Extracorporeal Shock Wave Treatment for Plantar Fasciitis and Other Musculoskeletal Conditions

Policy Number: MA 2.034

Effective Date: 1/1/2026

Policy

Extracorporeal shock wave therapy (ESWT) using either a high- or low-dose protocol or radial ESWT is considered investigational as a treatment of musculoskeletal conditions, including but not limited to plantar fasciitis; tendinopathies including tendinitis of the shoulder, tendinitis of the elbow (lateral epicondylitis), Achilles tendinitis and patellar tendinitis; stress fractures; avascular necrosis of the femoral head; delayed union and non-union of fractures; and spasticity. There is insufficient evidence to support a general conclusion concerning the health outcomes or benefits associated with this procedure.

Cross-References

• MP 4.028 Wound and Burn Management and Specialized Treatment Centers

Product Variations

This policy is only applicable to certain programs and products administered by Capital Blue Cross and subject to benefit variations. Please see additional information below.

FEP PPO – Refer to FEP Medical Policy Manual.

Description/Background

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

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 1 cm or less; and
• the patient can be adequately immobilized and is of an age likely to comply with nonweight bearing.

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, coccyxdynia, 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.

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 above).

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 shock waves of single pulses lasting microseconds, directed on a specific target using fluoroscopic 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.

American College of Foot and Ankle Surgeons

In 2010, the ACFAS revised guidelines on the treatment of heel pain on behalf of the American College of Foot and Ankle Surgeons. The guidelines state that ESWT is safe and effective for treating chronic plantar fasciitis when conservative treatments have failed.

National Health Institute For Health and Care Excellence

Per the National Health Institute For Health and Care Excellence, extracorporeal shock wave therapy does not raise safety concerns, however evidence is limited for all indications.

• The evidence on extracorporeal shockwave therapy (ESWT) for refractory plantar fasciitis raises no major safety concerns; however, current evidence on its efficacy is inconsistent.
• Evidence on the safety of extracorporeal shockwave therapy for calcific tendinopathy in the shoulder shows no major safety concerns in the short term. Evidence on efficacy is inadequate.
• The evidence on extracorporeal shockwave therapy (ESWT) for Achilles tendinopathy raises no major safety concerns. Current evidence on efficacy of the procedure is inconsistent and limited in quality and quantity.
• The evidence on extracorporeal shockwave therapy (ESWT) for refractory tennis elbow raises no major safety concerns; however, current evidence on its efficacy is inconsistent.
• Evidence on the efficacy and safety of extracorporeal shockwave therapy (ESWT) for refractory greater trochanteric pain syndrome is limited in quality and quantity.

Regulatory Status

Selected ESWT devices have been approved or cleared by FDA are included in Table 2.

Table 2. FDA-Approved Extracorporeal Shock Wave Therapy Devices

FDA: Food and Drug Administration

Both high-dose and low-dose protocols have been investigated. A high-dose protocol consists of a single treatment of high-energy shock waves (1300 mJ/mm2). This painful procedure requires anesthesia. A low-dose protocol consists of multiple treatments, spaced 1 week to 1 month apart, in which lower dose shock waves are applied. This protocol does not require anesthesia. The FDA-labeled indication for the OssaTron^® and Epos™ Ultra devices 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.

Rationale

Summary of Evidence

For individuals who have plantar fasciitis who receive ESWT, the evidence includes 2 recent systematic reviews containing 9 RCTs each (8 overlapping RCTs). Relevant outcomes are symptoms, functional outcomes, quality of life, medication use, and treatment-related morbidity. While most of the same trials were included in both meta-analyses, pooled results were inconsistent. One meta-analysis reported that ESWT was beneficial in reducing pain, while the other reported nonsignificant findings in pain reduction. Reasons for the differing results include lack of uniformity in the definitions of outcomes, and heterogeneity in ESWT protocols (focused vs radial, number and duration of shocks per treatment, number of treatments). The evidence is insufficient to determine the effects of the technology on health outcomes.

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 nonoperative 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 published after the systematic review, 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 retropatella 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 2 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.

Definitions

Fasciotomy refers to a surgical incision into an area of fascia (connective tissue).

Disclaimer

Capital Blue Cross’ medical policies are used to determine coverage for specific medical technologies, procedures, equipment, and services. These medical policies do not constitute medical advice and are subject to change as required by law or applicable clinical evidence from independent treatment guidelines. Treating providers are solely responsible for medical advice and treatment of members. These polices are not a guarantee of coverage or payment. Payment of claims is subject to a determination regarding the member’s benefit program and eligibility on the date of service, and a determination that the services are medically necessary and appropriate. Final processing of a claim is based upon the terms of contract that applies to the members’ benefit program, including benefit limitations and exclusions. If a provider or a member has a question concerning this medical policy, please contact Capital Blue Cross’ Provider Services or Member Services.

Coding Information

Note: This list of codes may not be all-inclusive, and codes are subject to change at any time. The identification of a code in this section does not denote coverage as coverage is determined by the terms of member benefit information. In addition, not all covered services are eligible for separate reimbursement. The codes need to be in numerical order.

Investigational; therefore, not covered:

^*20999 is used to represent extracorporeal shock wave involving musculoskeletal system, low energy

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Policy History

• MA 2.034
• 9/16/2025 Policy creation.