Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)

NATerminatedINTERVENTIONAL
Enrollment

100

Participants

Timeline

Start Date

August 31, 2012

Primary Completion Date

April 30, 2023

Study Completion Date

April 30, 2023

Conditions
Lateral Epicondylitis (Tennis Elbow)
Interventions
OTHER

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."

OTHER

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."

OTHER

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."

OTHER

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."

Trial Locations (2)

48109-5326

University of Michigan, Ann Arbor

L8L 2X2

Hamilton General Hospital, Hamilton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Arthrex, Inc.

INDUSTRY

collaborator

The Physicians' Services Incorporated Foundation

OTHER

collaborator

Radiological Society of North America

OTHER

lead

McMaster University

OTHER