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

NCT ID: NCT01668953

Last Updated: 2023-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2023-04-30

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Platelet Rich Plasma (PRP) Injection

Patients in this arm will receive a platelet rich plasma injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.

Group Type: EXPERIMENTAL

Platelet Rich Plasma (PRP) Injection

Intervention Type: OTHER

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

Patients in this arm will receive a whole blood injection at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises.

Group Type: ACTIVE_COMPARATOR

Whole Blood Injection

Intervention Type: OTHER

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

Patients in this arm will receive 15-25 gentle strokes of dry needling (piercing of the tendon) at the site of their lateral epicondylitis, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.

Group Type: ACTIVE_COMPARATOR

Dry Needle Fenestration

Intervention Type: OTHER

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

Patients in this arm will receive a sham injection, followed by post-treatment physical therapy exercises. No blood will be injected into the tendon.

Group Type: PLACEBO_COMPARATOR

Sham Injection

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Adult man or woman aged 18 years or greater.
• Clinical diagnosis of lateral epicondylitis based on site of pain, pain elicited with active extension of the wrist in pronation and elbow extension.
• Documented sonographic diagnosis of common extensor tendinosis based on tendon thickening, areas of hypoechogenicity, and loss of the normal echotexture.
• Chronic symptoms (equal or greater than 3 months).
• Pain of at least 5 out of 10 on a visual analog scale (VAS).
• Provision of informed consent.

Exclusion Criteria

• Acute symptom onset (less than 2 months).
• History of acute elbow trauma (less than one week).
• History of rheumatoid arthritis.
• History of malignancy.
• Pregnancy
• Patients requiring anti-platelet medication for the treatment of heart attack, stroke or other medical condition.
• Previous surgery for lateral epicondylitis.
• Previous local injections, including steroids within the past 6 months.
• Signs of other causes for lateral elbow pain (posterior interosseous nerve entrapment, osteochondral lesion).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arthrex, Inc.

INDUSTRY

Sponsor Role: collaborator

The Physicians' Services Incorporated Foundation

OTHER

Sponsor Role: collaborator

Radiological Society of North America

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mary M Chiavaras, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

University of Michigan

Ann Arbor, Michigan, United States

Hamilton General Hospital

Hamilton, Ontario, Canada

Countries

United States; Canada

References

Karjalainen TV, Silagy M, O'Bryan E, Johnston RV, Cyril S, Buchbinder R. Autologous blood and platelet-rich plasma injection therapy for lateral elbow pain. Cochrane Database Syst Rev. 2021 Sep 30;9(9):CD010951. doi: 10.1002/14651858.CD010951.pub2.

Reference Type: DERIVED

PMID: 34590307 (View on PubMed)

Other Identifiers

Research Seed Grant # 1204

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IMPROVE-001

Identifier Type: -

Identifier Source: org_study_id

NCT01789632

Identifier Type: -

Identifier Source: nct_alias