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Randomized, Placebo-Controlled, Double-Blind Clinical Trial Evaluating the Treatment of Plantar Fasciitis with an Extracorporeal Shockwave Therapy (ESWT) Device: A North American Confirmatory Study
Patricia Kudo,1 Katie Dainty,1 Michael Clarfield,2 Larry Coughlin,3 Pauline Lavoie,4 Constance Lebrun1
1 2 3

Fowler Kennedy Sport Medicine Clinic, 3M Centre University of Western Ontario, London, Ontario N6A 3K7, Canada The Sports Medicine Specialists, 150 Eglinton Avenue East, Toronto, Ontario M4P 1E8, Canada

West Island Orthopedic & Sports Medicine Center, 3881 Boulevard St-Jean Dollard-des-Ormeaux, Quebec H9G 2V1, Canada
4

Action Sport Physio, 1451 rue Montarville, St-Bruno, Quebec J3V 3T6, Canada

Received 2 December 2004; accepted 16 May 2005 Published online 18 November 2005 in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/jor.20008

ABSTRACT: Despite numerous publications and clinical trials, the results of treatment of recalcitrant chronic plantar fasciitis with extracorporeal shockwave therapy (ESWT) still remain equivocal as to whether or not this treatment provides relief from the pain associated with this condition. The objective of this study was to determine whether extracorporeal shock wave therapy can safely and effectively relieve the pain associated with chronic plantar fasciitis compared to placebo treatment, as demonstrated by pain with walking in the morning. This was set in a multicenter, randomized, placebo-controlled, double-blind, confirmatory clinical study undertaken in four outpatient orthopedic clinics. The patients, 114 adult subjects with chronic plantar fasciitis, recalcitrant to conservative therapies for at least 6 months, were randomized to two groups. Treatment consisted of approximately 3,800 total shock waves (Æ10) reaching an approximated total energy delivery of 1,300 mJ/mm2 (EDþ) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment