Treatment of Plantar Fasciitis With Platelet Rich Plasma
NCT ID: NCT01127672
Last Updated: 2014-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2010-05-31
2011-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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control
corticosteroid injection into the origin of the plantar fascia
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.
experimental
platelet rich plasma injection into the origin of the plantar fascia
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.
Interventions
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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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
89 Years
ALL
No
Sponsors
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Loma Linda University
OTHER
Responsible Party
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William Bunnell
Medical Doctor
Principal Investigators
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William P Bunnell, MD
Role: PRINCIPAL_INVESTIGATOR
Loma Linda University Department of Orthopaedics
Locations
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Loma Linda University Orthopaedic Center
San Bernadino, California, United States
Countries
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References
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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.
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. doi: 10.3113/FAI.2007.0984.
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.
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. doi: 10.1177/0363546506288850. Epub 2006 May 30.
Barrett S, Erredge S. Growth factor for chronic plantar fasciitis. Podiatry Today. 17: 37-42, 2004.
Other Identifiers
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59295
Identifier Type: -
Identifier Source: org_study_id
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