ESWT for osteonecrosis (avascular necrosis) of the femoral head was conducted by Alves et al (2009). The literature search conducted through 2009 identified 5 articles, all from non-U.S. sites (2 RCTs, 1 comparative study, 1 open-label study, 1 case report; total N=133 patients). Of the 2 RCTs, 1 randomized 48 patients to the use of concomitant alendronate; both arms received ESWT treatments and therefore ESWT was not a comparator. The other RCT compared ESWT with a standard surgical procedure. All results noted a reduction in pain during the trial, which the authors attributed to ESWT. However, reviewers, when discussing the limitations of the available evidence, noted a lack of double-blind designs, small numbers of patients enrolled, short follow-up times, and nonstandard interventions (e.g., energy level, the number of treatments).

Nonrandomized Studies

An example of a comparative study included in the Zhang review was published by Chen et al (2009). In this study of 17 patients with bilateral hip osteonecrosis, 1 hip was treated with total hip arthroplasty while the other was treated with ESWT. Each patient was evaluated at baseline and after treatment using VAS score for pain and Harris Hip Score. There was a significant reduction in scores before and after both treatments. Hips treated with ESWT were also evaluated for radiographic reduction of bone marrow edema on magnetic resonance imaging, which also appeared to be reduced. A comparison of ESWT data with total hip arthroplasty data showed the magnitude of improvement was greater for the ESWT-treated hips. However, treatment allocations were not randomized. The hip with the greater degree of disease was treated with surgery in each case. Moreover, the time between hip interventions within the same patient averaged 17.3 months (range, 6-36 months); in all but 1 case, surgery preceded ESWT. Conclusions about the superiority of either intervention could not be made.

Han et al (2016) evaluated the effect of 2 energy intensities of ESWT on early-stage (the Association Research Circulation Osseous categories I through III) osteonecrosis of the femoral head. One arm of the trial (n=15) received 1000 shocks per session with an energy flux density of 0.12 mJ/mm2 and the other arm (n=15) received 1000 shocks per session with an energy flux density of 0.32 mJ/mm2. Outcomes included VAS pain and Harris Hip Score; they were measured at baseline, and at 1, 3, and 6 months. Pain significantly decreased and hip functional scores significantly increased in both treatment groups at each follow-up measurement. The authors concluded that lower energy levels of ESWT might be effective in treating early-stage osteonecrosis of the femoral head.

Section Summary: Osteonecrosis of the Femoral Head

The body of evidence on the use of ESWT for osteonecrosis of the femoral head consists of 2 systematic reviews of small, mostly nonrandomized studies. Many of the studies were low quality and lacked comparators. While most studies reported favorable outcomes with ESWT, limitations such as the heterogeneity in the treatment protocols, patient populations, and lengths of follow-up make conclusions on the efficacy of ESWT for osteonecrosis uncertain.

Nonunion or Delayed Union of Acute Fracture

Clinical Context and Therapy Purpose

The purpose of ESWT is to provide a treatment option that is an alternative to or an improvement on surgical therapy for patients with acute fracture nonunion or delayed union.

The question addressed in this evidence review is: Does the use of ESWT for acute fracture nonunion or delayed union improve the net health outcome?

The following PICOTs were used to select literature to inform this review.

Patients

The relevant population of interest is individuals with acute fracture nonunion or delayed union.

Interventions

The therapy being considered is ESWT.

Comparators

The comparator of interest is surgical therapy. This comparator is actively managed by orthopedic surgeons in an inpatient or outpatient clinical setting.

Outcomes

The general outcomes of interest are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity.

 Table 10. Outcomes of Interest for Individuals with Acute Fracture Nonunion or Delayed Union

Outcomes

Details

Timing

Symptoms

  • Pain reduction via VAS assessment
  • Radiographic evidence of healing

6 months to 12 months

Functional outcomes

Weight-bearing status

6 months to 12 months

Study Selection Criteria

Methodologically credible studies were selected using the following principles:

  1. To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs;
  2. In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.
  3. To assess longer term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

Studies with duplicative or overlapping populations were excluded

Systematic Reviews

Zelle et al (2010) published a review of the English and German medical literature on ESWT for the treatment of fractures and delayed union/nonunion. Limiting the review to studies with more than 10 patients, reviewers identified 10 case series and 1 RCT. The number of treatment sessions, energy levels, and definitions of nonunion varied across studies; union rates after the intervention were likewise defined heterogeneously, ranging from 40.7% to 87.5%. Reviewers concluded the overall quality of evidence was conflicting and of poor quality.

Randomized Controlled Trials

The RCT in the Zelle et al (2010) review reported on the     use of ESWT in acute long bone fractures. Wang et al (2007) randomized 56 trauma patients 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. Patients were evaluated for pain and percent weight-bearing capability by an independent, blinded evaluator at 3, 6, and 12 months. Radiographs taken at these same intervals were evaluated by a radiologist blinded to study group assignment. Both groups showed significant improvements in pain scores and weight-bearing status. Between-group comparisons of VAS pain and weight bearing favored ESWT patients at each interval. At 6 months, patients who had received ESWT had VAS scores of 1.2 compared with 2.5 in the control group (p<0.001); mean percentage of weight bearing at 6 months was 87% and 78%, respectively (p=0.01). Radiographic evidence of union at each interval also favored the ESWT group. At 6 months, 63% (17/27) of the treatment group achieved fracture union compared with 20% (6/30) in the control group (p<0.001). The authors noted some limitations of the trial: the small number of patients enrolled, surgeries performed by multiple surgeons, and questions about the adequacy of randomization.

RCTs published after the review are described next. They include the multicenter RCT by Cacchio et al (2009), which randomized 126 patients into 3 groups: low-energy ESWT, high-energy ESWT therapy, or surgery. Nonunion fractures were defined as at least 6 months without evidence of radiographic healing. The primary end point was radiographic evidence of healing. Secondary end points were pain and functional status, collected by blinded evaluators. Neither patients nor treating physicians were blinded. At 6 months, healing rates in the low-energy ESWT, high-energy ESWT, and surgical arms were similar (70%, 71%, 73%, respectively). All groups’ healing rates improved at 12- and 24-month follow-ups, without significant between-group differences. Secondary end points of pain and disability were also similar. Lack of blinding might have led to differing levels of participation in other aspects of the treatment protocol.

A study by Zhai et al (2016) evaluated the use of human autologous bone mesenchymal stem cells combined with ESWT for the treatment of nonunion long bones. Nonunion was defined as 6 or more months post fracture with no evidence of additional healing in the past 3 months. Patients were randomized to high-energy ESWT (n=31) or human autologous mesenchymal stem cells plus ESWT (n=32). ESWT was administered every 3 days, 4 times for upper-limb nonunion and 5 times for lower-limb nonunion. Outcome measures were no pain, no abnormal mobility, an x-ray showing blurred fracture line, and upper-limb holding 1 kg for 1 minute or lower-limb walking for 3 minutes. Success was defined as meeting all 4 criteria at 12 months. The human autologous stem cells plus ESWT group experienced an 84% healing rate. The ESWT alone group experienced a 68% healing rate (p<0.05).

Section Summary: Nonunion or Delayed Union of Acute Fracture

The evidence on the use of ESWT for the treatment of fractures or for fracture nonunion or delayed union includes several relatively small RCTs with methodologic limitations (e.g., heterogeneous outcomes and treatment protocols), along with case series. The available evidence does not permit conclusions on the efficacy of ESWT in fracture nonunion, delayed union, or acute long bone fractures.

Spasticity

Systematic Reviews

Lee et al (2014) conducted a meta-analysis of studies evaluating ESWT for patients with spasticity secondary to a brain injury. Studies included evaluated ESWT as sole therapy and reported pre- and post-intervention Modified Ashworth Scale (MAS) scores. Five studies were selected, 4 examining spasticity in the ankle plantar flexor and one examining spasticity in the wrist and finger flexors; 3 studies evaluated post-stroke spasticity and 2 evaluated spasticity associated with cerebral palsy. Immediately post-ESWT, MAS scores improved significantly compared with baseline (standardized mean difference, -0.792; 95% CI, -1.001 to -0.583; p<0.001). Four weeks post-ESWT, MAS scores continued to demonstrate significant improvements compared with baseline (standardized mean difference, -0.735; 95% CI, -0.951 to -0.519; p<0.001). A strength of this meta-analysis was its use of a consistent and well-definable outcome measure. However, the MAS does not account for certain clinically important factors related to spasticity, including pain and functional impairment.

Randomized Controlled Trials

The efficacy and safety of RSW in the treatment of spasticity in patients with cerebral palsy were examined in a small European RCT. As reported by Vidal et al (2011), the 15 patients in this trial 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 post-treatment. The blinded evaluation showed significant differences between the ESWT and placebo groups for range of motion and Ashworth Scale score. For the group in which only the spastic muscle was treated, there was a 1-point improvement on the Ashworth Scale (reported significant vs placebo); for the group with both spastic agonist and antagonist muscles treated, there was a 0.5-point improvement (p=NS vs placebo); and for the placebo group, there was no change. The significant improvements were maintained at 2 months post-treatment, but not at 3 months.

Noncomparative Studies

Daliri et al (2015) evaluated the efficacy of a single session of ESWT for the treatment of post-stroke wrist flexor spasticity in a single-blinded trial in which each patient received sham control and active stimulation. Fifteen patients at a mean 30 months post-stroke 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 MAS score 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. MAS scores and Brunnstrom Recovery Stage scores did not improve after sham treatment. MAS scores improved significantly from baseline (mean, 3) to post active treatment (mean scores, 2, 2, and 2 immediately post-therapy, 1 week post-therapy, and 5 weeks post-therapy, respectively; p<0.05). The H¬max/Mmax¬ ratio improved from 2.30 before therapy to 1 the week after active ESWT (p=0.047). Brunnstrom scores did not significantly improve after active ESWT. Given the lack of a control group, this study provides limited evidence on the comparative efficacy of ESWT for post-stroke spasticity.

Santamato et al (2014) evaluated outcomes after a single session of ESWT for post-stroke plantar flexor spasticity (equinus foot) in 23 subjects. Subjects with gastrocnemius/soleus Heckmann scores on ultrasound from I to III (maximum score, IV [very high muscle echo intensity due to fat and fibrosis]) had significant improvements in MAS scores from baseline to immediately post-ESWT (3.5 to 2.1, p<0.01) and from baseline to 30 days post-ESWT (3.5 to 2.6, p<0.05). Those with a Heckmann score of IV showed improvements in MAS scores from baseline to immediately post-ESWT (4.7 to 3.3, p<0.05), but 30-day scores did not differ significantly from baseline. Results were similar for passive ankle dorsiflexion scores.

Section Summary: Spasticity

A relatively small body of evidence, with limited RCT evidence, is available on the use of ESWT for spasticity. Several studies have demonstrated improvements in spasticity measures after ESWT. More controlled trials in larger populations are needed to determine whether ESWT leads to clinically meaningful improvements in pain and/or functional outcomes for spasticity.

ESWT for Other Conditions

ESWT has been investigated in small studies for other conditions, including coccydynia in a case series of 2 patients, painful neuromas at amputation sites in an RCT assessing 30 subjects, and chronic distal biceps tendinopathy in a case-control study of 48 patients.

The systematic review of ESWT for lower-extremity tendinopathies (previously described) by Mani-Babu et al (2015) 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.51 ESWT was associated with some benefits compared with placebo or home therapy.

Chronic Pain Syndrome

In a small study of 34 patients, Zimmermann et al (2008) investigated the use of ESWT for patients with CPPS for at least three months.  ESWT was administered using a perineal approach with two different standard ESWT devices with and without an ultrasonographic positioning system. The study showed statistically significant improvements in pain and quality of life after EWST. Voiding conditions were temporarily improved but with no statistical significance. There are no reference factors for the treatment of CPPS from comparable clinical studies. It is not possible to devise treatment parameters and target criteria. There was no control group for this study. Follow-up was limited to a 12 week period and it is not known if patients will have a subsequent recurrence of the disorder.

Summary of Evidence

For treatment of plantar fasciitis using ESWT, numerous RCTs were identified, including several well-designed double-blinded RCTs, that evaluated ESWT for the treatment of plantar fasciitis. Seven systematic reviews and meta-analyses have been conducted, covering a total of 27 studies. Pooled results were inconsistent. Some meta-analysis reported that ESWT reduced pain, while others reported nonsignificant pain reduction. Reasons for the differing results included lack of uniformity in the definitions of outcomes and heterogeneity in ESWT protocols (focused vs radial, low- vs high-intensity/energy, number and duration of shocks per treatment, number of treatments, and differing comparators). Some studies reported significant benefits in pain and functional improvement at three months, but it is not evident that the longer-term disease natural history is altered with ESWT. Currently, it is not possible to conclude definitively that ESWT improves outcomes for patients with plantar fasciitis.

For individuals who have lateral epicondylitis who receive ESWT, the evidence includes small RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Overall, although some RCTs have demonstrated benefits in pain and functional outcomes associated with ESWT, the limited amount of high-quality RCT evidence precludes conclusions about the efficacy of ESWT for lateral epicondylitis. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have shoulder tendinopathy who receive ESWT, the evidence includes 2 network meta-analyses as well as several systematic reviews and meta-analyses of RCTs. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The network meta-analyses focused on 3 outcomes: pain reduction, functional assessment, and change in calcific deposits. One network meta-analysis separated trials using high-energy focused ESWT (H-FSW), low-energy ESWT, and radial ESWT (RSW). This analysis reported the most effective treatment for pain reduction was ultrasound-guided needling, followed by RSW and H-FSW. The only treatment showing a benefit in functional outcomes was H-FSW. For the largest change in calcific deposits, the most effective treatment was ultrasound-guided needling, followed by RSW, then H-FSW. Many of the RCTs were judged of poor quality. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have Achilles tendinopathy who receive ESWT, the evidence includes systematic reviews of RCTs, an RCT published after the systematic review, and nonrandomized studies. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. In the most recent systematic review, a pooled analysis found that ESWT reduced both short- and long-term pain compared with non-operative treatments, although reviewers warned that results were inconsistent across the RCTs and that there was heterogeneity across studies (e.g., patient populations, treatment protocols). An RCT published after the systematic review compared ESWT with hyaluronan injections and reported improvements in both treatment groups, although the improvements were significantly higher in the injection group. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have patellar tendinopathy who receive ESWT, the evidence includes systematic reviews of small studies, an RCT not included in the systematic reviews, and a nonrandomized study. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The studies reported inconsistent results. Many had methodologic deficiencies such as small numbers, short follow-up periods, and heterogeneous treatment protocols. Results from a nonrandomized study suggested that the location of the patellar tendinopathy might impact the response to ESWT (patients with retro-patella fat extension did not respond to RSW compared with patients with tendon involvement). The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have medial tibial stress syndrome who receive ESWT, the evidence includes a small RCT and a small nonrandomized cohort study. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. The RCT reported no difference in self-reported pain between study groups. The cohort study reported improvements with ESWT, although selection bias impacted the strength of the conclusions. The available evidence is limited and inconsistent; it does not permit conclusions about the benefits of ESWT for medial tibial stress syndrome. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have osteonecrosis of the femoral head who receive ESWT, the evidence includes three systematic reviews of small, mostly nonrandomized studies. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. While many of the studies have suggested that ESWT might be effective in improving motor function and reducing pain, particularly in patients with early-stage osteonecrosis, the studies were judged of low quality based on lack of blinding, lack of comparators, small sample sizes, short follow-up, and variations in treatment protocols. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have nonunion or delayed union who receive ESWT, the evidence includes a systematic review of an RCT and several case series, as well as 2 RCTs published after the systematic review. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. Reviewers concluded that the evidence was inconsistent and of poor quality. Data pooling was not possible due to the heterogeneity of outcome definitions and treatment protocols. The evidence is insufficient to determine the effects of the technology on health outcomes.

For individuals who have spasticity who receive ESWT, the evidence includes RCTs and systematic reviews. Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. As a treatment for spasticity, several small studies have demonstrated ESWT provides short-term improvements in Modified Ashworth Scale scores, but direct evidence on the effect of ESWT on more clinically meaningful measures (e.g., pain, 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 about the evidence base. The evidence is insufficient to determine the effects of the technology on health outcomes.

Practice Guidelines and Position Statements

American College of Foot and Ankle Surgeons

Thomas et al (2010) revised guidelines on the treatment of heel pain on behalf of the American College of Foot and Ankle Surgeons.80 The guidelines identified extracorporeal shock wave therapy (ESWT) as a third tier treatment modality in patients who have failed other interventions, including steroid injection. The guidelines recommended ESWT as a reasonable alternative to surgery. In an update to the American College of Food and Ankle Surgeons clinical consensus statment, Schneider et al (2018) stat that ESWT is a safe and effective treatment for plantar fasciitis.

National Institute for Health and Care Excellence

The National Institute for Health and Care Excellence has published guidance on ESWT for a number of applications.

  • A guidance issued in 2003 stated that current evidence on safety and efficacy for treatment of calcific tendonitis of the shoulder “appears adequate to support the use of the procedure.”
  • The 2 guidance documents issued in 2009 stated that current evidence on the efficacy of ESWT for refractory tennis elbow and plantar fasciitis “is inconsistent.”
  • A guidance issued in 2011 stated that evidence on the efficacy and safety of ESWT for refractory greater trochanteric pain syndrome “is limited in quality and quantity.”
  • A guidance issued in 2016 stated that current evidence on the efficacy of ESWT for Achilles tendinopathy “is inconsistent and limited in quality and quantity.”

Canadian Agency for Drugs and Technologies in Health

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. The report noted that the “lack of convergent findings from randomized trials of ESWT for chronic plantar fasciitis suggests uncertainty about its effectiveness. The evidence reviewed … does not support the use of this technology for this condition.”

Similarly, a 2007 report by CADTH on ESWT for chronic lateral epicondylitis noted conflicting results from randomized trials (RCTs), with half showing no benefit over placebo for any outcome measures. The report noted 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 CADTH concluded 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.”

A 2016 update from CADTH addressed the use of shockwave therapy for pain associated with upper- extremity orthopedic disorders. Based on results from 7 systematic reviews (with overlapping randomized controlled trials), the Agency concluded the following (see Table 4).

Table 4. Conclusions on the Use of ESWT for Upper-Extremity Pain

Condition

Evidence

Comparator

Conclusions

Shoulder

Calcific tendonitis

Systematic reviews

Placebo

Effective in reducing pain

Noncalcific tendonitis

Systematic reviews

Placebo or other treatments

No significant benefit

Tendonitis

Single RCTs

Exercise or radiotherapy

No significant benefit

Tendonitis

1 RCT

Transcutaneous electric nerve stimulation

Effective in reducing pain

Elbow

Lateral epicondylitis

Systematic reviews

Placebo

Inconclusive

Lateral epicondylitis

Single RCTs

Physical therapy or percutaneous tenotomy

No significant benefit

Lateral epicondylitis

Single RCTs

Corticosteroid injections

Inconclusive

ESWT: extracorporeal shockwave treatment; RCT: randomized controlled trial.

U.S. Preventive Services Task Force Recommendations

Not applicable.

Key Words:

Extracorporeal Shock Wave, Extracorporeal Shock Wave Therapy, Extracorporeal Shock Wave Treatment, ESW, ESWT, OssaTron, Orthospec™ Orbasone™, SONOCOR, Epos™ Ultra,  Extracorporeal pulse activation therapy, EPAT, D-Actor 100

Approved by Governing Bodies:

Currently, 6 focused ESWT devices have been approved by FDA through the premarket approval process for orthopedic use (see Table 5).

Table 5. FDA-Approved Extracorporeal Shock Wave Therapy Devices

Device Name

Approval Date

Delivery System Type

Indication

OssaTron® device (HealthTronics)

2000

Electrohydraulic delivery system

  • Chronic proximal plantar fasciitis, ie, pain persisting >6 mo and unresponsive to conservative management
  • Lateral epicondylitis

Epos™ Ultra (Dornier)

2002

Electromagnetic delivery system

Plantar fasciitis

Sonocur® Basic (Siemens)

2002

Electromagnetic delivery system

Chronic lateral epicondylitis (unresponsive to conservative therapy for >6 mo)

Orthospec™ Orthopedic ESWT (Medispec)

2005

Electrohydraulic spark-gap system

Chronic proximal plantar fasciitis in patients ≥18 y

Orbasone™ Pain Relief System (Orthometrix)

2005

High-energy sonic wave system

Chronic proximal plantar fasciitis in patients ≥18 y

Duolith® SD1 Shock Wave Therapy Device (Storz Medical AG)

2016

Electromagnetic delivery system

Chronic proximal plantar fasciitis in patients ≥18 y with history of failed alternative conservative therapies >6 mo

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 one week to one 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.

In 2007, Dolorclast® (EMS Electro Medical Systems), a radial ESWT, was approved by FDA through the premarket approval process. Radial ESWT is generated ballistically by accelerating a bullet to hit an applicator, which transforms the kinetic energy into radially expanding shock waves. 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. The FDA-approved indication is for the treatment of patients 18 years and older with chronic proximal plantar fasciitis and a history of unsuccessful conservative therapy.

Benefit Application:

Coverage is subject to member’s specific benefits.  Group specific policy will supersede this policy when applicable.

ITS: Home Policy provisions apply

FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity.

Current Coding:

CPT Codes:

28890              Extracorporeal shock wave, high energy, performed by a physician, requiring anesthesia other than local, including ultrasound guidance, involving the plantar fascia

0101T             Extracorporeal shock wave involving musculoskeletal system, not otherwise specified, high energy

0102T             Extracorporeal shock wave, high energy, performed by a physician requiring anesthesia other than local, involving lateral humeral epicondyle

Previous Coding:

CPT Codes:

0019T             Extracorporeal shockwave, involving musculoskeletal system, not otherwise specified; low energy (Deleted 12/31/16)

References:

  1. Al-Abbad H, Simon JV. The effectiveness of extracorporeal shock wave therapy on chronic achilles tendinopathy: a systematic review. Foot Ankle Int. Jan 2013; 34(1):33-41.
  2. Alessio-Mazzola M, Repetto I, Biti B, et al. Autologous US-guided PRP injection versus US-guided focal extracorporeal shock wave therapy for chronic lateral epicondylitis: A minimum of 2-year follow-up retrospective comparative study. J Orthop Surg (Hong Kong). Jan-Apr 2018; 26(1):2309499017749986.
  3. Alvarez R.  Preliminary results on the safety and efficacy of the OssaTron for treatment of plantar fasciitis.  Foot & Ankle International 2002; 23(3): 197-203.
  4. Alves EM, Angrisani AT, Santiago MB. The use of extracorporeal shock waves in the treatment of osteonecrosis of the femoral head: a systematic review. Clin Rheumatol. Nov 2009; 28(11):1247-1251.
  5. Aqil A, Siddiqui MR, Solan M et al. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: a meta-analysis of RCTs. Clin Orthop Relat Res. Nov 2013; 471(11):3645-3652.
  6. Arirachakaran A, Boonard M, Yamaphai S, et al. Extracorporeal shock wave therapy, ultrasound-guided percutaneous lavage, corticosteroid injection and combined treatment for the treatment of rotator cuff calcific tendinopathy: a network meta-analysis of RCTs. Eur J Orthop Surg Traumatol. Apr 2017; 27(3):381-390.
  7. Bannuru RR, Flavin NE, Vaysbrot E, et al. High-energy extracorporeal shock-wave therapy for treating chronic calcific tendinitis of the shoulder: a systematic review. Ann Intern Med. Apr 15 2014; 160(8):542-549.
  8. Barnes M. Letter to the editor. "Low-energy extracorporeal shock wave therapy as a treatment for medial tibial stress syndrome". Am J Sports Med. Nov 2010; 38(11):NP1; author reply NP1-2.
  9. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Extracorporeal shockwave treatment for musculoskeletal indications. TEC Assessments 2001; Volume 16, Tab 20.
  10. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Extracorporeal shock wave treatment for musculoskeletal indications TEC Assessments 2003; Volume 18, Tab 5.
  11. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Extracorporeal shock wave treatment for chronic plantar fasciitis. TEC Assessments 2004; Volume 19, Tab 18.
  12. Blue Cross and Blue Shield Association Technology Evaluation Center (TEC). Extracorporeal shock wave treatment for chronic tendonitis of the elbow TEC Assessments 2004; Volume 19, Tab 16.
  13. Buchbinder R, et al.  Systematic review of the efficacy and safety of shock wave therapy for lateral elbow pain.  Journal Rheumatology 2006; 33(7):1351-1363.
  14. Buchbinder R, Green S, Youd J et al. Shock wave therapy for lateral elbow pain. Cochrane Database Syst Rev 2005; 4:CD003524.
  15. Buchbinder R., Ptasznik R.,  et al.  Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial.  JAMA 2002; 288(11): 1365-1372.
  16. Cacchio A, Giordano L, Colafarina O et al. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. Nov 2009; 91(11):2589-2597.
  17. Canadian Agency for Drugs and Technologies in Health (CADTH). Shockwave Therapy for Pain Associated with Upper Extremity Orthopedic Disorders: A Review of the Clinical and Cost-Effectiveness. Rapid Response Report; 2016; www.cadth.ca/sites/default/files/pdf/htis/2016/RC0808-ShockwaveTx-Final.pdf.
  18. Capan N, Esmaeilzadeh S, Oral A, et al. Radial extracorporeal shock wave therapy is not more effective than placebo in the management of lateral epicondylitis: a double-blind, randomized, placebo-controlled trial. Am J Phys Med Rehabil. Nov 5 2015.
  19. Carlisi E, Lisi C, Dall'angelo A, et al. Focused extracorporeal shock wave therapy combined with supervised eccentric training for supraspinatus calcific tendinopathy. Eur J Phys Rehabil Med. Nov 08 2016.
  20. Chen HS, Chen LM, and Huang TW. Treatment of painful heel syndrome with shock waves. Clin Ortho and Related Research 2001; 387: 41-46.
  21. Chen JM, Hsu SL, Wong T et al. Functional outcomes of bilateral hip necrosis: total hip arthroplasty versus extracorporeal shockwave. Arch Orthop Trauma Surg. Jun 2009; 129(6):837-841.
  22. Chung B, et al. Effectiveness of extracorporeal shock wave therapy in the treatment of previously untreated lateral epicondylitis: a randomized controlled trial. Amer. Journal Sports Medicine 2004; 32(7): 1660-1667.
  23. Cinar E, Saxena S, Uygur F. Combination therapy versus exercise and orthotic support in the management of pain in plantar fasciitis: a randomized controlled trial. Foot Ankle Int. Apr 2018; 39(4):406-414.
  24. Cole Charles Seto Craig and Gazewood John. Plantar fasciitis: Evidence-based review of diagnosis and therapy. American Family Physician, December 2005, Vol. 72, No. 11.
  25. Costa ML, Shepstone L, Donell ST et al. Shock wave therapy for chronic Achilles tendon pain: a randomized placebo-controlled trial. Clin Orthop Relat Res. Nov 2005; 440:199-204.
  26. Daliri SS, Forogh B, Emami Razavi SZ, et al. A single blind, clinical trial to investigate the effects of a single session extracorporeal shock wave therapy on wrist flexor spasticity after stroke. NeuroRehabilitation. Dec 29 2015; 36(1):67-72.
  27. Dingemanse R, Randsdorp M, Koes BW, et al. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. Jun 2014; 48(12):957-965.
  28. Dizon JN, Gonzalez-Suarez C, Zamora MT et al. Effectiveness of extracorporeal shock wave therapy in chronic plantar fasciitis: a meta-analysis. Am J Phys Med Rehabil. Jul 2013; 92(7):606-620.
  29. Dornier Medical Systems Inc. Dornier Epos™ Ultra summary of safety and effectiveness, PMA #P000048.
  30. Dorotoka R, Sabeti M, et al. Location modalities for focused extracorporeal shock wave application in the treatment of chronic plantar fasciitis. Foot Andle Int 2006; 27(11): 943-947.
  31. Engebretsen K, et al. Supervised exercises compared with radial extracorporeal shock-wave therapy for subacromial shoulder pain: 1-year results of a single-blind randomized controlled trial. Phys Ther 2011; 91(1):37-47.
  32. Eslamian F, Shakouri SK, Jahanjoo F, et al. Extra corporeal shock wave therapy versus local corticosteroid injection in the treatment of chronic plantar fasciitis, a single blinded randomized clinical trial. Pain Med. Sep 2016; 17(9):1722-1731.
  33. Eslamian F, Shakouri SK, Jahanjoo F, et al. Extra corporeal shock wave therapy versus   local corticosteroid injection in the treatment of chronic plantar fasciitis, a single blinded randomized clinical trial. Pain Med. Sep 2016; 17(9):1722-1731.
  34. Furia JP, Rompe JD, Maffulli N, et al. Radial extracorporeal shock wave therapy is effective and safe in chronic distal biceps tendinopathy. Clin J Sport Med. Sep 2017; 27(5):430-437.
  35. Gerdesmeyer L, Frey C, Vester J et al. Radial extracorporeal shock wave therapy is safe and effective in the treatment of chronic recalcitrant plantar fasciitis: results of a confirmatory randomized placebo-controlled multicenter study. Am J Sports Med. Nov 2008; 36(11):2100-2109.
  36. Gerdesmeyer L, Wagenpfeil S, Haake, M, et al. Extracorporeal shock wave therapy for treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial.  JAMA. 2003; 290(19): 2573-2580.
  37. Gollwitzer H, Diehl P, von Korff A et al. Extracorporeal shock wave therapy for chronic painful heel syndrome: a prospective, double blind, randomized trial assessing the efficacy of a new electromagnetic shock wave device. J Foot Ankle Surg. Sep-Oct 2007; 46(5):348-357.
  38. Gollwitzer H, Saxena A, DiDomenico LA, et al. Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study. J Bone Joint Surg Am. May 6 2015; 97(9):701-708.
  39. Greve JM, Grecco MV, Santos-Silva PR. Comparison of radial shockwaves and conventional physiotherapy for treating plantar fasciitis. Clinics (Sao Paulo) 2009; 64(2):97-103.
  40. Gunduz R, Malas FU, Borman P et al. Physical therapy, corticosteroid injection, and extracorporeal shock wave treatment in lateral epicondylitis. Clinical and ultrasonographical comparison. Clin Rheumatol. May 2012; 31(5):807-812.
  41. Haake M, Buch M, Schoellner C et al. Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. BMJ 2003; 327(7406):75-80.
  42. Haake M, Konig IR, Decker T et al. Extracorporeal shock wave therapy for lateral epicondylitis: a randomized multicenter trial. J Bone Joint Surg Am. Nov 2002; 84-A (11):1982-1991.
  43. Hammer DS, Rupp S, Ensslin S et al. Extracorporal shock wave therapy in patients with tennis elbow and painful heel. Arch Orthop Trauma Surg 2000; 120: 304-307.
  44. Han Y, Lee JK, Lee BY, et al. Effectiveness of lower energy density extracorporeal shock wave therapy in the early stage of avascular necrosis of the femoral head. Ann Rehabil Med. Oct 2016; 40(5):871-877.
  45. Hao Y, Guo H, Xu Z, et al. Meta-analysis of the potential role of extracorporeal shockwave therapy in osteonecrosis of the femoral head. J Orthop Surg Res. 2018 Jul 3;13(1):166.
  46. HealthTronics Surgical Services Inc. Supplementary data including: Final report G960232 for HealthTronics OssaTron™ indicated for ESWL treatment of Chronic Proximal Plantar Fasciitis, submitted to FDA on April 6, 2001.
  47. Helbig K, Herbert C, Schostok T et al. Correlations between the duration of pain and the success of shock wave therapy. Clin Ortho and Related Research 2001; 387: 68-71.
  48. Ho C. Extracorporeal shock wave treatment for chronic lateral epicondylitis (tennis elbow). Issues Emerg Health Technol 2007; (96 (part 2)):1-4.
  49. Ho C. Extracorporeal shock wave treatment for chronic plantar fasciitis (heel pain). Issues Emerg Health Technol 2007; (96 (part 1)):1-4.
  50. Ho C. Extracorporeal shock wave treatment for chronic rotator cuff tendonitis (shoulder pain). Issues Emerg Health Technol 2007; (96 (part 3)):1-4.
  51. Hrobjartsson A Gotzche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001; 344: 1504-1602.
  52. Hsu CJ, Wang DY, Tseng KF et al. Extracorporeal shock wave therapy for calcifying tendinitis of the shoulder. Shoulder Elbow Surg. Jan-Feb 2008; 17(1):55-59.
  53. Huisstede BM, Gebremariam L, van der Sande R et al. Evidence for effectiveness of Extracorporal Shock-Wave Therapy (ESWT) to treat calcific and non-calcific rotator cuff tendinosis--a systematic review. Man Ther. Oct 2011; 16(5):419-433.
  54. Ibrahim MI, Donatelli RA, Hellman M, et al. Long-term results of radial extracorporeal shock wave treatment for chronic plantar fasciopathy: A prospective, randomized, placebo-controlled trial with two years follow-up. J Orthop Res. Jul 2017; 35(7):1532-1538.
  55. Ibrahim MI, et al. Chronic plantar fasciitis treated with two sessions of radial extracorporeal shock wave therapy. Foot & Ankle International. May 2010; 31(5): 391-397.
  56. Ioppolo F, Tattoli M, Di Sante L et al. Clinical improvement and resorption of calcifications in calcific tendinitis of the shoulder after shock wave therapy at 6 months' follow-up: a systematic review and meta-analysis. Arch Phys Med Rehabil. Sep 2013; 94(9):1699-706.
  57. Jeon JH, Jung YJ, Lee JY et al. The effect of extracorporeal shock wave therapy on myofascial pain syndrome. Ann Rehabil Med. Oct 2012; 36(5):665-674.
  58. Jung YJ, Park WY, Jeon JH, et al. Outcomes of ultrasound-guided extracorporeal shock wave therapy for painful stump neuroma. Ann Rehabil Med. Aug 2014; 38(4):523-533.
  59. Kaptchuk TJ, Goldman P, Stone DA, Stason WB. Do medical devices have enhanced placebo effects?  J of Clinical Epidemiology 2000; 53: 786-792.
  60. Kim EK, Kwak KI. Effect of extracorporeal shock wave therapy on the shoulder joint functional status of patients with calcific tendinitis. J Phys Ther Sci. Sep 2016; 28(9):2522-2524.
  61. Kim YS, Lee HJ, Kim YV, et al. Which method is more effective in treatment of calcific tendinitis in the shoulder? Prospective randomized comparison between ultrasound-guided needling and extracorporeal shock wave therapy. J Shoulder Elbow Surg. Nov 2014; 23(11):1640-1646.
  62. Kudo P, et al. Randomized, placebo-controlled, double-blind clinical trial evaluating the treatment of plantar fasciitis with an extracorporeal shockwave therapy (ESWT) device: a North American confirmatory study. Journal Orthopedic Res. 2006; 24(2):115-123.
  63. Kvalvaag E, Brox JI, Engebretsen KB, et al. Effectiveness of radial extracorporeal shock wave therapy (rESWT) when combined with supervised exercises in patients with subacromial shoulder pain: a double-masked, randomized, sham-controlled trial. Am J Sports Med. Sep 2017; 45(11):2547-2554.
  64. Kvalvaag E, Roe C, Engebretsen KB, et al. One year results of a randomized controlled trial on radial Extracorporeal Shock Wave Treatment, with predictors of pain, disability and return to work in patients with subacromial pain syndrome. Eur J Phys Rehabil Med. Jun 27 2017.
  65.  Lai TW, Ma HL, Lee MS, et al. Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: A randomized controlled trial. J Musculoskelet Neuronal Interact. Mar 1 2018; 18(1):47-54.
  66. Lebrun CM. Low-dose extracorporeal shock wave therapy for previously untreated lateral epicondylitis. Clinical Journal Sports Medicine 2005; 15(5):401-402.
  67. Lee JY, Kim SN, Lee IS, et al. Effects of Extracorporeal Shock Wave Therapy on Spasticity in Patients after Brain Injury: A Meta-analysis. J Phys Ther Sci. Oct 2014; 26(10):1641-1647.
  68. Lee JY, Yoon K, Yi Y, et al. Long-term outcome and factors affecting prognosis of extracorporeal shockwave therapy for chronic refractory Achilles tendinopathy. Ann Rehabil Med. Feb 2017; 41(1):42-50.
  69. Li S, Wang K, Sun H, et al. Clinical effects of extracorporeal shock-wave therapy and ultrasound-guided local corticosteroid injections for plantar fasciitis in adults: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 Dec;97(50):e13687.
  70. Liao CD, Xie GM, Tsauo JY, et al. Efficacy of extracorporeal shock wave therapy for knee tendinopathies and other soft tissue disorders: a meta-analysis of randomized controlled trials. BMC Musculoskelet Disord. 2018 Aug 2;19(1):278.
  71. Liu S, Zhai L, Shi Z et al. Radial extracorporeal pressure pulse therapy for the primary long bicipital tenosynovitis a prospective randomized controlled study. Ultrasound Med Biol. May 2012; 38(5):727- 735.
  72. Lizis P. Analgesic effect of extracorporeal shock wave therapy versus ultrasound therapy in chronic tennis elbow. J Phys Ther Sci. Aug 2015; 27(8):2563-2567.
  73. Lohrer H, et al. Comparison of radial versus focused extracorporeal shock waves in plantar fasciitis using functional measures. Foot & Ankle International. January 2010; 31(1):1-9.
  74. Lou J, Wang S, Liu S, et al. Effectiveness of extracorporeal shock wave therapy without local anesthesia in patients with recalcitrant plantar fasciitis: a meta-analysis of randomized controlled trials. Am J Phys Med Rehabil. Dec 09 2016.
  75. Lynen N, De Vroey T, Spiegel I, et al. Comparison of peritendinous hyaluronan injections versus extracorporeal shock wave therapy in the treatment of painful Achilles' tendinopathy: a randomized clinical efficacy and safety study. Arch Phys Med Rehabil. Jan 2017; 98(1):64-71.
  76. Malay DS.  Extracorporeal shockwave therapy versus placebo for the treatment of chronic proximal plantar fasciitis: results of a randomized, placebo-controlled, double-blinded, multicenter intervention trial. Journal Foot & Ankle Surgery 2006; 45(4):196-210.
  77. Mani-Babu S, Morrissey D, Waugh C, et al. The Effectiveness of Extracorporeal Shock Wave Therapy in Lower Limb Tendinopathy: A Systematic Review. Am J Sports Med. May 9 2014.
  78. Marwan Y, Husain W, Alhajii W, et al. Extracorporeal shock wave therapy relieved pain in patients with coccydynia: a report of two cases. Spine J. Jan 2014; 14(1):e1-4.
  79. Metzner G, et al. High-energy extracorporeal shock-wave therapy (ESWT) for the treatment of chronic plantar fasciitis.  Foot & Ankle International Sept 2010; 31(9):790-796.
  80. Moerman DE, Jones WB.  Deconstructing the placebo effect and finding the meaning response.  Ann Intern Med 2002; 136: 471-476.
  81. Moghtaderi A, Khosrawi S, Dehghan F. Extracorporeal shock wave therapy of gastroc-soleus trigger points in patients with plantar fasciitis: A randomized, placebo-controlled trial. Adv Biomed Res. 2014; 3:99.
  82. National Institute for Health and Clinical Excellence (NICE). Extracorporeal shockwave therapy for refractory tennis elbow: guidance. 2009. www.nice.org.uk/nicemedia/live/12124/45249/45249.pdf.
  83. National Institute for Health and Clinical Excellence (NICE). Extracorporeal shockwave therapy for refractory Achilles tendonopathy: guidance. 2009. www.nice.org.uk/nicemedia/live/12123/45245/45245.pdf.
  84. National Institute for Health and Clinical Excellence (NICE). Extracorporeal shockwave therapy for refractory greater trochanteric pain syndrome. 2011. www.nice.org.uk/nicemedia/live/12975/52604/52604.pdf.
  85. National Institute of Health and Clinical Excellence (NICE). Extracorporeal shockwave lithotripsy for calcific tendonitis (tendonopathy) of the shoulder: guidance. 2003. Available online at: www.nice.org.uk/nicemedia/live/11093/30992/30992.pdf.
  86. National Institute of Health and Clinical Excellence (NICE). Extracorporeal shockwave therapy for refractory plantar fasciitis: guidance. 2009. www.nice.org.uk/nicemedia/live/11187/45188/45188.pdf.
  87. Newman P, Waddington G, Adams R. Shockwave treatment for medial tibial stress syndrome: A randomized double blind sham-controlled pilot trial. J Sci Med Sport. Mar 2017; 20(3):220-224.
  88. Notarnicola A, Quagliarella L, Sasanelli N, et al. Effects of extracorporeal shock wave therapy on functional and strength recovery of handgrip in patients affected by epicondylitis. Ultrasound Med Biol. Dec 2014; 40(12):2830-2840.
  89. Ogden J. Shock wave therapy for chronic proximal plantar fasciitis: a meta-analysis. Foot & Ankle International 2002; 23(4): 301-308.
  90. Ogden J.A., Alvarez R., Levitt R. et al. Shock wave therapy for chronic proximal plantar fasciitis. Clin Orthop 2001; 387: 47-59.
  91. Ogden JA, Alvarez RG, Levitt R and Marlow M. Shock wave therapy (Orthotripsy®) in musculoskeletal disorders. Clin Ortho and Related Research 2001; 387: 22-40.
  92. Ogden JA. Alvarez RG, Levitt RL. Et al. Electrohydraulic high-energy shock-wave treatment for chronic plantar fasciitis. J Bone Joint Surg Am 2004; 86-A (10):2216-2228.
  93. Park JW, Yoon K, Chun KS, et al. Long-term outcome of low-energy extracorporeal shock wave therapy for plantar fasciitis: comparative analysis according to ultrasonographic findings. Ann Rehabil Med. Aug 2014; 38(4):534-540.
  94. Pettrone FA, McCall BR. Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis. J Bone Joint Surg Am. Jun 2005; 87(6):1297-1304.
  95. Radwan YA, ElSobhi G, Badawy WS et al. Resistant tennis elbow: shock-wave therapy versus percutaneous tenotomy. Int Orthop 2008; 32(5):671-677.
  96. Radwan YA, Mansour AM, Badawy WS. Resistant plantar fasciopathy: shock wave versus endoscopic plantar fascial release. Int Orthop. Oct 2012; 36(10):2147-2156.
  97. Rasmussen S, Christensen M, Mathiesen I et al. Shockwave therapy for chronic Achilles tendinopathy: a double-blind, randomized clinical trial of efficacy. Acta Orthop. Apr 2008; 79(2):249-256.
  98. Rompe JD, Cacchio A, Furia JP et al. Low-energy extracorporeal shock wave therapy as a treatment for medial tibial stress syndrome. Am J Sports Med. Jan 2010; 38(1):125-132.
  99. Rompe JD, Decking J, Schoellner C et al. Repetitive low-energy shock wave treatment for chronic lateral epicondylitis in tennis players. Am J Sports Med. Apr-May 2004; 32(3):734-743.
  100. Rompe JD, Decking J, Schoellner C, Nafe B. Shock wave application for chronic plantar fasciitis in running athletes: A prospective, randomized, placebo-controlled trial. Am J Sport Med 2003; 31(2): 268-275.
  101. Rompe JD, Furia J, Weil L, et al. Shock wave therapy for chronic plantar fasciopathy. Br. Med. Bull. April 2007; 81-82:183-208.
  102. Rompe JD, Schoellner C, Nafe B. Evaluation of low-energy extracorporeal shock-wave application for treatment of chronic plantar fasciitis. J Bone Joint Surg 2002; 84-A(3): 335-341.
  103. Santamato A, Micello MF, Panza F, et al. Extracorporeal shock wave therapy for the treatment of poststroke plantar-flexor muscles spasticity: a prospective open-label study. Top Stroke Rehabil. 2014; 21 Suppl 1:S17-24.
  104. Santamato A, Panza F, Notarnicola A, et al. Is extracorporeal shockwave therapy combined with isokinetic exercise more effective than extracorporeal shockwave therapy alone for subacromial impingement syndrome? a randomized clinical trial. J Orthop Sports Phys Ther. Sep 2016; 46(9):714-725.
  105. Schneider HP, Baca JM, Carpenter BB, et al. American College of Foot and Ankle Surgeons Clinical Consensus Statement : Diagnosis and Treatment of Adult Acquired Infracalcaneal Heel Pain. J Foot Ankle Surg. Mar-Apr 2018 ;57(2) ;370-381.
  106. Schofer MD, Hinrichs F, Peterlein CD et al. High-versus low-energy extracorporeal shock wave therapy of rotator cuff tendinopathy; a prospective, randomized, controlled study. Acta Orthop Beig. Aug 2009; 75(4):452-458. 
  107. Smith J, Sellon JL. Comparing PRP injections with ESWT for athletes with chronic patellar tendinopathy. Clin J Sport Med. Jan 2014; 24(1):88-89.
  108. Staples MP, Forbes A, Ptasznik R et al. A randomized controlled trial of extracorporeal shock wave therapy for lateral epicondylitis (tennis elbow). J Rheumatol. Oct 2008; 35(10):2038-2046.
  109. Sun J, Gao F, Wang Y, et al. Extracorporeal shock wave therapy is effective in treating chronic plantar fasciitis: A meta-analysis of RCTs. Medicine (Baltimore). Apr 2017; 96(15):e6621.
  110. Theodore GH, Buch M, Amendola, A, et al. Extracorporeal shock wave therapy for the treatment of plantar fasciitis. Foot and Ankle International. 2004; 25(5): 290-297.
  111. Thijs KM, Zwerver J, Backx FJ, et al. Effectiveness of shockwave treatment combined with eccentric training for patellar tendinopathy: a double-blinded randomized study. Clin J Sport Med. Mar 2017; 27(2):89-96.
  112. Thomas JL, Christensen JC, Kravitz SR et al. The diagnosis and treatment of heel pain: a clinical practice guideline-revision 2010. J Foot Ankle Surg. May-Jun 2010; 49(3 Suppl):S1-19.
  113. Thomson CE, Crawford F and Murray GD. The effectiveness of extra corporeal shock wave therapy for plantar heel pain: A systematic review and meta-analysis. BMC Musculoskelet Disorder, April 2005; 6: 19.
  114. Trompetto C, Avanzino L, Bove M et al. External shock waves therapy in dystonia:  preliminary results. Eur J Neurol 2009; 16(4):517-521.
  115. U.S. Food and Drug Administration. Orbasone summary of safety and effectiveness. 2005; www.accessdata.fda.gov/cdrh_docs/pdf4/P040039b.pdf.
  116. U.S. Food and Drug Administration. Orthospec summary of safety and effectiveness data. 2005; www.accessdata.fda.gov/cdrh_docs/pdf4/P040026b.pdf.
  117. U.S. Food and Drug Administration. OssaTron summary of safety and effectiveness. 2000; www.accessdata.fda.gov/cdrh_docs/pdf/P990086b.pdf.
  118. U.S. Food and Drug Administration. SONOCUR summary of safety and effectiveness. 2002; www.accessdata.fda.gov/cdrh_docs/pdf/P010039b.pdf.
  119. van Leeuwen MT, Zwerver J, van den Akker-Scheek I. Extracorporeal shockwave therapy for patellar tendinopathy; a review of the literature. Br J Sports Med. Mar 2009; 43(3):163- 168.
  120. Verstraelen FU, In den Kleef NJ, Jansen L, et al. High-energy versus low-energy extracorporeal shock wave therapy for calcifying tendinitis of the shoulder: which is superior? A meta-analysis. Clin Orthop Relat Res. Sep 2014; 472(9):2816-2825.
  121. Vidal X, Morral A, Costa L et al. Radial extracorporeal shock wave therapy (rESWT) in the treatment of spasticity in cerebral palsy: a randomized, placebo-controlled clinical trial. NeuroRehabilitation. Jan 1 2011; 29(4):413-419.
  122. Wang CJ, Chen HS, Chen WS, Chen LM. Treatment of painful heels using extracorporeal shock wave. J Formos Med Assoc 2000: 99: 580-583.
  123. Wang CJ, Liu HC, Fu TH. The effects of extracorporeal shockwave on acute high-energy long bone fractures of the lower extremity. Arch Orthop Trauma Surg. Feb 2007; 127(2):137-142.
  124. Wang CJ, Wang FS, Yang KD, Weng LH, Ko JY. Long-term Results of Extracorporeal Shockwave Treatment for Plantar Fasciitis. Am J Sports Med 2006; 34(4): 592-596.
  125. Weil LS, Roukis TS, et al. Extracorporeal shock wave therapy for the treatment of chronic plantar fasciitis: indications, protocol, intermediate results, and a comparison of results to fasciotomy. J of Foot & Ankle Surgery 2002; 41(3): 166-172.
  126. Williams H, Jones SA, Lyons C, et al. Refractory patella tendinopathy with failed conservative treatment-shock wave or arthroscopy? J Orthop Surg (Hong Kong). Jan 2017; 25(1):2309499016684700.
  127. Wu YC, Tsai WC, Tu YK, et al. Comparative effectiveness of non-operative treatments for chronic calcific tendinitis of the shoulder: A systematic review and network meta-analysis of randomized-controlled trials. Arch Phys Med Rehabil. Apr 08 2017.
  128. Wu Z, Yao W, Chen S, et al. Outcome of extracorporeal shock wave therapy for insertional Achilles tendinopathy with and without Haglund's deformity. Biomed Res Int. Nov 2016;2016:6315846.
  129. Yang TH, Huang YC, Lau YC, et al. Efficacy of radial extracorporeal shock wave therapy on lateral epicondylosis, and changes in the common extensor tendon stiffness with pretherapy and posttherapy in real-time sonoelastography: a randomized controlled study. Am J Phys Med Rehabil. Feb 2017; 96(2):93-100.
  130. Yin MC, Ye J, Yao M, et al. Is extracorporeal shock wave therapy clinical efficacy for relief of chronic, recalcitrant plantar fasciitis? A systematic review and meta-analysis of randomized placebo or active-treatment controlled trials. Arch Phys Med Rehabil. Aug 2014; 95(8):1585-1593.
  131. Yu H, Cote P, Shearer HM, et al. Effectiveness of passive physical modalities for shoulder pain: systematic review by the Ontario protocol for traffic injury management collaboration. Phys Ther. Mar 2015; 95(3):306-318.
  132. Zelle BA, Gollwitzer H, Zlowodzki M et al. Extracorporeal shock wave therapy: current evidence. J Orthop Trauma. Mar 2010; 24 Suppl 1:S66-70.
  133. Zhai L, Ma XL, Jiang C, et al. Human autologous mesenchymal stem cells with extracorporeal shock wave therapy for nonunion of long bones. Indian J Orthop. Sep 2016; 50(5):543-550.
  134. Zhang Q, Liu L, Sun W, et al. Extracorporeal shockwave therapy in osteonecrosis of femoral head: A systematic review of now available clinical evidences. Medicine (Baltimore). Jan 2017; 96(4):e5897.
  135. Zhiyun L, Tao J, Zengwu S. Meta-analysis of high-energy extracorporeal shock wave therapy in recalcitrant plantar fasciitis. Swiss Med Wkly. 2013; 143:w13825.
  136. Zimmermann R, Cupanas A, Hoeltl L et al. Extracorporeal shock-wave therapy for treating chronic pelvic pain syndrome: a feasibility study and the first clinical results. BJUI 2008; 102:976-980.

Policy History:

Medical Review Committee, February 2001

Medical Policy Group, December 2001

Medical Policy Group, October 2002

Medical Policy Committee, October 2002

Medical Policy Administration Committee, November 2002

Available for Comments, November 19, 2002-January 3, 2003

Medical Policy Group, August 2004 (2)

Available for comments September 2-October 16, 2004

Medical Policy Group, December 2006 (1)

Medical Policy Group, July 2007 (1)

Medical Policy Group, December 2008 (2)

Medical Policy Administration Committee, January 2009

Available for comment January 9-February 23, 2009

Medical Policy Group, March 2010 (2)

Medical Policy Group, January 2011

Medical Policy Group, February 2011 (5): Key Points & References

Medical Policy Group, March 2011 (1): Key Points & References

Medical Policy Group, February 2012 (4): Updated Key Points and References

Medical Policy Panel, February 2013

Medical Policy Group, February 2013 (2): 2013 Updates to Description, Key Points and References; no change in policy statement (clarified musculoskeletal conditions)

Medical Policy Panel, February 2014

Medical Policy Group, February 2014 (1): Update to Key Points and References; no change to policy statement

Medical Policy Panel, February 2015

Medical Policy Group, February 2015 (2): Updates to Description, Key Points, Approved by Governing Bodies, and References, updated policy statement to include “using either a high- or low- dose protocol or radial ESWT” and added Achilles tendinitis, patellar tendinitis, and spasticity to musculoskeletal conditions; no change to intent.

Medical Policy Panel, July 2016

Medical Policy Group, July 2016 (7): Updates to Key Points, Approved by Governing Bodies, and References.  No change to policy statement.

Medical Policy Group, December 2016: 2017 Annual Coding Update. Created Previous Coding section and moved deleted CPT code 0019T to this section.

Medical Policy Panel, June 2017

Medical Policy Group, July 2017 (7): Updates to Description, Key Points, Approved by Governing Bodies, and References. No change to policy statement.

Medical Policy Panel, June 2018

Medical Policy Group, August 2018 (7): Updates to Description, Key Points, and References. No change to policy statement.

Medical Policy Panel, July 2019

Medicl Policy Group, July 2019 (7): Updates to Description, Key Points, and References. No change to Policy Statement.

This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.

The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.

As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.

The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:

1. The technology must have final approval from the appropriate government regulatory bodies;

2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;

3. The technology must improve the net health outcome;

4. The technology must be as beneficial as any established alternatives;

5. The improvement must be attainable outside the investigational setting.

Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:

1. In accordance with generally accepted standards of medical practice; and

2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and

3. Not primarily for the convenience of the patient, physician or other health care provider; and

4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.