Treatment of Plantar Fasciitis With Platelet Rich Plasma
Information source: Loma Linda University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Plantar Fasciitis
Intervention: platelet rich plasma (Biological); corticosteroid injection (Drug)
Phase: N/A
Status: Withdrawn
Sponsored by: Loma Linda University Official(s) and/or principal investigator(s): William P Bunnell, MD, Principal Investigator, Affiliation: Loma Linda University Department of Orthopaedics
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.
Clinical Details
Official title: Platelet Rich Plasma Injection Compared to Corticosteroid Injection for Treatment of Plantar Fasciitis. A Prospective, Randomized Control Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pain and Disability of the Foot and Ankle Through Validated QuestionnairesPain and Disability of the Foot and Ankle through Validated Questionnaires Pain and Disability of the Foot and Ankle through Validated Questionnaires
Eligibility
Minimum age: 18 Years.
Maximum age: 89 Years.
Gender(s): Both.
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
Locations and Contacts
Loma Linda University Orthopaedic Center, San Bernadino, California 92408, United States
Additional Information
Related publications: League AC. Current concepts review: plantar fasciitis. Foot Ankle Int. 2008 Mar;29(3):358-66. doi: 10.3113/FAI.2008.0358. Review. 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. 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. 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. 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. 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. Barrett S, Erredge S. Growth factor for chronic plantar fasciitis. Podiatry Today. 17: 37-42, 2004.
Starting date: May 2010
Last updated: April 15, 2014
|