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

BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7406.75 (Published 10 July 2003) Cite this as: BMJ 2003;327:75
  1. Michael Haake, associate assistant professor (m.haake{at}rheumaortho-zentrum.de)1,
  2. Mathias Buch, assistant medical director2,
  3. Carsten Schoellner, senior resident3,
  4. Felix Goebel, senior resident4,
  5. Martin Vogel, senior resident5,
  6. Ingo Mueller, senior resident6,
  7. Jörg Hausdorf, senior registrar7,
  8. Karin Zamzow, data manager8,
  9. Carmen Schade-Brittinger, head of coordinating centre for clinical trials9,
  10. Hans-Helge Mueller, senior biostatistician10
  1. 1Orthopädische Klinik, Universität Regensburg, 93077 Bad Abbach, Germany
  2. 2Orthopädische Klinik Kassel, 43131 Kassel, Germany
  3. 3Orthopädische Klinik, Johannes Gutenberg Universität Mainz, 55131 Mainz, Germany
  4. 4Klinik für Orthopädie, Martin Luther Universität Halle, 06097 Halle, Germany
  5. 5Rehbergklinik St Andreasberg, 37444 St Andreasberg, Germany
  6. 6Orthopädische Klinik, Christian-Albrechts-Universität Kiel, 24105 Kiel, Germany
  7. 7Orthopädische Klinik, Ludwig Maximilians Universität München, 81377 München, Germany
  8. 8 Medizinische Biometrie und Epidemiologie, Philipps-Universität Marburg, 35033 Marburg, Germany
  9. 9Koordinierungszentrum Klinische Studien, Philipps-Universität Marburg
  10. 10Medizinische Biometrie und Epidemiologie, Philipps-Universität Marburg
  1. Correspondence to: M Haake
  • Accepted 15 April 2003

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.

Footnotes

  • Contributors MH was the principal investigator and will act as guarantor for the paper. MB, MH, and HHM designed the study. HHM was the biostatistician. CSB coordinated the study. HHM and KZ analysed the data. MH, HHM, CSB, and KZ prepared and finalised the paper. All authors interpreted the results, commented on the first draft, and approved the final version.

  • Funding This trial was supported by the Deutsche Forschungsgemeinschaft (grant No 1079/2-1), the German Association for Orthopaedics and Orthopaedic Surgery, and the Association for Promoting Science and Research at the Rehberg Clinic, Germany. Dornier Medizintechnik Germany provided us with the shock wave equipment. They had no involvement in, or control over, the conduct of the study or the content of this paper.

  • Competing interests Ethical approval: The study protocol was approved by the local ethics committees of the principal investigator (approval No 83/98) and the participating centres.

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