Treatment of Plantar Fasciitis With Platelet Rich Plasma

Study Overview
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Brief Summary
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The purpose of this investigator-initiated study is to clinically evaluate the efficacy of a new treatment for plantar fasciitis. This treatment consists of a platelet rich plasma injection into the origin of the plantar fascia. It is thought that plasma rich plasma injection will dramatically improve outcomes for patients suffering from plantar fasciitis. Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma into the origin of the plantar fascia. The control group will undergo a corticosteroid injection into the plantar fascia as the sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at the initial visit prior to receiving the injection, as well as six and twelve weeks post injection. These questionnaires will give insight into functionality and pain changes that the plantar fascia is experiencing due to treatment. Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed. Subjects will be between 18 and 89 years of age. In total, subject participation will last approximately 3 months.

Official Title
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Platelet Rich Plasma Injection Compared to Corticosteroid Injection for Treatment of Plantar Fasciitis. A Prospective, Randomized Control Trial

Conditions
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Plantar Fasciitis

Intervention / Treatment
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* Biological: platelet rich plasma
* Drug: corticosteroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting with complaints of plantar heel pain, worse with rising in morning and/or after periods of sitting or lying presenting for at least 4 weeks Examination reveals maximal tenderness at the attachment of the plantar fascia on the medial tubercle of the calcaneus Willingness to participate in an investigational technique Willingness to forgo any other concomitant conservative treatment modality; NSAIDS and orthotic devices during the study period Exclusion Criteria: Previous surgery for heel pain Nerve related symptoms (radiculopathy, tarsal tunnel syndrome, tarsi sinus syndrome) Patient with complex regional pain syndrome Achilles tendon pathology RA, DM, local or systemic infection, PVD, metabolic disease such as gout, clotting disorder, anticoagulation therapy Patients that are pregnant or breastfeeding Patients with metastatic cancer Dysfunction of the knee, ankle, or foot Work related or compensable injury Previous treatment: corticosteroid injection in the last 6 months or NSAIDs treatment within the last 7 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control<br>corticosteroid injection into the origin of the plantar fascia | Drug: corticosteroid injection<br>* Under sterile conditions, patients will receive a 4 cc injection consisting of 2 cc Celestone Soluspan (6mg/ml) and 2 cc of 1% lidocaine into the origin of the plantar fascia, administered by an orthopedic surgeon. This will be done using a plantar approach. A peppering technique spreading in clockwise manner will be used to achieve a more expansive zone of delivery, with a maximum of 10 passes through the fascia itself. The patient will be monitored for 10 minutes in clinic for adverse reactions.<br>* Other names: xylocaine;|
| Active Comparator: experimental<br>platelet rich plasma injection into the origin of the plantar fascia | Biological: platelet rich plasma<br>* 30 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 3 cc PRP injection (consisting of their own PRP) with 1 cc of 2% lidocaine into the origin of the plantar fascia, administered by an orthopedic surgeon. This will be done using a plantar approach. A peppering technique spreading in clockwise manner will be used to achieve a more expansive zone of delivery, with a maximum of 10 passes through the fascia itself. The patient will be monitored for 10 minutes in clinic for adverse reactions.<br>* Other names: xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain and Disability of the Foot and Ankle Through Validated Questionnaires | Patients will be asked to fill out 3 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, American Orthopaedic Foot and Ankle Society clinical rating system, and the Foot and Ankle Disability Index. All these questionnaires are externally validated clinical outcome measures that rate foot and ankle pain and dysfunction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome. | 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma | 
| Pain and Disability of the Foot and Ankle through Validated Questionnaires | Patients will be asked to fill out 3 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, American Orthopaedic Foot and Ankle Society clinical rating system, and the Foot and Ankle Disability Index. All these questionnaires are externally validated clinical outcome measures that rate foot and ankle pain and dysfunction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome. | 6 weeks from initial injection of corticosteroid versus platelet rich plasma | 
| Pain and Disability of the Foot and Ankle through Validated Questionnaires | Patients will be asked to fill out 3 questionnaires to provide insight into how their condition is progressing. These questionnaires consist of a visual analog pain score, American Orthopaedic Foot and Ankle Society clinical rating system, and the Foot and Ankle Disability Index. All these questionnaires are externally validated clinical outcome measures that rate foot and ankle pain and dysfunction on various numerical scales. With the exception of the visual analogue scale pain score, there is a direct relationship to the score and positive patient outcome. | 12 weeks from initial injection of corticosteroid versus platelet rich plasma | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plantar fasciitis, PRP, platelet rich plasma