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

NCT01668953 | Terminated DMC

• 2 other identifiers: IMPROVE-001Research Seed Grant # 1204
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

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)

Keywords

Lateral Epicondylitis; Tennis Elbow; Platelet Rich Plasma; Whole Blood; Tendon Fenestration

Outcome Measures

Primary Outcomes (1)

• Pain Reduction

  Pain reduction will be measured using the Visual Analog Scale (VAS), a subjective scale in which the patient rates their pain on a scale from 0 to 10 (0, no pain, 10, maximum possible pain).

  Baseline, 6 weeks, 3, 6, 12 months

Secondary Outcomes (3)

• Functional Disability

  Baseline, 6 weeks, 3, 6, 12, 24 months

• Psychological Impairment

  Baseline, 6 weeks, 3, 6, 12, 24 months

• Health-Related Quality of Life

  Baseline, 6 weeks, 3, 6, 12, 24 months

Study Arms (4)

Platelet Rich Plasma (PRP) Injection

EXPERIMENTAL

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.

Other: Platelet Rich Plasma (PRP) Injection

Whole Blood Injection

ACTIVE COMPARATOR

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

Other: Whole Blood Injection

Dry Needle Fenestration

ACTIVE COMPARATOR

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.

Other: Dry Needle Fenestration

Sham Injection

PLACEBO COMPARATOR

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

Other: Sham Injection

Interventions

Platelet Rich Plasma (PRP) Injection 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.

Platelet Rich Plasma (PRP) Injection

Whole Blood Injection 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.

Whole Blood Injection

Dry Needle Fenestration 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.

Dry Needle Fenestration

Sham Injection 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.

Sham Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• McMaster University: lead
• Arthrex, Inc.: collaborator
• The Physicians' Services Incorporated Foundation: collaborator
• Radiological Society of North America: collaborator

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109-5326, United States

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (1)

• 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.

  PMID: 34590307 DERIVED

MeSH Terms

Conditions

Tennis Elbow

Interventions

Injections; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Mary M Chiavaras, MD, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2012
• First Posted: August 20, 2012
• Study Start: August 1, 2012
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 10, 2023

Record last verified: 2023-04

Locations

CA (1); US (1)