Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial

Abstract

Objective To determine the effectiveness of extracorporeal shock wave therapy compared with placebo in the treatment of chronic plantar fasciitis. Design Randomised, blinded, multicentre trial with parallel group design. Setting Nine hospitals and one outpatient clinic in Germany. Participants 272 patients with chronic plantar fasciitis recalcitrant to conservative therapy for at least six months: 135 patients were allocated extracorporeal shock wave therapy and 137 were allocated placebo. Main outcome measures Primary end point was the success rate 12 weeks after intervention based on the Roles and Maudsley score. Secondary end points encompassed subjective pain ratings and walking ability up to a year after the last intervention. Results The primary end point could be assessed in 94% (n=256) of patients. The success rate 12 weeks after intervention was 34% (n=43) in the extracorporeal shock wave therapy group and 30% (n=39) in the placebo group (95% confidence interval − 8.0% to 15.1%). No difference was found in the secondary end points. Few side effects were reported. Conclusions Extracorporeal shock wave therapy is ineffective in the treatment of chronic plantar fasciitis.

„Extracorporeal shock wave therapy for plantar fasciitis–a double blind randomised controlled trial”︁ by C. A. Speed et al., J Orthop res 2003;21:937‐40

“…The study of Buchbinder was of excellent quality but there were clear differences regarding our trial. First, patients in the active group did not receive identical treatment (either 2000 or 2500 shock waves per treatment of energy levels varying between 0.02 and 0.33 mJ/mm2) contrary to the current study [4]. Second, the mean dose in the active group was 1407, 500 mJ/mm2 more than in the current study.…”

“…I congratulate them for the well-conducted randomised controlled trial, the negative results of which contrast with our and others recently published experience [2,5] and confirm data of the Australian multicenter study [3] and of the German multi-center study [4].…”

“…With regard to the German multi-center trial published by Haake et al [4] in the BMJ the study design is excellent. It was a randomised, blinded, multi-center trial with parallel-group design.…”

Electrohydraulic High-Energy Shock-Wave Treatment for Chronic Plantar Fasciitis

“…Other studies on low-energy electromagnetic shock waves in which patients received the same dosage and those treated with a placebo received no shock waves, with delivery in a transverse direction, also showed no effective difference between the actively treated patients and the patients who received the placebo 50,51 . Those studies (compared with the present study on high-energy electrohydraulic shock waves) sug-gested that there are different tissue responses to shock waves contingent upon the method of generation (electrohydraulic or electromagnetic), the level of energy applied, or the direction of delivery (perpendicular to the plantar surface or transverse).…”

“…Extracorporeal shock-wave treatments have been applied to patients with chronic plantar fasciitis who have failed to respond to multiple conservative pharmacologic and therapeutic interventions [29][30][31][32][33][34][35][36][37][38] . Recent randomized, controlled stud- ies have been published but with varying results because of differences in study design, direction of the shock-wave delivery, energy levels, size (volume) of the focused energy ellipsoid (f 2 ) that is transcutaneously transmitted to the fascia, and method of forming the shock wave (electrohydraulic, electromagnetic, and piezoelectric) 32,[39][40][41][42][43][44][45][46][47][48][49][50][51][52] . One study found that satisfactory results were maintained five years following electromagnetic shock-wave treatment 43 .…”