Clinical Trial: RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: 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 Fascii
Brief Summary: 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
Detailed Summary: 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.
Sponsor: William Beaumont Army Medical Center
Current Primary Outcome: Visual analog scale (VAS) [ Time Frame: 3, 6, 12, 24 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Functional Ankle Ability Measure (FAAM) [ Time Frame: 3, 6, 12, 24 weeks ]functionality scale
- Functional Ankle Ability Measure extended sports scale [ Time Frame: 3, 6, 12, 24 weeks ]sports subscale for sport related activity
- return to activity [ Time Frame: 3, 6, 12, 24 weeks ]achieving minimal clinical important difference (MCID) on FAAM sport scale
- repeat treatment threshold [ Time Frame: 3, 6, 12, 24 weeks ]Decreased need for repeat ESWT as proven by achieving MCID on FAAM
Original Secondary Outcome: Same as current
Information By: William Beaumont Army Medical Center
Dates:
Date Received: January 26, 2016
Date Started: January 2016
Date Completion: March 2018
Last Updated: May 12, 2017
Last Verified: May 2017