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

Summary

"Tennis elbow" is the most common cause of lateral elbow pain, generally caused by either work or sports related repetitive strain. In this condition, a tendon along the outside of the elbow becomes inflamed leading to pain, especially with flexing and extending the elbow.

Many treatments have been attempted, including physiotherapy and steroids, with little success. One treatment which has been very effective is the injection of the patients own blood (taken from their other non-affected arm) into their abnormal tendon. The blood recruits the patients own healing factors and heals the damaged tendon. As platelets are thought to be largely responsible, injection of concentrated platelets, extracted from the patient's blood (platelet rich plasma) is a newer, but expensive, technique.

At this point, it is unclear whether whole blood, concentrated platelets, or simply passing a ultrasound-guided needle through the abnormal tendon as a means to stimulate tissue healing (tendon fenestration) is the better treatment.

The objective of this trial is to compare platelet rich plasma, whole blood, dry needle tendon fenestration, and sham injection (with physical therapy) to identify the best and most cost-effective therapy for this debilitating condition.

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.

Sponsors & Collaborators

• Arthrex, Inc.

  collaborator INDUSTRY

• The Physicians' Services Incorporated Foundation

  collaborator OTHER

• Radiological Society of North America

  collaborator OTHER

• McMaster University

  lead OTHER

Principal Investigators

• Mary M Chiavaras, MD, PhD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2023-04-30

Completion

2023-04-30

Countries

• United States
• Canada

Study Locations