100
Participants
Start Date
August 31, 2012
Primary Completion Date
April 30, 2023
Study Completion Date
April 30, 2023
Platelet Rich Plasma (PRP) Injection
"1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.~2. A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.~3. For the PRP preparation, the Arthrex ACP system will be used. This is a closed, double syringe system which uses 16 mL of whole blood drawn from the patient's contralateral arm, using a 19G butterfly needle. The blood is centrifuged at 1500 rpm for 5 minutes and extracts 4-7 ml of PRP. No anticoagulant will be used.~4. Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.~5. The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations."
Whole Blood Injection
"1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.~2. A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.~3. 6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.~4. Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.~5. The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations."
Dry Needle Fenestration
"1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.~2. 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.~3. A 22-gauge needle will then be placed into the tendon.~4. 15-25 strokes or as many strokes required until tendon is softened of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon."
Sham Injection
"1. The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic.~2. 3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.~3. The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected."
University of Michigan, Ann Arbor
Hamilton General Hospital, Hamilton
Collaborators (1)
Arthrex, Inc.
INDUSTRY
The Physicians' Services Incorporated Foundation
OTHER
Radiological Society of North America
OTHER
McMaster University
OTHER