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

Not Applicable

• Conditions: Fasciitis, Plantar
• Interventions: Biological: platelet rich plasma; Drug: Normal saline

• Registration Number: NCT02668510
• Lead Sponsor: William Beaumont Army Medical Center

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 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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Status Verified: 2017-05
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-03
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma Injection Group	platelet rich plasma	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
Placebo injection group	Normal saline	shockwave therapy with placebo normal saline injection

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	3, 6, 12, 24 weeks	Decreased first step pain over time with single treatment of ESWT \& PRP as measured by the VAS

Secondary Outcome Measures

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

Trial Locations

Locations (1)

William Beaumont Army Medical Center; 🇺🇸 El Paso, Texas, United States