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

McMaster University

Status: Terminated

Conditions: Lateral Epicondylitis (Tennis Elbow)

Treatments: Other: Sham Injection; Other: Whole Blood Injection; Other: Platelet Rich Plasma (PRP) Injection; Other: Dry Needle Fenestration

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01668953

IMPROVE-001

Research Seed Grant # 1204 (Other Grant/Funding Number)

Details and patient eligibility

About

"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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 4 patient groups, including a placebo group

Platelet Rich Plasma (PRP) Injection

Experimental group

Description:

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.

Treatment:

Other: Platelet Rich Plasma (PRP) Injection

Whole Blood Injection

Active Comparator group

Description:

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

Treatment:

Other: Whole Blood Injection

Dry Needle Fenestration

Active Comparator group

Description:

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.

Treatment:

Other: Dry Needle Fenestration

Sham Injection

Placebo Comparator group

Description:

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

Treatment:

Other: Sham Injection