Fasciitis, Plantar
Conditions
Keywords
Heel Pain, extracorporeal shock wave therapy, ESWT, shock wave, Soldiers, Platelet rich plasma, PRP, Autologous conditioned plasma, Military
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.
Interventions
BIOLOGICALplatelet 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
DRUGNormal saline
placebo injection of normal saline immediately following shockwave therapy
Sponsors
Edna Rath
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed