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A Randomized Controlled Pilot Trial Comparing Extracorporeal Shock Wave Therapy with Platelet Rich Plasma versus Extracorporeal Shock Wave Therapy in a High Demand Cohort with Resistant Plantar Fasciitis
Full description
The purpose of this proposal is to perform a high-quality pilot study testing the efficacy of ESWT in combination with PRP for the management of resistant plantar fasciitis. We endeavor to determine if the pilot evidence supports a large, randomized study; and to conduct a power analysis for the follow-on study. The proposed pilot study will be a prospective double-blinded randomized controlled trial comparing pain and functionality at the 3 week, 6 week, 12 week and 6 month marks between extracorporeal shock wave therapy (ESWT) with platelet rich plasma (PRP) injection versus extracorporeal shock wave therapy with placebo injection of normal saline.
Enrollment
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Inclusion criteria
Exclusion criteria
• History of trauma* or previous injury to heel requiring operative intervention
All Soldiers pending medical board evaluation or punitive action
History of connective tissue disorder (e.g., Marfan's Syndrome, Ehlers-Danlos disease, Rheumatoid Arthritis, etc.)
Leaving the geographical area permanently or for extended periods of time forcing loss to follow up
Treatment for plantar fasciitis with injection within the last 6 months
Surgical indication or internal derangement of the foot
Chronic pain conditions
Pregnancy
Tarsal tunnel syndrome
Baxter's neuritis
Rigid flat foot
Active infection of the Foot overlying the injection area
Use of immunomodulators, immunosuppressives, or chemotherapeutic agents
Allergy or hypersensitivity to any of the proposed treatment medications
Any other clinically significant acute or chronic medical conditions (e.g., bleeding disorder) that, in the judgment of the Investigator, would preclude the use of a PRP or that could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study.
Primary purpose
Allocation
Interventional model
Masking
30 participants in 2 patient groups, including a placebo group
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Central trial contact
Timothy B Pekari, DSc; Justin D Orr, MD
Data sourced from clinicaltrials.gov
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