Original researchExtracorporeal Shockwave Therapy Versus Placebo for the Treatment of Chronic Proximal Plantar Fasciitis: Results of a Randomized, Placebo-Controlled, Double-Blinded, Multicenter Intervention Trial
Section snippets
Materials and Methods
An FDA-approved, randomized, placebo-controlled, double-blinded, multicentered clinical trial to compare the efficacy and safety of the Orthospec device was designed and undertaken at clinical centers in Pennsylvania, Connecticut, and Maryland. Figure 2 schematically depicts the organization and flow of the investigation.
Results
A total of 196 participants were screened, 172 were randomized to treatment, and 152 completed the 12-week efficacy trial. A total of 168 participants had at least 1 follow-up visit and were included in analyses of efficacy. Inspection of the distributions of the data confirmed that our statistical assumptions were met. The 172 participants had a mean age of 51 years, 33% were men, the mean weight was 184 pounds, 87% were white, and the mean duration of foot pain was 30 months. Baseline
Discussion
The Orthospec ESWT device used in this study uses an electrohydraulic, or “spark-gap”, method of creating therapeutic shockwaves. In this system, an electrode ignites an electrical charge within a water-filled, stainless-steel, semi-ellipsoid chamber, evaporating a small portion of the water contained in the chamber and creating a shockwave that is reflected outward. The portable shockwave generator used in this study targets the shockwaves to a 35-mm diameter therapy zone that enables
Summary and Conclusions
The results of this clinical investigation demonstrate the safety and efficacy of the Orthospec Extracorporeal Shockwave Therapy device for treatment of recalcitrant proximal plantar fasciitis. The study achieved statistical significance in its protocol-defined primary endpoint (P = .045), change from baseline in the investigator’s assessment of heel pain at 3 months. When participants were assessed by whether they achieved a clinical response in the primary endpoint, the number of responders
Acknowledgments
We would like to thank Donald R. Green, DPM, Luke D. Cicchinelli, DPM, Alan J. Mlodzienski, DPM, and Michael S. Downey, DPM, for their thoughtful critiques of our manuscript. We would also like to thank Jacqueline Rosenzweig for her assistance in scheduling participants and organizing and maintaining case report forms, and Sheryl Skinner of Medispec LTD for her site management and monitoring efforts.
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Disclosure: This multicenter, double-blinded clinical investigation, entitled protocol PF-01: A Comparative Randomized Placebo-Controlled Clinical Trial of Orthospec™ Versus Orthospec™ Placebo for the Relief of Pain in the Treatment of Proximal Plantar Fasciitis, was conducted under the United States Food and Drug Administration Investigational Device Exemption #G020175 to determine the safety and efficacy of the Orthospec™ ESWT device. The study sponsor, Medispec LTD, 12850 Middlebrook Road, Suite 1, Germantown, MD 20874, provided the extracorporeal shockwave therapy and plantar pressure assessment devices, and funded the investigation.
- 1
Ankle and Foot Medical Centers of the Delaware Valley, Penn-Presbyterian Medical Center, Postdoctoral Research Fellow, Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania School of Medicine, Philadelphia, PA
- 2
Chief, Section of Podiatric Surgery, Yale—New Haven Hospital, Clinical Assistant Professor, Orthopaedics and Rehabilitation, Yale School of Medicine, New Haven Foot Surgeons, New Haven, CT
- 3
Podiatric Director, Shady Grove Wound Center, Shady Grove Podiatry, Gaithersburg, MD
- 4
Chief Resident, Penn—Presbyterian Medical Center, Philadelphia, PA
- 5
Chief Resident, Podiatric Surgery, Yale—New Haven Hospital, New Haven, CT
- 6
Chief Resident, Podiatric Surgery, Yale—New Haven Hospital, New Haven, CT
- 7
Statistical Consultant, Montgomery Village, MD
- 8
Ankle and Foot Medical Centers of the Delaware Valley, Philadelphia, PA
- 9
Shady Grove Podiatry, Gaithersburg, MD