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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
immediately following shockwave therapy the injection of PRP derived from subjects own blood using Arthex double syringe system will be injected at the origin of the plantar fascia at the calcaneous
placebo injection of normal saline immediately following shockwave therapy
William Beaumont Army Medical Center
El Paso, Texas, United States
Visual analog scale (VAS)
Decreased first step pain over time with single treatment of ESWT \& PRP as measured by the VAS
Time frame: 3, 6, 12, 24 weeks
Functional Ankle Ability Measure (FAAM)
functionality scale
Time frame: 3, 6, 12, 24 weeks
Functional Ankle Ability Measure extended sports scale
sports subscale for sport related activity
Time frame: 3, 6, 12, 24 weeks
return to activity
achieving minimal clinical important difference (MCID) on FAAM sport scale
Time frame: 3, 6, 12, 24 weeks
repeat treatment threshold
Decreased need for repeat ESWT as proven by achieving MCID on FAAM
Time frame: 3, 6, 12, 24 weeks
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