BlueCross and BlueShield of Montana Medical Policy/Codes
Extracorporeal Shock Wave Treatment for Musculoskeletal Indications and Soft Tissue Injuries
Chapter: Medicine: Treatments
Current Effective Date: August 27, 2013
Original Effective Date: May 17, 2002
Publish Date: August 27, 2013
Revised Dates: March 1, 2005; April 6, 2012; July 25, 2013
Description

Extracorporeal shockwave treatment (ESWT), also known as orthotripsy, has been available since the early 1980s for the treatment of renal stones and has been widely investigated for the treatment of biliary stones.  Shock waves create a transient pressure disturbance, which disrupts solid structures, breaking them into smaller fragments, thus allowing spontaneous passage and/or removal of stones.  The mechanism by which ESWT might have an effect on musculoskeletal conditions is not well defined.  Chronic musculoskeletal conditions, such as tendinitis, can be associated with a substantial degree of scarring and calcium deposition.  Calcium deposits may restrict motion and encroach on other structures such as nerves and blood vessels, causing pain and decreased function.  One hypothesis is that disruption of these calcific deposits by shock waves may loosen adjacent structures and promote resorption of calcium, thereby decreasing pain and improving function.

Other functions are also thought to be involved.  Physical stimuli are known to activate endogenous pain control systems and activation by shock waves may “reset” the endogenous pain receptors.  Damage to endothelial tissue from ESWT may result in increased vessel wall permeability, causing increased diffusion of cytokines, which may in turn promote healing.  Microtrauma induced by ESWT may promote angiogenesis and thus aid in healing.  Finally, shock waves have been shown to stimulate osteogenesis and promote callous formation in animals, which is the rationale for trials of ESWT in delayed union or non-union of bone fractures.

Currently, five ESWT devices are approved for marketing by the U.S. Food and Drug Administration (FDA).  The OssaTron® device (HealthTronics, Marietta, GA), an electrohydraulic delivery system was approved by the FDA on July 20, 2000, for patients with chronic proximal plantar fasciitis (i.e., pain persisting more than six months and not responding to conservative management).  It is also FDA approved for treatment of lateral epicondylitis (tennis elbow).  The Epos™ Ultra (Dornier, Germering, Germany), an electromagnetic delivery system, was approved by the FDA on January 15, 2002, for plantar fasciitis.  The SONOCUR® Basic (Seimans, Erlangen, Germany) also uses an electromagnetic delivery system and was approved by the FDA for use in chronic lateral epicondylitis (symptoms unresponsive to conservative therapy for more than six months) on July 19, 2002.  In 2005, the Orthospec™ Orthopedic ESWT (Medispec Ltd, Germantown, MD), an electrohydraulic spark-gap device, and the Orbasone™ Pain Relief System (Orthometrix, White Plains, NY), a high-energy sonic wave system, received approval for treatment of chronic proximal plantar fasciitis in patients 18 years of age or older.

Both high-dose and low-dose protocols have been investigated.  A high-dose protocol consists of a single treatment of high energy shock waves (1300mJ/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.

Another type of ESWT, radial ESWT (rESWT) received FDA pre-market approval (PMA) in May 2007.  The FDA-approved device is the Doloclast (spelled Dolorclast in the PMA summary) from EMS Electro Medical Systems, Nyon, Switzerland. Radial ESWT is generated ballistically by accelerating a bullet to hit an applicator, which transforms the kinetic energy into radially expanding shock waves.  Other types of ESWT produce focused shock waves that show deeper tissue penetration with significantly higher energies concentrated to a small focus.  Radial ESWT is described as an alternative to focused ESWT and is said to address larger treatment areas, thus providing potential advantages in superficial applications like tendinopathies.

Pulsed Acoustic Cellular Expression (PACE) is a new ESWT modality utilizing the dermaPACE® device.  This device delivers high-energy acoustic pressure waves in the shock wave spectrum to produce compressive and tensile stresses on cells and tissue structures to promote angiogenic and positive inflammatory responses, and quickly initiate the healing cascade.  The PACE treatment modality is said to result in revascularization and microcirculatory improvement, including the production of angiogenic growth factors, enhanced new blood vessel formation (angiogenesis), and the subsequent regeneration of tissue such as skin, musculoskeletal and vascular structures.

Policy

Each benefit plan, summary plan description or contract defines which services are covered, which services are excluded, and which services are subject to dollar caps or other limitations, conditions or exclusions.  Members and their providers have the responsibility for consulting the member's benefit plan, summary plan description or contract to determine if there are any exclusions or other benefit limitations applicable to this service or supply.  If there is a discrepancy between a Medical Policy and a member's benefit plan, summary plan description or contract, the benefit plan, summary plan description or contract will govern.

Investigational

Blue Cross and Blue Shield of Montana (BCBSMT) considers extracorporeal shock wave treatment (ESWT), using either a low or high dose protocol or radial ESWT (rESWT), experimental, investigational and unproven for all musculoskeletal indications and soft tissue injuries including but not limited to:

  • Plantar fasciitis (with or without a heel spur);or
  • Other diseases of the tendon including but not limited to calcific tendinitis of the shoulder, tendonitis of the elbow (epicondylitis, tennis elbow); or
  • Stress fracture, or
  • Delayed union and nonunion; or
  • Avascular necrosis of the hip, or
  • Wound healing.

Rationale

The most clinically relevant outcome measures of ESWT are pain and functional limitations. Pain is a subjective, patient-reported measure.  Therefore, pain outcomes require quantifiable pre- and post-treatment measures.  Pain is most commonly measured with a visual analog scale (VAS).  Quantifiable pre- and post-treatment measures of functional status are also used, such as SF-12 and SF-36.  Minor adverse effects of ESWT are common but transient, including local pain, discomfort, local trauma, bleeding, and swelling.  More serious adverse outcomes of ESWT may potentially include neurologic damage causing numbness or tingling, permanent vascular damage, or rupture of a tendon or other soft tissue structure.

In 2001, the Blue Cross Blue Shield Association Technology Evaluation Center (TEC) issued an Assessment that concluded ESWT met the TEC criteria as a treatment for plantar fasciitis in patients who had not responded to conservative therapies.  Therefore, the 2001 Blue Cross Blue Shield Association medical policy stated that ESWT would be considered medically necessary in these patients.  A 2003 TEC Assessment reviewed subsequently available literature on ESWT for musculoskeletal conditions with a focus on three conditions: plantar fasciitis, tendonitis of the shoulder, and tendonitis of the elbow.  The 2003 TEC Assessment came to different conclusions, specifically, that ESWT did not meet the TEC criteria as a treatment of plantar fasciitis or other musculoskeletal conditions.  Therefore, the policy statement was revised to indicate that ESWT is investigational.  In October 2004, updated TEC Assessments were completed for plantar fasciitis and tendinitis of the elbow.  The 2004 TEC Assessments concluded that ESWT did not meet TEC criteria for the treatment of plantar fasciitis or tendonitis of the elbow.

Plantar Fasciitis

The October 2004 TEC Assessment on extracorporeal shock wave treatment for plantar fasciitis  agreed with the 2003 Assessment and concluded that the evidence is not sufficient to permit conclusions on the health outcome effects of ESWT for chronic plantar fasciitis.  Eight studies met the inclusion criteria for the 2004 BCA TEC Assessment.  Five double-blind, randomized clinical trials reporting on 992 patients were considered to be of high quality and are summarized below.

  • HealthTronics Surgical Services, Inc. - This trial randomized 293 patients to a single treatment of high-dose ESWT or sham ESWT.  A composite measure incorporating four discrete outcome measures of patient assessment of pain, investigator assessment of pain, patient assessment of activity, and use of pain medications was used.  Both sham and active treatment groups improved at 12 weeks post-treatment.  Two outcomes (investigator assessment of pain and patient assessment of pain) met statistical significance.  Patient assessment of activity and pain medication use were similar in both groups, and differences were not statistically significant.
  • Buchbinder et al. - This trial enrolled 166 patients.  Three treatment sessions of ESWT were given at weekly intervals.  Patients were randomized to either ESWT or sham ESWT treatments.  Study measures included overall, morning, and activity pain measured on VAS scale, the Maryland Foot Score, and quality of life using SF36.  Improvements of a similar magnitude were reported for both groups on measures of pain and functioning.  There were no significant group differences on any of the outcome measures.
  • Haake et al. - This trial randomized 272 patients to three treatments every two weeks of medium-energy ESWT or sham ESWT.  Successful treatment was defined as a Roles and Maudsley score of one or two and no additional treatment.  Secondary outcomes were the Roles and Maudsley score; patient self-rating of pain at rest, at night, at pressure, and in the morning along a VAS scale from 0 to 10; walking ability; additional treatment; and side effects.  Although both groups improved at 12 and 52 weeks, the difference between groups was not statistically significant.
  • Rompe et al. - This trial randomized 45 patients (who ran 30 or more miles per week) to three treatments at weekly intervals of either medium-energy or sham ESWT.  Treatment success was defined as 50% improvement in self-assessment of morning pain.  Additional outcomes were the American Orthopaedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot scale and a modification of the Roles and Maudsley score.  At six months’ follow-up, the ESWT group had greater improvement on self-assessment of morning pain (p<0.001), the AOFAS Ankle-Hindfoot scale (p<0.001), and the Roles and Maudsley scale (p=0.01) compared to the placebo group; treatment success was 60% for the ESWT group and 27% for the placebo group (p=0.06).
  • Dornier Medical Systems, Inc. - This trial randomized 150 patients to receive one treatment with high-dose ESWT or sham ESWT.  Outcomes were measured after three months.  Study measures included VAS rating of morning pain, pain during the day, physical activity pain, and night pain.  Additional measures were the Roles and Maudsley score, the SF-12, the AOFAS Ankle-Hindfoot score, and pain on palpation.  The ESWT group had greater improvement in the average rating of morning pain (3.4 vs. 4.1, p=0.04) and greater percentage of patients scoring excellent/good on the Roles and Maudsley score (62% vs. 40%, p=0.03).  Group differences on the remaining outcomes were nonsignificant, and post-treatment scores were not reported.

Overall, evidence included in the 2004 TEC Assessment showed a statistically significant effect between-group difference in morning pain measured on a 0–10 VAS score.  The clinical significance of the change is uncertain.  The absolute value and effect size are small.  The most complete information on the number needed to treat (NNT) to achieve 50%–60% reduction in morning pain is from two studies of high-energy ESWT (and including confidential data provided by Dornier), combined NNT = 7 (95% CI: 4–15).   Improvements in pain measures are not clearly associated with improvements in function.  Effect size for improvement in pain with activity was non-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 significant difference in quality-of-life measurement (SF-12, physical and mental scales) or use in pain medication.

Subsequently, Ogden et al. reported additional follow-up from the 12-week result included in the 2004 TEC Assessment.  However, after 12 weeks, randomization was not preserved, making conclusions from the follow-up problematic.

In addition, results have been reported to the FDA from trials delivering ESWT with the Orthospec™, Orthopedic ESWT, and Orbasone™ Pain Relief System.

  • Orthospec™ -- Efficacy was examined in a multicenter, double-blind, sham-controlled trial randomizing 172 participants with chronic proximal plantar fasciitis failing conservative therapy to ESWT or sham treatments in a two to one ratio.  At three months, the ESWT arm had less investigator-assessed pain with application of a pressure sensor (0.94 points lower on a ten-point VAS, 95% CI: 0.02 to 1.87).  However, there was no difference in improvement in patient-assessed activity and function between ESWT and sham groups.
  • Orbasone™ -- In a multicenter, randomized, sham-controlled, double-blind trial, 179 participants with chronic proximal plantar fasciitis were randomized to active or sham treatment.  At three months, both active and sham groups improved in patient-assessed pain on awakening (by 4.6 and 2.3 points respectively on a 10-point VAS; crude difference between groups at three months of 2.3, 95% CI: 1.5 to 3.3).  While ESWT was associated with more rapid improvement (and statistically significant) in a mixed-effects regression model, insufficient details were provided to evaluate the analyses.

While approved by the FDA for treatment of chronic plantar fasciitis and examined for efficacy in apparently well-designed, randomized, double-blind, controlled trials, the weight of evidence remains consistent with the conclusions of the 2004 TEC Assessment.  Definitive, clinically meaningful treatment benefits at three months were not apparent nor was it evident that the longer-term disease natural history was altered.  Finally, a recent meta-analysis conducted by Thomson et al. included results from six randomized, controlled trials (897 participants).  For the endpoint of morning pain assessed using a VAS, they concluded that although statistically significant, the effect size was very small.  Furthermore, excluding the two poorest quality trials from the meta-analysis resulted in a statistically insignificant effect.

Tendinitis of the Elbow

Six randomized, double-blinded, placebo-controlled trials enrolling 808 patients with lateral epicondylitis met the inclusion criteria for the 2004 TEC Assessment.  Four trials were rated “good” quality and are summarized below.

SONOCUR trial -- In this trial, 114 patients were randomized to low-energy ESWT or sham ESWT for three treatment sessions administered in one week intervals.  The main outcome measures were percent response on self-reported pain scale (at least 50% improvement on 0–100 VAS) and change in the Upper Extremity Function Scale (UEFS).  Results of the two main outcome measures at three months showed greater improvement in the ESWT group.  Response rate was 60% in the active treatment group and 29% in the placebo group (p<0.001).  There was a 51% improvement in the UEFS score for the active treatment group, compared with a 30% improvement in the placebo group (p<0.05).

  • OssaTron. -- This trial randomized 183 patients to a single session of high-energy or sham ESWT. Treatment success was a 50% improvement on investigator and self-assessment of pain on a 0–10 VAS and no or rare use of pain medication.  At the eight-week follow-up, the ESWT group had a greater rate of treatment success than the placebo group (35% vs. 22%, p <0.05).  Mainly responsible for group differences in treatment success was the investigator assessment of pain (48% vs. 29%, p <0.01); the improvements in self-assessment of pain (81% vs. 70%, p =0.06) and non-use of pain medication (81% vs. 70%, p =0.09) were only marginal.
  • Haake et al. -- This trial randomized 272 patients to three sessions of low-energy or sham ESWT.  Treatment success was defined as achieving a Roles and Maudsley score of one or two with no 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 three did not differ between groups at either 12 weeks (31.7% ESWT vs. 33.1% placebo) or at one year (65.7% ESWT vs. 65.3% placebo) of follow-up.  Furthermore, the groups did not differ along any of five pain assessment measures or on grip strength.
  • Rompe et al -- This trial randomized 78 tennis players to three treatments at week intervals of low-energy or sham ESWT.  Outcomes included pain ratings during wrist extension and the Thomsen Provocation Test, the Roles and Maudsley score, the Upper Extremity Function score, grip strength, and satisfaction with return to activities.  At three months’ follow-up, the ESWT group, compared to placebo, significantly improved on all outcomes except grip strength.  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 to 35% of the placebo group were satisfied with their return to activities (p=0.01).

Since the 2004 TEC Assessment, Pettrone and McCall reported results from a randomized double-blind trial conducted in three large orthopedic practices for 114 patients receiving either ESWT in a "focused" manner (2,000 impulses at 0.06 mJ/mm-two without local anesthesia) weekly for three weeks or placebo.  Randomization was maintained through 12 weeks, and benefit demonstrated with respect to a number of outcomes: pain, functional scale, and activity score.  Pain assessed on the VAS (scaled here to 10 points) declined at 12 weeks in the treated group from 7.4 to 3.8 (mean 3.6, 95% CI: 2.8 to 4.5); among placebo patients from 7.6 to 5.1 (mean 2.4, 95% CI: 1.6 to 3.3).  A reduction in Thomsen test pain of at least 50% was demonstrated in 60.7% of those treated compared to 29.3% in the placebo group (ARR 31.4%, 95% CI: 13.2 to 46.9).  Mean improvement on a 10-point upper extremity functional activity score was 2.4 for ESWT-treated patients compared to 1.4 in the placebo group—difference at 12 weeks of 0.9 (95% CI .18 to 1.6).

This study found benefit of ESWT for lateral epicondylitis over 12 weeks.  However, the placebo group also improved significantly; whether the natural history of disease was altered is unclear. In the context of mixed results from previous studies, only exceedingly convincing differential outcomes would provide sufficient evidence to alter the conclusions of the 2004 TEC Assessment.  Further, a recent Cochrane review, which included the Pettrone and McCall trial, concluded “there is ‘Platinum’ level evidence [the strongest level of evidence] that shock wave therapy provides little or no benefit in terms of pain and function in lateral elbow pain.”

Current evidence does not support the use of ESWT to treat lateral epicondylitis.

Other Indications

Costa et al. conducted a randomized, double-blind, placebo-controlled trial of ESWT for chronic Achilles tendon pain treated monthly for three months.  The study randomized 49 participants and was powered to detect a 50% reduction in VAS pain scores.  No difference in pain relief at rest or during sport participation was found at one year.  Two older ESWT-treated participants experienced tendon ruptures.

Other possible uses of ESWT noted in the literature but not supported by evidence include: stress fracture, delayed union and non-union of bone fractures, avascular necrosis of the femoral head, osteochondritis dissecans, patellar tendinitis, and other forms of chronic tendinitis.  Specifically, a literature search identified no controlled clinical trials for any of these indications.

A search of Medline was completed for the last two years through April 17, 2007.  No new scientific data was found that would change the coverage position of this policy.

2009 Update

Investigators continue to arrive at contradictory conclusions regarding the efficacy of ESWT for musculoskeletal conditions.  Differences in treatment parameters among studies including energy dosage, method of generating and directing shock waves, and use or absence of anesthesia preclude making generalizations from results of multiple studies.  The precise mechanism of action of ESWT and the impact of anesthesia on outcomes continue to be matters of discussion.

Heel Pain

Three randomized controlled trials published since the last review were identified.  Gerdesmeyer et al. report on a multicenter double-blind randomized controlled trial (RCT) of radial ESWT (rESWT) conducted for FDA PMA of the Doloclast (spelled Dolorclast in the PMA summary) from EMS Electro Medical Systems.  In this study, 252 patients were randomized, 129 to rESWT and 122 to sham treatment.  The patients had heel pain for at least six months and failure of at least two nonpharmacological and two pharmacological treatments prior to entry into the study.  Three treatments at weekly intervals were planned, and more than 90% of patients in each group had all three treatments. One patient required local anesthesia, which was allowed by the study protocol.  Outcome measures were composite heel pain (pain on first steps of the day, with activity and as measured with Dolormeter), change in individual visual analogue scale (VAS) scores, and Roles and Maudsley score measured at twelve weeks and twelve months.  (The PMA summary indicates that VAS scores were adjusted if rescue pain medications or other treatments were used by adding two points to the VAS score at the affected visit.  This was not noted in the published article; no further details on the use of analgesics were provided in the publication.)  Success was defined as at least 60% improvement in two of three VAS scores OR, if less pain reduction, then patient had to be able to work and complete activities of daily living, had to be satisfied with the outcome of the treatment, and must not have required any other treatment to control heel pain.   Patients who did not achieve success at the 12-week follow-up were allowed to withdraw and their results were carried forward for the 12-month analysis.  (For this reason, results at 12 months are not discussed in this section.)  A value of P<0.025 (1-sided) for between group difference was considered significant.  A number of secondary outcomes were also measured at 12 weeks, including changes in Roles and Maudsley score, SF-36 physical percent changes, SF-36 mental percent changes, investigator’s judgment of effectiveness, patient’s judgment of therapy satisfaction, and patient recommendation of therapy to a friend.  At the12 week follow-up rESWT was followed by a decrease of the composite VAS score of heel pain by 72.1% vs. 44.7% after placebo (P=.0220); although the final VAS scores were not provided.  Success rates on individual VAS scores were as follows: heel pain when taking first steps in the morning, 60.8% for ESWT vs. 48.31% for placebo (P=0.0269 – not significant), heel pain during daily activities, 60% for ESWT vs. 40.68% (P=0.0014), and heel pain after application of Dolormeter, 52.85% vs. 39.66% (P=.0216).  The success rate for the composite score was 61% vs. 42% (P=0.002).  Statistically significant differences were noted on all secondary measures.  On SF-36 physical, the percent change was -44.1 for ESWT and -23.9 for placebo and on SF-36 mental the change was -22.8 vs. -14.3.  Just over half (58.4%) of the ESWT group and 41.52% of placebo group had good or excellent Roles and Maudsley scores.  Patient global judgment of therapy satisfaction was very or moderately satisfied in 63.16% of ESWT and 46.36% of placebo patients.  There are a number of limitations concerning this published study that prevent definite conclusions from being reached, including the following: the limited data concerning specific outcomes (e.g., presenting percent changes rather than actual results of measures); inadequate description of prior treatment (or intensity of treatment) provided before referral to the study; use of the composite outcome measure; and no data on the use of rescue medication.  In addition, the clinical significance of changes (and relative changes) in outcome measures is uncertain from this publication.  There are also questions about the adequacy of patient blinding regarding treatment. 

In a smaller single-center double-blind trial in Germany 40 patients were randomized to receive either focused ESWT provided by the Duolith® SD1 device or sham treatment.  (The Duolith SD1, from Storz Medical, is a small, mobile shockwave device that provides either electromagnetic focused ESWT or radial pressure wave.  It does not have FDA approval.) Anesthesia was not used.  Outcome measures were the same as described by Gerdesmeyer et al.  In this study, active ESWT resulted in a 73% reduction in composite heel pain at the 12-week follow-up, a 33% greater reduction than achieved by sham treatment.  Between-group differences in reductions in composite and individual VAS scores were not statistically significant.  Marks et al. describe a small (25-subject) double-blind RCT of low energy ESWT for plantar fasciitis. Outcome measures were pain on VAS, and Roles and Maudsley scores before ESWT, early after treatment, and six months later.  They report that there appeared to be a significant placebo effect with ESWT and a lack of evidence of efficacy compared to sham treatment.

Achilles Tendinopathy

Rasmussen et al. reported a single-center double-blind controlled trial with 48 patients, half of them randomized after four weeks of conservative treatment to four sessions of active radial ESWT and half to sham ESWT.  Primary endpoint was the American Orthopaedic Foot and Ankle Society (AOFAS) score measuring function, pain, and alignment and pain on VAS.  The AOFAS score after treatment increased from 70 (SD 6.8) to 88 (SD 10) in the ESWT group and from 74 (SD 12) to 81 (SD 16) in the control (p=0.05).  Pain was reduced in both groups with no statistically significant difference between groups.  The authors note that the AOFAS score may not be appropriate for the evaluation of treatment of Achilles tendinopathy.  They conclude that ESWT appears to be a clinically relevant supplement to conservative treatment of tendinopathy, however there is no convincing evidence for recommendation of the treatment.

Epicondylitis

Staples and colleagues conducted a double-blind controlled trial of ultrasound-guided ESWT for epicondylitis.  Sixty-eight patients were randomized to receive three ESWT treatments or three treatments at a subtherapeutic dose at weekly intervals.  There were significant improvements in most of the seven outcome measures for both groups over six months of follow-up and no between-group differences.  The authors found little evidence to support use of ESWT for this indication.  Radwan et al randomly assigned 56 patients with persistent tennis elbow to ESWT without anesthesia (29 patients) or percutaneous tenotomy (27 patients).  Both groups improved at all time points through 12 months of follow-up.  At three months, the success rates, defined as Roles and Maudsley score of excellent and good, were 74.1% of patients in the tenotomy group and 65.5% of ESWT patients.

Shoulder Pain

A summary by the Canadian Agency for Drugs and Technologies in Health concludes that ”the current evidence supports the use of high-energy ESWT for chronic calcific rotator cuff tendonitis that is recalcitrant to conventional conservative treatment, although more high-quality RCTs with larger sample sizes are required to provide more convincing evidence.”   Hsu and colleagues conclude from their single-center RTC that ESWT shows promise for treatment of calcifying tendonitis of the shoulder.  They randomized 33 patients to receive two courses of ESWT and 13 patients to sham treatment and measured radiographic outcomes, Constant score and pain scale.  ESWT results were good to excellent in 87.9% of shoulders and fair in 12.1%.  In the controls, 69.2% had fair and 30.1% poor results.  Calcium deposits were completely eliminated in seven and partially eliminated in 11 of ESWT patients and partially eliminated in two control patients.

Patellar Tendinopathy

A literature review to study the effectiveness of ESWT for patellar tendinopathy and to draft a treatment protocol resulted in review of seven articles.  The authors found that most studies had methodological deficiencies, small numbers and/or short follow-up periods, and treatment parameters varied among studies.  They concluded that ESWT appears to be safe and promising treatment, but that a treatment protocol cannot be recommended and further basic and clinical research is required.

Summary

A search of peer-reviewed literature through October 2009 identified some studies, including a multicenter study of radial-ESWT.  These studies continue to provide weak or contradictory evidence of efficacy of ESWT for all musculoskeletal conditions.  Therefore, the coverage position of this medical policy is unchanged.

2011 Update

A search of peer reviewed literature was conducted through November 2011.  Following is a summary of the key literature from this update.

Plantar Fasciitis

Given current data, the search focused on newly published RCTs.  In 2010, Ibrahim and colleagues published a small trial (n=50) comparing ESWT to sham treatment.  Eligible patients had unilateral plantar fasciitis for more than six months despite conservative therapy.  Patients were randomized to receive two sessions of rESWT via the Dolorclast™ device or two sham treatments utilizing the same device but with an intervening clasp to prevent transmission of the shock waves.  Primary endpoint of pain was measured at baseline and at 4, 12, and 24 weeks by a blinded investigator utilizing the ten-point VAS and the four-point RM functional pain scale.  The treatment group had a significant decline in mean pain score at all follow-up visits.  The VAS scores were reduced from 8.5 to 0.6 at four weeks (-92.5%), 1.1 at 12 weeks (-87.3%), and 0.5 at 24 weeks (-93.9%).  RM scores showed similar declines.  The sham group also experienced a decline in pain scores but to a lesser degree.  The range of reported declines in this group ranged between 6% and 17% for both pain measures.  Between group differences were significant at each visit.  Treatment success was further defined as a 60% decline in VAS from baseline at 24 weeks; this was achieved in 100% (25/25) of ESWT-treated patients, but only 16% (4/25) of placebo-treated patients (p< 0.001).  The principal investigator was not blinded to the intervention.  The study attempted to control for this by having a standardized protocol for interacting with the patient during the procedure, but inadvertent signaling could have occurred. Also, no anesthesia was used, and patients may have sensed the active intervention, or lack thereof.

In 2009, Greve and colleagues published the results of a small RCT (n=32) comparing radial shock wave therapy to physical therapy.  In this study, patients were not blinded.  Of note, 23 patients (72%) had not undergone any previous treatment, in contrast to previous studies in which chronic plantar fasciitis patients were enrolled only after failing conservative therapy.  Group one was treated with ten ultrasound treatments and physical therapy, group two received three weekly sessions of rESWT.  Both groups received education on home stretching exercises. Multiple outcomes were measured.  All pain measures improved in both groups after treatment and at three-month follow-up; however, no significant differences were noted between groups.  Given the small sample size and entry criteria, no conclusions can be drawn from thus study.

Also in 2010, Thomas and colleagues published a revised practice guideline on the treatment of heel pain on behalf of the American College of Foot and Ankle Surgeons (ACFAS).  This guideline identifies ESWT as a third tier treatment modality in patients who have failed other interventions, including steroid injection.  The guideline recommends ESWT as a reasonable alternative to surgery.

Tendinopathy

No additional systematic reviews or RCTs were identified addressing the use of ESWT in Achilles, elbow shoulder, or patellar tendonitis in this update.  In 2009, Rompe and colleagues published a report on the use of ESWT in medial tibial stress syndrome (MTSS), commonly known as “shin splints”.  In this non-randomized cohort study, 47 patients with MTSS for at least six months received three weekly sessions of rESWT, and were compared to 47 age-matched controls at four months.  Mild adverse events were noted in ten patients: skin reddening in two patients and pain during the procedure in eight patients.  Patients rated their condition on a six-point Likert scale.  Successful treatment was defined as self-rating “completely recovered” or “much improved”.  The authors report a significant success rate of 64% (30/47) in the treatment group compared to 30% (14/47) in the control group.  This study represents another potential use for ESWT.  In a letter to the editor, Barnes et al. have raised several limitations of this study.  In a nonrandomized study, the possibility of selection bias is introduced.  This is particularly problematic when outcomes are patient-reported.  Larger, randomized trials are needed.

Osteonecrosis of the Femoral Head

A systematic review of ESWT in osteonecrosis (avascular necrosis) of the femoral head was conducted by Alves and colleagues in 2009.  Only five articles, all from non-US sites, were identified: two RCTs, one comparative study, one open-label study, and one case report for a total of 133 patients.  Several studies were from one center in Taiwan.  Of the two RCTs, one (n=48) was randomized to the use of concomitant alendronate; ESWT treatments were in both arms of the study and ESWT was therefore not the comparator.  The other RCT compared ESWT to a standard surgical procedure.  All results noted a reduction in pain over the time of the study, which was attributed by each study’s authors to a positive effect of ESWT.  However, the authors of this review noted the limitations of the available evidence: lack of double-blind design, small numbers of patients included, short duration of follow-up and non-standard intervention, e.g., energy level and number of treatments.  The authors’ state that more research is needed, particularly well-designed RCTs, to further elucidate the role of ESWT in treatment of osteonecrosis of the femoral head.

A comparative study not included in the Alves et al. systematic review was published by Chen and colleagues in 2009.  In this small study, for each of 17 patients with bilateral hip osteonecrosis one side was treated with total hip arthroplasty, while the other was treated with ESWT.  Each patient was evaluated at baseline and after treatment utilizing VAS for pain and Harris hip score, a composite measure of pain and hip function.  There was a significant reduction in scores before and after treatment in both treatment groups.  Hips treated with ESWT were also evaluated for radiographic reduction of bone marrow edema on magnetic resonance imaging (MRI), which also appeared to be reduced.  The authors then compared the ESWT-treated data to the total hip arthroplasty results, stating that the magnitude of improvement was greater for the ESWT-treated hips.  However, hips were not randomized to treatment intervention; the side with the greater degree of disease was treated with surgery in each case. Moreover, time between hip interventions within the same patient averaged 17.3 months, with a range of 6 to 36 months; in all but one case, surgery preceded ESWT.  Therefore, conclusions about the superiority of one intervention over the other cannot be made.  Based on the systematic review and this study, the impact of ESWT on net health outcome for osteonecrosis is unknown.

Nonunion, Delayed Union, Acute Fractures

One RCT was identified comparing ESWT to surgery for nonunion of long-bone fractures.  Cacchio and colleagues enrolled 126 patients into three groups: low- or high- energy ESWT therapy, or surgery.  Patients were identified for participation in the study if referred to one of three Italian centers with nonunion fractures, here defined as at least six months without evidence of radiographic healing.  The primary endpoint was radiographic evidence of healing.  Secondary endpoint data of pain and functional status were collected by blinded evaluators.  Neither patients nor treating physicians were blinded.  At six months, rates in the lower energy ESWT, higher energy ESWT, and surgical arms had similar healing rates (70%, 71%, and 73%, respectively).  There was no significant difference among the groups at this stage.  All groups’ healing rates improved at further follow-up at 12 and 24 months without significant between-group differences.  Secondary endpoints of pain and disability were also examined and were similar.  The authors believe this to be the first RCT of its kind and encourage additional study.  Lack of blinding may have led to differing levels of participation in other aspects of the treatment protocol. 

In 2010, Zelle and colleagues reviewed the English and German medical literature for studies of ESWT in the treatment of fractures and delayed union/nonunion, restricted to studies with greater than ten patients.  Ten case series and one RCT were identified.  Number of treatment sessions, energy protocols, and definitions of nonunion varied across studies; union rate after intervention was likewise heterogeneous, ranging from 40.7% to 87.5%.  The authors conclude the overall quality of evidence is conflicting and of poor quality.

The RCT included in the Zelle review reported on the use of ESWT in acute long bone fractures. Wang and colleagues randomized trauma patients (n=56) with femur or tibia fractures to a single ESWT treatment following surgical fixation while still under anesthesia.  Patients in the control group underwent surgical fixation but did not receive the ESWT treatment.  Patients were evaluated for pain and percent of weight-bearing capability on the affected leg by an independent, blinded evaluator.  Radiographs taken at these same intervals were evaluated by a radiologist blinded to study group for fracture healing or nonunion.  Both groups showed significant improvement in pain scores and weight-bearing status.  Between-group comparisons of pain by VAS and weight bearing favored study patients at each interval.  At six months, patients who had received ESWT had VAS scores of 1.19 compared to 2.47 in the control group (p<0.001); mean percentage of weight bearing at six months was 87% versus 78%, respectively (p=0.01).  Radiographic evidence of union at each interval also favored the study group.  At six months, 63% (17/27) of the study group achieved fracture union compared to 20% (6/30) in the control group (p<0.001).  The authors note some limitations to the study: the small number of patients in the study, surgeries performed by multiple surgeons and questions regarding adequacy of randomization.

Wound Healing

Schaden et al. (2007) evaluated the feasibility and safety of ESWT for acute and chronic soft-tissue wounds.  A total of 208 patients with complicated, non-healing, acute and chronic soft tissue wounds were prospectively enrolled onto this trial.  Treatment consisted of debridement, out-patient ESWT [100 to 1000 shocks/cm(2) at 0.1 mJ/mm(2), according to wound size, every one to two weeks over a mean of three treatments], and moist dressings.  Thirty-two (15.4 %) patients dropped out of the study following first ESWT and were analyzed on an intent-to-treat basis as incomplete healing.  Of 208 patients enrolled 156 (75 %) had 100 % wound epithelialization.  During mean follow-up period of 44 days, there was no treatment-related toxicity, infection, or deterioration of any ESWT-treated wound.  Intent-to-treat multi-variate analysis identified age (p = 0.01), wound size less than or equal to 10 cm(2) (p = 0.01; OR = 0.36; 95 % CI: 0.16 to 0.80), and duration less than or equal to one month (p < 0.001; OR = 0.25; 95 % CI: 0.11 to 0.55) as independent predictors of complete healing.  The authors concluded that the ESWT strategy is feasible and well-tolerated by patients with acute and chronic soft tissue wounds.  Authors also noted that ESWT is being evaluated in a phase III trial for acute traumatic wounds.

A pivotal Phase III clinical trial compared the dermaPACE™ device (Sanuwave, Inc., Alpharetta, GA) to sham control for treatment of diabetic foot ulcers.  Both groups received the standard of care according to the current literature combined with active (dermaPACE group) or inactive treatment (sham group).  A total of 206 patients were enrolled in a double blinded, parallel-group sham control, 26-week clinical trial and were randomly assigned to one of the two study groups.  Although the treatment group failed to meet its primary outcome, treatment with dermaPACE increased the proportion of diabetic foot ulcers that closed within twelve weeks by 36%, which was not a statistically significant result.  Statistical significance was achieved at twelve weeks when 45% of device-treated and 26% of sham-treated patients had ≥ 90% wound closure.  At the twelve week time point, 66% of device-treated and 47% of sham-treated patients had ≥ 70% wound closure.  Throughout the entire twelve-week period patients in the device treated group had reduced wound size compared to sham-treated patients (P = 0.0038 at week 6, P = 0.0018 at week 8, P = 0.0007 at week 10, and P = 0.0041 at week 12).  At the 12-week time point, the average percent reduction in the target ulcer in patients treated with dermaPACE was 56% compared to only 7% in the patients randomized to receive sham treatment.  During the six-month follow up period, only 4.5% of the patients whose wounds closed at the twelve-week time point returned due to recurrence.  DermaPACE ™ is currently under review by the Food and Drug Administration (FDA) for premarket approval.  

Technology Assessments, Guidelines, and Position Statements

The National Institute for Clinical Excellence (NICE) has published guidance on ESWT for a number of applications.  Guidance issued in August 2009 stated that current evidence on the efficacy of ESWT for refractory tennis elbow, Achilles tendinopathy, and plantar fasciitis “is inconsistent and the procedure should only be used with special arrangements for clinical governance, consent and audit or research.”  Guidance issued in November 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, provided that normal arrangements are in place for consent, audit and clinical governance.”

Summary

ESWT has been investigated for use in a variety of conditions.  Larger double blinded prospective studies along with longer term follow-up are needed to validate the effectiveness (impact on net health outcome) of ESWT in the treatment of musculoskeletal conditions and soft tissue injuries.

Coding

Disclaimer for coding information on Medical Policies           

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy.  They may not be all-inclusive.           

The presence or absence of procedure, service, supply, device or diagnosis codes in a Medical Policy document has no relevance for determination of benefit coverage for members or reimbursement for providers.  Only the written coverage position in a medical policy should be used for such determinations.           

Benefit coverage determinations based on written Medical Policy coverage positions must include review of the member’s benefit contract or Summary Plan Description (SPD) for defined coverage vs. non-coverage, benefit exclusions, and benefit limitations such as dollar or duration caps. 

ICD-9 Codes
Experimental, investigational, and unproven for all diagnosis codes.
ICD-10 Codes
Experimental, investigational, and unproven for all diagnosis codes.
Procedural Codes: 28890, 0019T, 0101T, 0102T, 0299T, 0300T
References
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History
April 2012  Policy updated with literature search through December 2011; references 25 and 36 added and references reordered; some references removed. No change in policy statement 
August 2013 Policy formatting and language revised.  Policy statement unchanged.  Added codes 0299T and 0300T.
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Extracorporeal Shock Wave Treatment for Musculoskeletal Indications and Soft Tissue Injuries