Treatment of Plantar Fasciitis With Platelet Rich Plasma

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
William Bunnell, Loma Linda University
ClinicalTrials.gov Identifier:
NCT01127672
First received: May 19, 2010
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Plantar Fasciitis
Biological: platelet rich plasma
Drug: corticosteroid injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Platelet Rich Plasma Injection Compared to Corticosteroid Injection for Treatment of Plantar Fasciitis. A Prospective, Randomized Control Trial

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • Pain and Disability of the Foot and Ankle Through Validated Questionnaires [ Time Frame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma ] [ Designated as safety issue: No ]
    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.


Enrollment: 0
Study Start Date: May 2010
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: control
corticosteroid injection into the origin of the plantar fascia
Drug: corticosteroid injection

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.

Other Names:
  • betamethasone injectable suspension
  • xylocaine
Active Comparator: experimental
platelet rich plasma injection into the origin of the plantar fascia
Biological: platelet rich plasma

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.

Other Names:
  • platelet rich plasma - PRP
  • xylocaine

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01127672

Locations
United States, California
Loma Linda University Orthopaedic Center
San Bernadino, California, United States, 92408
Sponsors and Collaborators
Loma Linda University
Investigators
Principal Investigator: William P Bunnell, MD Loma Linda University Department of Orthopaedics
  More Information

Publications:
Responsible Party: William Bunnell, Medical Doctor, Loma Linda University
ClinicalTrials.gov Identifier: NCT01127672     History of Changes
Other Study ID Numbers: 59295
Study First Received: May 19, 2010
Last Updated: April 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Loma Linda University:
plantar fasciitis
PRP
platelet rich plasma

Additional relevant MeSH terms:
Fasciitis
Fasciitis, Plantar
Musculoskeletal Diseases
Foot Diseases
Betamethasone
Lidocaine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anti-Arrhythmia Agents
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014