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

April 30, 2018 updated by: William Beaumont Army Medical Center

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

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Army Medical Center

Investigators

  • Principal Investigator: Timothy B Pekari, DSc, WBAMC
  • Principal Investigator: Amanda L Allen, MD, WBAMC
  • Study Director: Lola Norton, WBAMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

May 3, 2018

Last Update Submitted That Met QC Criteria

April 30, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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