Trials / Withdrawn
WithdrawnNCT02668510
RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort
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
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Edna Rath · Federal
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | platelet rich plasma | 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 |
| DRUG | Normal saline | placebo injection of normal saline immediately following shockwave therapy |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2023-12-11
- Completion
- 2023-12-11
- First posted
- 2016-01-29
- Last updated
- 2025-09-25
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02668510. Inclusion in this directory is not an endorsement.