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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 2005in 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 studywas 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 betweentreatment groups in the change from baseline to 3 months in the primary efficacy outcome of pain during the first few minutes of walking measured by a visual analog scale. There was also a statistically significant difference between treatments in the number of participants whose changes in Visual Analog Scale scores met the study definition of success at both 6 weeks and 3 months posttreatment; andbetween treatment groups in the change from baseline to 3 months posttreatment in the Roles and Maudsley Score. The results of this study confirm that ESWT administered with the Dornier Epos Ultra is a safe and effective treatment for recalcitrant plantar fasciitis. ß 2005 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 24:115–123, 2006

Keywords:

plantarfasciitis; shock wave therapy; heel pain; ESWT

INTRODUCTION
In the past 20 years extracorporeal shock waves have been used to safely and effectively treat a number of medical conditions. Shock wave lithoCorrespondence to: Katie Dainty (Telephone: 416-480-6100, ext. 7227; E-mail: katie.dainty@sw.ca)
ß 2005 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.

tripsy (ESWL) has beenwell established for over 20 years for the treatment of urologic conditions,1 and more recently, there has been significant interest in orthopedic applications such as nonunion fractures and several types of tendonopathies. Despite numerous publications and clinical trials, one orthopedic application of ESWT, which still remains highly equivocal, is the treatment of chronic plantar fasciitis.JOURNAL OF ORTHOPAEDIC RESEARCH FEBRUARY 2006

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KUDO ET AL.

Plantar fasciitis is defined as a tensile overload of the plantar fascia at its origin on the medial tubercle of the calcaneus.15 The plantar fascia is a thick fibrous tissue on the bottom of the foot that protects sensitive plantar structures such as nerves, vessels, muscles, and tendons, and in addition, is responsible for...
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