RCT Comparing ESWT With PRP for Plantar Fasciitis in High Demand Cohort

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Fasciitis, Plantar

Intervention / Treatment
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* Biological: platelet rich plasma
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older Patients that are already selected for ESWT for the treatment of resistant plantar fasciitis as part of clinical care under the doctor-patient relationship X-ray imaging studies (Plain radiographs) documenting no additional sources for heel pain within 12 months(all x-rays were conducted as part of standard of care and no radiation will be specific to the research study) Active Duty Soldier as they are a high demand cohort with increased frequency of plantar fasciitis compared to the general population as outlined by Scher et al. Previously tried conservative management meeting referral to Orthopaedics: Pain medications, taping, orthoses, night splinting or physical therapy Body Mass Index (BMI) <40kg/m2 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. Trauma for this research study is defined as a specific event or mechanism of injury, such as a direct blow or twisting injury of the foot that initiated the onset of heel pain. The insidious onset of heel pain with prolonged running or other physical activity is not defined as a traumatic event.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet Rich Plasma Injection Group<br>shockwave therapy within standard of care using Ossatron system with intervention injection of platelet rich plasma (PRP) using Arthex system, into the plantar fascia at the calcaneal origin | Biological: platelet rich plasma<br>* 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<br>* Other names: PRP;|
| Placebo Comparator: Placebo injection group<br>shockwave therapy with placebo normal saline injection | Drug: Normal saline<br>* placebo injection of normal saline immediately following shockwave therapy<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Decreased first step pain over time with single treatment of ESWT & PRP as measured by the VAS | 3, 6, 12, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Ankle Ability Measure (FAAM) | functionality scale | 3, 6, 12, 24 weeks | 
| Functional Ankle Ability Measure extended sports scale | sports subscale for sport related activity | 3, 6, 12, 24 weeks | 
| return to activity | achieving minimal clinical important difference (MCID) on FAAM sport scale | 3, 6, 12, 24 weeks | 
| repeat treatment threshold | Decreased need for repeat ESWT as proven by achieving MCID on FAAM | 3, 6, 12, 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heel Pain, extracorporeal shock wave therapy, ESWT, shock wave, Soldiers, Platelet rich plasma, PRP, Autologous conditioned plasma, Military