Treatment of Plantar Fasciitis With Platelet Rich Plasma

Plantar Fasciitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01127672
• Other study ID #: 59295
• Status: Withdrawn
• Phase: N/A
• First received: May 19, 2010
• Last updated: April 15, 2014
• Start date: May 2010
• Est. completion date: May 2011

Study information

• Verified date: April 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 89 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fasciitis
• Fasciitis, Plantar
• Plantar Fasciitis

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Loma Linda University Orthopaedic Center	San Bernadino	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

References & Publications (7)

Barrett S, Erredge S. Growth factor for chronic plantar fasciitis. Podiatry Today. 17: 37-42, 2004.

Kitaoka HB, Alexander IJ, Adelaar RS, Nunley JA, Myerson MS, Sanders M. Clinical rating systems for the ankle-hindfoot, midfoot, hallux, and lesser toes. Foot Ankle Int. 1994 Jul;15(7):349-53. — View Citation

Kon E, Filardo G, Delcogliano M, Presti ML, Russo A, Bondi A, Di Martino A, Cenacchi A, Fornasari PM, Marcacci M. Platelet-rich plasma: new clinical application: a pilot study for treatment of jumper's knee. Injury. 2009 Jun;40(6):598-603. doi: 10.1016/j.injury.2008.11.026. Epub 2009 Apr 19. — View Citation

League AC. Current concepts review: plantar fasciitis. Foot Ankle Int. 2008 Mar;29(3):358-66. doi: 10.3113/FAI.2008.0358. Review. — View Citation

Lee TG, Ahmad TS. Intralesional autologous blood injection compared to corticosteroid injection for treatment of chronic plantar fasciitis. A prospective, randomized, controlled trial. Foot Ankle Int. 2007 Sep;28(9):984-90. — View Citation

Mishra A, Pavelko T. Treatment of chronic elbow tendinosis with buffered platelet-rich plasma. Am J Sports Med. 2006 Nov;34(11):1774-8. Epub 2006 May 30. — View Citation

Sampson S, Gerhardt M, Mandelbaum B. Platelet rich plasma injection grafts for musculoskeletal injuries: a review. Curr Rev Musculoskelet Med. 2008 Dec;1(3-4):165-74. doi: 10.1007/s12178-008-9032-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No