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

Sponsor

William Beaumont Army Medical Center (U.S. Fed)

Overall Status

Unknown status

CT.gov ID

NCT02668510

Collaborator

(none)

Enrollment

Location

Arms

37.9

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Fasciitis, Plantar	Biological: platelet rich plasma Drug: Normal saline	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Fasciitis

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2018

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Platelet Rich Plasma Injection Group 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 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 Other Names: PRP
Placebo Comparator: Placebo injection group shockwave therapy with placebo normal saline injection	Drug: Normal saline placebo injection of normal saline immediately following shockwave therapy Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Platelet Rich Plasma Injection Group

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

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

Other Names:

PRP

Placebo Comparator: Placebo injection group

shockwave therapy with placebo normal saline injection

Drug: Normal saline

placebo injection of normal saline immediately following shockwave therapy

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

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

Functional Ankle Ability Measure (FAAM) [3, 6, 12, 24 weeks]
functionality scale
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
repeat treatment threshold [3, 6, 12, 24 weeks]
Decreased need for repeat ESWT as proven by achieving MCID on FAAM

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.