Evidence
What Does the Research Say About Shockwave Therapy?
Extracorporeal shockwave therapy has been studied in randomised trials, systematic reviews and meta-analyses across several musculoskeletal conditions. The results are supportive in places and negative in others, and this library includes both.
Direct answer
What is the overall state of the evidence?
For chronic tendon-related conditions such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinitis and gluteal tendinopathy, multiple randomised trials and pooled analyses report reduced pain with shockwave therapy compared with control or placebo. Other well-conducted trials report no difference from sham.
Device type, energy level, technique and the condition being treated all vary between studies, so results are not interchangeable — and none of this predicts an individual result.
JAMA · 2002
Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial
Buchbinder R, et al.
- Plantar Fasciitis
- Shockwave type: Not specified
A multicentre randomised controlled trial comparing shockwave therapy with sham treatment for chronic plantar fasciitis. It found no statistically significant difference between the groups on its primary pain and function outcomes.
Limitations: Findings conflict with several other trials, and the outcome measures used were later criticised as insensitive to change.
View the sourceJournal of Bone and Joint Surgery (American) · 2015
Clinically relevant effectiveness of focused extracorporeal shock wave therapy in the treatment of chronic plantar fasciitis: a randomized, controlled multicenter study
Gollwitzer H, et al.
- Plantar Fasciitis
- Shockwave type: Focused
A randomised, sham-controlled multicenter study of focused shockwave therapy in chronic plantar fasciitis that had not responded to conservative care. Patients receiving active treatment reported greater reductions in heel pain than the sham group at follow-up.
Limitations: Industry funding and involvement were disclosed, and durability of benefit well beyond the study period was not established.
View the sourceThe Journal of Foot & Ankle Surgery · 2006
Extracorporeal shockwave therapy versus placebo for the treatment of chronic proximal plantar fasciitis: results of a randomized, placebo-controlled, double-blinded, multicenter intervention trial
Malay DS, et al.
- Plantar Fasciitis
- Shockwave type: Not specified
A double-blinded, multicenter, placebo-controlled trial in chronic proximal plantar fasciitis. The active treatment group showed statistically significant improvement in heel pain versus placebo at follow-up.
Limitations: Blinding to the sensation of shockwave treatment is imperfect, and follow-up duration was limited.
View the sourcePubMed-indexed journal · 2018
Ultrasonography and clinical outcome comparison of extracorporeal shock wave therapy and corticosteroid injections for chronic plantar fasciitis: a randomized controlled trial
- Plantar Fasciitis
- Shockwave type: Not specified
This trial compared shockwave therapy with corticosteroid injection for chronic plantar fasciitis, tracking fascia thickness on ultrasound alongside pain scores. Both treatments were associated with improvement, with differences reported in the pattern and durability of relief.
Limitations: Single-centre design and short follow-up limit how far the comparison can be generalised.
View the sourceActa Orthopaedica · 2008
Shockwave therapy for chronic Achilles tendinopathy: a double-blind, randomized clinical trial of efficacy
Rasmussen S, Christensen M, Mathiesen I, Simonson O
- Achilles
- Shockwave type: Not specified
A double-blind randomised trial comparing shockwave therapy with placebo in chronic mid-portion Achilles tendinopathy, with eccentric training in both groups. The active group showed greater improvement in pain and tendon-related function scores.
Limitations: The sample was small, and because both groups exercised it is hard to isolate the shockwave-specific effect.
View the sourcePubMed-indexed journal · 2018
Effectiveness of extracorporeal shockwave therapy for chronic Achilles tendinopathy: a randomized clinical trial
- Achilles
- Shockwave type: Not specified
A double-blind randomised trial of ESWT measuring pain and AOFAS ankle-hindfoot scores in chronic Achilles tendinopathy. Improvement in pain and function was reported among patients receiving active treatment.
Limitations: With 43 patients, the trial is small and the effect estimate imprecise.
View the sourcePubMed-indexed journal · 2022
A comparison between the efficacy of eccentric exercise and extracorporeal shock wave therapy on tendon thickness, vascularity, and elasticity in Achilles tendinopathy: a randomized controlled trial
- Achilles
- Shockwave type: Not specified
This trial compared eccentric exercise with shockwave therapy in chronic mid-portion Achilles tendinopathy, tracking tendon thickness, vascularity and elasticity on imaging as well as symptoms. Both approaches showed improvement, with some imaging differences between groups.
Limitations: Imaging change did not consistently track symptom change, and the trial was moderate in size.
View the sourcePubMed-indexed journal · 2022
Treatment of jumper's knee with extracorporeal shockwave therapy: a systematic review and meta-analysis
- Knee
- Shockwave type: Mixed
A systematic review and meta-analysis pooling randomised trials of ESWT for patellar tendinopathy in athletes. Pooled results suggested a beneficial effect on pain, with certainty of evidence varying between the included studies.
Limitations: Included trials differed widely in device type, protocol and population, which weakens pooled conclusions.
View the sourceThe American Journal of Sports Medicine · 2011
No effect of extracorporeal shockwave therapy on patellar tendinopathy in jumping athletes during the competitive season
- Knee
- Shockwave type: Not specified
A randomised trial in jumping athletes treated during an active competitive season found no significant benefit of shockwave therapy over control on pain and function. It is an important counterweight to more positive trials.
Limitations: Continued heavy competitive loading may have masked any treatment effect; results may not apply outside a competitive season.
View the sourceInternational Journal of Environmental Research and Public Health · 2022
Comparative effectiveness of focused extracorporeal versus radial extracorporeal shockwave therapy for knee osteoarthritis — randomized controlled study
Ko NY, Chang CN, Cheng CH, Yu HK, et al.
- Knee
- Shockwave type: Focused vs radial
A randomised comparison of focused versus radial shockwave therapy for knee osteoarthritis pain and function. Both modalities were associated with symptomatic improvement, and the study compared their relative effectiveness.
Limitations: There was no sham arm, so treatment effect cannot be cleanly separated from natural fluctuation or placebo response.
View the sourceJAMA · 2003
Extracorporeal shock wave therapy for the treatment of chronic calcifying tendonitis of the rotator cuff: a randomized controlled trial
Gerdesmeyer L, et al.
- Shoulder
- Shockwave type: Focused
A randomised controlled trial of high-energy versus low-energy focused ESWT versus placebo for chronic calcific rotator cuff tendinitis. High-energy treatment was associated with reduced calcium deposit size and improved shoulder function versus placebo.
Limitations: Low-energy dosing showed little advantage over placebo, so results do not generalise across all device energy settings.
View the sourceArthroscopy: The Journal of Arthroscopic and Related Surgery · 2020
Comparing ultrasound-guided needling combined with a subacromial corticosteroid injection versus high-energy extracorporeal shockwave therapy for calcific tendinitis of the rotator cuff: a randomized controlled trial
- Shoulder
- Shockwave type: Focused
A randomised comparison of ultrasound-guided needling plus corticosteroid injection against high-energy focused ESWT for calcific rotator cuff tendinitis, measuring both symptoms and calcium resorption. Both produced clinical improvement, differing in the speed and pattern of resorption.
Limitations: Single-centre trial of moderate size; findings may not apply to every deposit type or location.
View the sourcePubMed-indexed journal · 2002
Extracorporeal shock wave therapy for lateral epicondylitis: a double blind randomised controlled trial
- Elbow
- Shockwave type: Not specified
A double-blind randomised trial of shockwave therapy versus sham for tennis elbow. It did not find a clear benefit of active treatment over sham on its primary outcomes.
Limitations: One of several conflicting trials in this condition; differences in dosing and technique make direct comparison difficult.
View the sourceJournal of Bone and Joint Surgery (American) · 2005
Extracorporeal shock wave therapy without local anesthesia for chronic lateral epicondylitis
- Elbow
- Shockwave type: Not specified
A randomised trial in 114 patients comparing shockwave therapy without local anaesthesia to placebo for chronic tennis elbow. The active group showed statistically significant improvement in pain and grip strength.
Limitations: The use of local anaesthesia in some earlier negative trials has been proposed as one reason results differ across the literature.
View the sourceJournal of Bone and Joint Surgery (American) · 2020
Focused shockwave treatment for greater trochanteric pain syndrome: a multicenter, randomized, controlled clinical trial
Ramon S, Russo S, Santoboni F, et al.
- Hip
- Shockwave type: Focused
A multicenter randomised trial of focused shockwave therapy for greater trochanteric pain syndrome (gluteal tendinopathy). The shockwave group showed greater improvement in hip pain and function scores at follow-up.
Limitations: Comparator conditions varied between sites and longer-term outcomes were not established.
View the sourceJBJS Reviews · 2024
Extracorporeal shockwave therapy for greater trochanteric pain syndrome
- Hip
- Shockwave type: Mixed
A review of ESWT as a non-invasive option for greater trochanteric pain syndrome, compared with exercise therapy and corticosteroid injection. It concludes the approach shows promise while noting the evidence base is still developing.
Limitations: Conclusions inherit the variability in protocols and outcome measures of the underlying trials.
View the sourceBritish Journal of Sports Medicine · 2023
Use of extracorporeal shockwave therapies for athletes and physically active individuals: a systematic review
Rhim HC, Shin J, Kang J, et al.
- Sports Medicine / Tendinopathy
- Shockwave type: Mixed
A systematic review of ESWT across musculoskeletal conditions relevant to athletes and active people, including tendinopathies and bone stress injuries. The authors found generally supportive but variable-quality evidence and discuss its role as an adjunct treatment.
Limitations: Studies varied widely in device type, dosing and outcomes, with gaps in high-quality comparative evidence for several conditions.
View the sourceBMC Sports Science, Medicine and Rehabilitation · 2024
The effect of extracorporeal shock-wave therapy on pain in patients with various tendinopathies: a systematic review and meta-analysis of randomized control trials
- Sports Medicine / Tendinopathy
- Shockwave type: Mixed
A meta-analysis pooling randomised trials of ESWT across several tendinopathy sites. Pooled results suggested a favourable overall effect on pain, with variability between tendon sites and study designs.
Limitations: Heterogeneous shockwave parameters and the risk of publication bias limit the strength of the pooled estimate.
View the sourceJournal of Clinical Orthopaedics and Trauma · 2020
Extracorporeal shock wave therapy mechanisms in musculoskeletal regenerative medicine
Silva Santos G, Santos RG, Duarte Lana JF, et al.
- Shockwave Technology
- Shockwave type: Mixed
A review of the proposed biological mechanisms by which acoustic shockwaves may influence musculoskeletal tissue, including effects on new blood vessel formation, growth factor release and pain signalling. It also discusses the physics of focused and radial devices and how they differ in penetration and energy distribution.
Limitations: Much of the mechanistic evidence comes from laboratory and animal work, so it does not directly establish clinical outcomes in people.
View the sourceJournal of Orthopaedic Research · 2011
Unfocused extracorporeal shock wave therapy as potential treatment for osteoporosis
van der Jagt OP, van der Linden JC, Schaden W, et al.
- Shockwave Technology
- Shockwave type: Unfocused
A preclinical study exploring unfocused shockwave application as a stimulus for bone formation. It is one of the sources often cited when discussing unfocused (broad-field) shockwave delivery rather than focused or radial delivery.
Limitations: This is animal-model work; it does not establish clinical outcomes in people and would require clinical trials.
View the sourceRegulatory transparency
What Is SoftWave FDA-Cleared For?
This is the section most shockwave marketing skips. FDA clearance is specific, and it is not the same thing as clearance for every condition discussed on this website.
Class I indications
- Relief of minor muscle aches and pains
- Temporary increase in local blood circulation
- Activation of connective tissue
Class II 510(k) indication
Acoustic pressure shockwaves in the treatment of chronic, full-thickness diabetic foot ulcers with wound areas no larger than 16 cm², extending through the epidermis, dermis, tendon or capsule, but without bone exposure.
Clearance for the indications above is not a claim of FDA clearance for plantar fasciitis, Achilles tendinopathy, rotator cuff tendinitis, tennis elbow, hip tendinopathy or knee osteoarthritis. Much of the peer-reviewed shockwave research in those conditions was conducted with other manufacturers' focused or radial devices. We state this plainly rather than blurring the two.
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