Evidence Trace, complete trial record

In plain terms

In plain terms: Extracorporeal Shockwave Therapy (ESWT) has some human trial evidence supporting it, but the evidence is not yet strong enough for EBL to call it established. It is worth knowing about and worth discussing with your clinician.

Extracorporeal Shockwave Therapy (ESWT)

B Supported: a good trial, backed by more

Category Devices

Evidence Sham-controlled randomized trials + meta-analyses of randomized trials

Reviewed September 2026

PMIDs 25948515 · 18832341 · 23813184 · 28403111 · 12234230

The endpoint this grade is based on: self_report

The evidence as the record states it

Evidence record

PMID 25948515 PMID 18832341 PMID 23813184 PMID 28403111 PMID 12234230

Gollwitzer et al. (J Bone Joint Surg Am, 2015; PMID 25948515): 250 adults with chronic plantar fasciitis randomized, double-blind, to focused shockwave (0.25 mJ/mm2, three weekly sessions of 2,000 impulses) or placebo; heel pain fell 69.2% versus 34.5% at 12 weeks. This was the pivotal trial for FDA approval of the Storz Medical Duolith SD1 (PMA P080028). Gerdesmeyer et al. (Am J Sports Med, 2008; PMID 18832341): 245 adults randomized to radial shockwave (0.16 mJ/mm2, three sessions two weeks apart) or placebo; pain fell 72.1% versus 44.7% at 12 weeks. This was the pivotal trial for FDA approval of the EMS Swiss DolorClast, and both trials share a senior investigator (Gerdesmeyer). Aqil et al. (Clin Orthop Relat Res, 2013; PMID 23813184): meta-analysis of 7 sham-controlled trials (663 participants) favoring shockwave. Sun et al. (Medicine, 2017; PMID 28403111): meta-analysis of 9 trials (935 participants), odds ratio 2.58 for improvement, with high heterogeneity. Buchbinder et al. (JAMA, 2002; PMID 12234230): 166 adults randomized to ultrasound-guided shockwave or placebo, no benefit. Grade B: replicated benefit on self-reported pain, with one well-run null trial.

PMID 25948515 PMID 18832341 PMID 23813184 PMID 28403111 PMID 12234230

Why Grade B and not Grade A

Grade B reflects moderate human evidence -- typically a single strong trial, multiple smaller trials, or surrogate endpoint data without hard clinical outcome replication. To reach Grade A, Extracorporeal Shockwave Therapy (ESWT) would require at least one additional independent randomized trial demonstrating a hard clinical endpoint or objectively measured functional outcome in a comparable population.

What this grade covers and what it does not

Grade B for chronic plantar fasciitis. Two large sham-controlled trials and two meta-analyses of sham-controlled trials show less heel pain after three sessions given one to two weeks apart, and the benefit held at 12 weeks. Both large trials were device-maker trials run for FDA approval, which the record flags as sponsored. Self-reported pain is the endpoint, which caps the letter at B. It is not an A for two reasons as well as the endpoint: an independent sham-controlled trial published in JAMA found no benefit, and the pooled analyses report high heterogeneity, so the size of the effect varies with the device, the dose and the patient. WHAT THIS GRADE DOES NOT COVER: shoulder, elbow and other tendon conditions, erectile dysfunction and pelvic floor uses, cellulite, and general regeneration or longevity claims. None of those is graded by this letter, and clinics that own a shockwave device commonly market it for all of them. It also does not cover acute heel pain, since the trials enrolled people whose pain had lasted for months despite other care.

What would move this grade

An independent randomized trial demonstrating a hard clinical endpoint -- mortality, major adverse event, or objectively confirmed functional improvement -- in an adequately powered sample, with results independently replicated, would support Grade A.

How this was studied

Form: Focused or radial extracorporeal shockwave applied to the heel, without local anesthesia · Dose: 3 sessions of 2,000 impulses at 0.16 to 0.25 mJ/mm2, given 1 to 2 weeks apart · Population: Adults with chronic plantar fasciitis that persisted despite months of conservative care · Duration: 3 sessions over 2 to 4 weeks (weekly for focused, every two weeks for radial), with the primary outcome at 12 weeks · What is sold differs: Clinic shockwave devices are marketed for many conditions and for general regeneration. The trials support one use at a stated energy and session count; device makers often do not publish their energy settings.

How to track whether this is working Heel pain on first steps in the morning, on a 0 to 10 scale, at baseline and 12 weeks after the last session, the timepoint the trials used.