Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) (IMPROVE)
"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.
|Lateral Epicondylitis (Tennis Elbow)||Other: Platelet Rich Plasma (PRP) Injection Other: Whole Blood Injection Other: Dry Needle Fenestration Other: Sham Injection|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis|
- Pain Reduction [ Time Frame: Baseline, 6 weeks, 3, 6, 12 months ]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).
- Functional Disability [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]Functional disability will be measured using the Liverpool Elbow Score (LES) which is an assessment tool for evaluating function based on range of motion, ulnar nerve function, and ability to perform daily activities.
- Psychological Impairment [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]Psychological impairment (depression and anxiety) will be assessed using the Hospital Anxiety and Depression Scale (HADS) which is a reliable, validated, and practical tool for identifying and quantifying anxiety and depression.
- Health-Related Quality of Life [ Time Frame: Baseline, 6 weeks, 3, 6, 12, 24 months ]Health-related quality of life will be measured using the 12-Item Short Form Health Survey (SF-12).
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Experimental: 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.
Other: Platelet Rich Plasma (PRP) Injection
Active Comparator: 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.
Other: Whole Blood Injection
Active Comparator: 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.
Other: Dry Needle Fenestration
Placebo Comparator: 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.
Other: Sham Injection
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668953
|Contact: Mary M Chiavaras, MD, PhD||905-521-2100 ext firstname.lastname@example.org|
|United States, Michigan|
|University of Michigan||Recruiting|
|Ann Arbor, Michigan, United States, 48109-5326|
|Contact: Jon Jacobson, MD email@example.com|
|Hamilton General Hospital||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Contact: Nicole Simunovic, MSc 905-527-4322 ext 44695 firstname.lastname@example.org|
|Principal Investigator: Mary M Chiavaras, MD, PhD|
|Principal Investigator:||Mary M Chiavaras, MD, PhD||McMaster University|