Treatment of Plantar Fasciitis With Platelet Rich Plasma

Not Applicable

Withdrawn

• Conditions: Plantar Fasciitis
• Interventions: Biological: platelet rich plasma; Drug: corticosteroid injection

• Registration Number: NCT01127672
• Lead Sponsor: Loma Linda University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-19
• Study First Submitted QC: 2010-05-19
• Study First Posted: 2010-05-21
• Primary Completion: 2011-05
• Study Completion: 2011-05
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-15
• Last Update Posted: 2014-04-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
experimental	platelet rich plasma	platelet rich plasma injection into the origin of the plantar fascia
control	corticosteroid injection	corticosteroid injection into the origin of the plantar fascia

Primary Outcome Measures

Name	Time	Method
Pain and Disability of the Foot and Ankle Through Validated Questionnaires	15 minutes prior to initial injection of corticosteroid versus platelet rich plasma	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.
Pain and Disability of the Foot and Ankle through Validated Questionnaires	12 weeks from initial injection of corticosteroid versus platelet rich plasma	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.

Trial Locations

Locations (1)

Loma Linda University Orthopaedic Center; 🇺🇸 San Bernadino, California, United States