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

被引:134
作者
Kudo, P
Dainty, K [1 ]
Clarfield, M
Coughlin, L
Lavoie, P
Lebrun, C
机构
[1] Univ Western Ontario, Fowler Kennedy Sport Med Clin, London, ON N6A 3K7, Canada
[2] Sports Med Specialists, Toronto, ON M4P 1E8, Canada
[3] W Isl Orthoped & Sports Med Ctr, St Jean, PQ H9G 2V1, Canada
[4] Act Sport Phys, St Bruno, PQ J3V 3T6, Canada
关键词
plantar fasciitis; shock wave therapy; heel pain; ESWT;
D O I
10.1002/jor.20008
中图分类号
R826.8 [整形外科学]; R782.2 [口腔颌面部整形外科学]; R726.2 [小儿整形外科学]; R62 [整形外科学(修复外科学)];
学科分类号
摘要
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 shockwaves (+/- 10) reaching an approximated total energy delivery of 1,300 mj/mm(2) (ED+) in a single session versus placebo treatment. This study demonstrated a statistically significant difference between treatment 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; and between 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. (c) 2005 Orthopaedic Research Society. Published by Wiley Periodicals, Inc.
引用
收藏
页码:115 / 123
页数:9
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