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

William Beaumont Army Medical Center

Status: Unknown

Conditions: Fasciitis, Plantar

Treatments: Drug: Normal saline; Biological: platelet rich plasma

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02668510

16/03

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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30 participants in 2 patient groups, including a placebo group

Platelet Rich Plasma Injection Group

Experimental group

Description:

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

Treatment:

Biological: platelet rich plasma

Placebo injection group

Placebo Comparator group

Description:

shockwave therapy with placebo normal saline injection

Treatment:

Drug: Normal saline