To the Editor:
We are writing regarding an article published in the November/December 2005 issue of the Journal by Donald M. Norris, MD, Kimberly M. Eickmeier, DPM, and Bruce R. Werber, DPM, titled “Effectiveness of Extracorporeal Shockwave Treatment in 353 Patients with Chronic Plantar Fasciitis.” We have two issues we wish to raise concerning this article.
First, we are concerned about the conclusions the authors make that “extracorporeal shockwave treatment reduces the pain associated with chronic plantar fasciitis and increases mobility” (p 523). Unfortunately, the results of this survey do not support this conclusion. The authors, quite rightly, have discussed the weaknesses of this study—the two most important being that they did not compare extracorporeal shockwave treatment (ESWT) with a control group, and the outcome measure was not validated.
In addition to these limitations, there is another fundamental limitation that was not discussed: only 353 out of 874 patients (40.4%) provided a usable response to this survey. This of course could mean that, at worst, 521 out of 874 patients (59.6%) did not have a reduction in pain and an increase in mobility. Without the data for these 521 patients, we simply do not know the true outcome. We recognize that obtaining a high response rate for a survey of this type is difficult; however, the authors should have discussed this as one of the primary limitations of their study. Combining this with the limitations they did discuss, the conclusions from this study should have been more cautious.
There are already multiple randomized trials[1–13]—that is, high-level evidence—that have evaluated this intervention and have been published in English-language journals. Moreover, Thomson et al[14] recently published a systematic review (with meta-analysis)—the highest form of evidence—assessing whether ESWT is effective. Our aim with this letter is not to enter into a debate on whether this intervention is effective or not. However, we encourage readers interested in this treatment to read the article by Thomson and colleagues, because it represents an up-to-date and unbiased review of this fascinating treatment. On the basis of pooled data from six trials (involving 897 participants), Thomson et al concluded that ESWT is more effective than a placebo, but the effect size was very small. Interestingly, when the two lowest-quality trials were excluded, no significant treatment effect was apparent.
The second issue we would like to raise in relation to this article is the primary author’s conflict of interest. The guidelines of the International Committee of Medical Journal Editors (ICMJE) state:
Conflict of interest exists when an author (or the author’s institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties). . . . Financial relationships (such as employment, consultancies, stock ownership, honoraria, paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself.[15]
JAPMA’s editorial policy[16] requires that the author(s) of a submitted manuscript disclose any potential conflicts of interest by responding to the following statement on the copyright transfer form: “The author(s) has no financial interest in the drugs, devices, or procedures described herein. In addition, the author(s) has no financial relationship that might lead to a conflict of interest.”
No conflict-of-interest disclosure statement appears in the Norris et al article, yet the primary author’s affiliation is listed as “United Shockwave Therapies,” a company that owns and operates Dornier Epos Ultra ESWT devices and describes itself as “the premier healthcare operator of fixed-site and mobile shockwave therapy systems throughout the country.”[17] This appears to be a clear conflict of interest according to the ICMJE definition and one that should have been disclosed in the article.
In closing, while we applaud the efforts of Dr. Norris and colleagues in attempting to evaluate the efficacy of ESWT, we have concerns regarding the scientific rigor of the study. We therefore advise podiatric physicians to refer to the conclusions of recent systematic reviews and randomized controlled trials for a more valid and precise estimate of the treatment’s effectiveness. Finally, it is disappointing that the primary author’s conflict of interest was not disclosed, and we hope that JAPMA takes adequate measures to prevent similar situations from arising in the future.
References
- Buchbinder R, Ptasznik R, Gordon J, et al: Ultrasound-guided extracorporeal shock wave therapy for plantar fasciitis: a randomized controlled trial. .JAMA288::1364. ,2002. .
- Cosentino R, Falsetti P, Manca S, et al: Efficacy of extracorporeal shock wave treatment in calcaneal enthesophytosis. .Ann Rheum Dis60::1064. ,2001. .
- Haake M, Buch M, Schoellner C, et al: Extracorporeal shock wave therapy for plantar fasciitis: randomised controlled multicentre trial. .BMJ327::75. ,2003. .
- Hammer DS, Adam F, Kreutz A, et al: Extracorporeal shockwave therapy (ESWT) in patients with chronic proximal plantar fasciitis: a 2-year follow-up. .Foot Ankle Int24::823. ,2003. .
- Hammer DS, Rupp S, Kreutz A, et al: Extracorporeal shockwave therapy (ESWT) in patients with chronic proximal plantar fasciitis. .Foot Ankle Int23::309. ,2002. .
- Ogden JA, Alvarez RG, Levitt R, et al: Shock wave therapy for chronic proximal plantar fasciitis. .Clin Orthop Relat Res387::47. ,2001. .
- Ogden JA, Alvarez RG, Levitt RL, et al: Electrohydraulic high-energy shock-wave treatment for chronic plantar fasciitis. .J Bone Joint Surg Am86::2216. ,2004. .
- Rompe JD, Decking J, Schoellner C, et al: Shock wave application for chronic plantar fasciitis in running athletes: a prospective, randomized, placebo-controlled trial. .Am J Sports Med31::268. ,2003. .
- Rompe JD, Hopf C, Nafe B, et al: Low-energy extracorporeal shock wave therapy for painful heel: a prospective controlled single-blind study. .Arch Orthop Trauma Surg115::75. ,1996. .
- Rompe JD, Kullmer K, Riehle H-M, et al: Effectiveness of low-energy extracorporal shock waves for chronic plantar fasciitis. .Foot Ankle Surg2::215. ,1996. .
- Rompe JD, Meurer A, Nafe B, et al: Repetitive low-energy shock wave application without local anesthesia is more efficient than repetitive low-energy shock wave application with local anesthesia in the treatment of chronic plantar fasciitis. .J Orthop Res23::931. ,2005. .
- Rompe JD, Schoellner C, Nafe B: Evaluation of low-energy extracorporeal shock-wave application for treatment of chronic plantar fasciitis. .J Bone Joint Surg Am84::335. ,2002. .
- Speed CA, Nichols D, Wies J, et al: Extracorporeal shock wave therapy for plantar fasciitis: a double blind randomised controlled trial. .J Orthop Res21::937. ,2003. .
- Thomson CE, Crawford F, Murray GD: The effectiveness of extra corporeal shock wave therapy for plantar heel pain: a systematic review and meta-analysis. .BMC Musculoskelet Disord6::19. ,2005. .
- International Committee of Medical Journal Editors: Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Available at: http://www.icmje.org. Accessed November 24. ,2005. .
- Joseph WS: Ethical issues in medical journal editing. .JAPMA90::465. ,2000. .
- United Shockwave Therapies Web site. Available at: http://www.unitedshockwave.com/. Accessed November 24. ,2005. .
© 2006 American Podiatric Medical Association