Letters to the Editor   |    
Jan D. Rompe, MD1
1 Department of Orthopaedic SurgeryJohannes Gutenberg UniversitySchool ofMedicineLangenbeckstrasse 1D-55131 Mainz, Germanyrompe@mail.uni-mainz.de
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The author did not receive grants or outside funding in support of the research or preparation of this work. The author did not receive payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, educational institution, or other charitable or nonprofit organization with which the author is affiliated or associated.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2005 Mar 01;87(3):681-683
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To The Editor:I read with great interest the article, "Electrohydraulic High-Energy Shock-Wave Treatment for Chronic Plantar Fasciitis" by Ogden et al. (2004;86:2216-28). I congratulate them for reporting the results of the FDA trial, which, to a vast extent, had been published earlier6,7.Some points remain open for discussion.1. The alleged efficacy of this singledose, high-energy, anesthetically based treatment has already been discussed exhaustively by Buchbinder et al.3 in 2002. Regarding the HealthTronics-sponsored FDA trial2, Buchbinder et al. made the criticism that the presence of plantar fasciitis was determined solely on clinical grounds. Also, it was uncertain whether the two groups in the trial were comparable at baseline. In their previous paper, Ogden et al.6 defined overall success of treatment at twelve weeks as fulfillment of four of the following criteria: (1) a minimum 50% improvement over baseline in the investigator's assessment of pain (with a dolorimeter) and a score of £4 cm on a visual analogue scale; (2) a minimum 50% improvement over baseline in the subject's self-assessment of pain on first walking in the morning and a score of £4 cm on a visual analogue scale; (3) a minimum 1-point or greater improvement on a 5-point scale of distance walked without heel pain, or maintenance of a baseline assessment of no pain or minimal pain; and (4) no prescription of analgesics for pain in the treated heel between ten and twelve weeks after treatment. While success according to the three criteria other than the investigator's assessment of pain favored the active treatment, no difference was significant (subject's selfassessment of pain: 59.7% in the shock-wave group compared with 48.2% in the placebo group, p = 0.08; subject's self-assessment of activity level: 71.4% in the shock-wave group compared with 67.2% in the placebo group, p = 0.49; and use of pain medications: 69.7% in the shock-wave group compared with 67% in the placebo group, p = 0.41). I wonder why Ogden et al., who quoted the paper by Buchbinder et al. in their article, did not specifically respond to the objections by those authors. How is it possible that suddenly significant differences were calculated after three months of follow-up while, in the original FDA paper2, no significant difference had been observed after the same duration of follow-up?
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