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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Active Comparator | corticosteroid injection into the origin of the plantar fascia |
|
| experimental | Active Comparator | platelet rich plasma injection into the origin of the plantar fascia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| platelet rich plasma | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William P Bunnell, MD | Loma Linda University Department of Orthopaedics | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University Orthopaedic Center | San Bernadino | California | 92408 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18348838 | Background | 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. | |
| 19468902 | Background | 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. |
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| ID | Term |
|---|---|
| D036981 | Fasciitis, Plantar |
| ID | Term |
|---|---|
| D005208 | Fasciitis |
| D009140 | Musculoskeletal Diseases |
| D005534 | Foot Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000305 | Adrenal Cortex Hormones |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| corticosteroid injection | Drug | 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. |
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| 17880872 | Background | 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. |
| 7951968 | Background | 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. |
| 19380129 | Background | 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. |
| 16735582 | Background | 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. |
| Background | Barrett S, Erredge S. Growth factor for chronic plantar fasciitis. Podiatry Today. 17: 37-42, 2004. |
| Aniline Compounds |
| D000588 | Amines |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |