Clinical trial NCT01668953: Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis)
Official title: Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lateral Epicondylitis (Tennis Elbow)
Keywords: Lateral Epicondylitis
Tennis Elbow
Platelet Rich Plasma
Whole Blood
Tendon Fenestration
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Arthrex, Inc.
name: The Physicians' Services Incorporated Foundation
name: Radiological Society of North America
First posted: 2012-08-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Pain Reduction
timeFrame: Baseline, 6 weeks, 3, 6, 12 months
Secondary outcomes:
measure: Functional Disability
timeFrame: Baseline, 6 weeks, 3, 6, 12, 24 months
measure: Psychological Impairment
timeFrame: Baseline, 6 weeks, 3, 6, 12, 24 months
measure: Health-Related Quality of Life
timeFrame: Baseline, 6 weeks, 3, 6, 12, 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
Study officials:
affiliation: McMaster University
name: Mary M Chiavaras, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.