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BMJ 2003;327:75 (12 July), doi:10.1136/bmj.327.7406.75
Michael Haake, associate assistant professor1, Mathias Buch, assistant medical director2, Carsten Schoellner, senior resident3, Felix Goebel, senior resident4, Martin Vogel, senior resident5, Ingo Mueller, senior resident6, Jörg Hausdorf, senior registrar7, Karin Zamzow, data manager8, Carmen Schade-Brittinger, head of coordinating centre for clinical trials9, Hans-Helge Mueller, senior biostatistician10
1 Orthopädische Klinik, Universität Regensburg, 93077 Bad Abbach, Germany, 2 Orthopädische Klinik Kassel, 43131 Kassel, Germany, 3 Orthopädische Klinik, Johannes Gutenberg Universität Mainz, 55131 Mainz, Germany, 4 Klinik für Orthopädie, Martin Luther Universität Halle, 06097 Halle, Germany, 5 Rehbergklinik St Andreasberg, 37444 St Andreasberg, Germany, 6 Orthopädische Klinik, Christian-Albrechts-Universität Kiel, 24105 Kiel, Germany, 7 Orthopädische Klinik, Ludwig Maximilians Universität München, 81377 München, Germany, 8 Medizinische Biometrie und Epidemiologie, Philipps-Universität Marburg, 35033 Marburg, Germany, 9 Koordinierungszentrum Klinische Studien, Philipps-Universität Marburg, 10 Medizinische Biometrie und Epidemiologie, Philipps-Universität Marburg
Correspondence to: M Haake m.haake{at}rheumaortho-zentrum.de
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.
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