Clinical trial NCT01127672: Treatment of Plantar Fasciitis With Platelet Rich Plasma
Official title: Platelet Rich Plasma Injection Compared to Corticosteroid Injection for Treatment of Plantar Fasciitis. A Prospective, Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Plantar Fasciitis
Keywords: plantar fasciitis
PRP
platelet rich plasma
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2010-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pain and Disability of the Foot and Ankle Through Validated Questionnaires
timeFrame: 15 minutes prior to initial injection of corticosteroid versus platelet rich plasma
measure: Pain and Disability of the Foot and Ankle through Validated Questionnaires
timeFrame: 6 weeks from initial injection of corticosteroid versus platelet rich plasma
measure: Pain and Disability of the Foot and Ankle through Validated Questionnaires
timeFrame: 12 weeks from initial injection of corticosteroid versus platelet rich plasma
Secondary outcomes:
Other outcomes:
Locations:
city: San Bernadino
country: United States
facility: Loma Linda University Orthopaedic Center
state: California
Study officials:
affiliation: Loma Linda University Department of Orthopaedics
name: William P Bunnell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: League AC. Current concepts review: plantar fasciitis. Foot Ankle Int. 2008 Mar;29(3):358-66. doi: 10.3113/FAI.2008.0358. No abstract available.
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.
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. doi: 10.3113/FAI.2007.0984.
citation: 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. doi: 10.1177/107110079401500701.
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.
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. doi: 10.1177/0363546506288850. Epub 2006 May 30.
citation: Barrett S, Erredge S. Growth factor for chronic plantar fasciitis. Podiatry Today. 17: 37-42, 2004.