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

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.

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.