Comparison of Platelet Rich Plasma and Alternative Therapies for the Treatment of Tennis Elbow (Lateral Epicondylitis) (IMPROVE)
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|ClinicalTrials.gov Identifier: NCT01668953|
Recruitment Status : Active, not recruiting
First Posted : August 20, 2012
Last Update Posted : April 13, 2022
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"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.
|Condition or disease||Intervention/treatment||Phase|
|Lateral Epicondylitis (Tennis Elbow)||Other: Platelet Rich Plasma (PRP) Injection Other: Whole Blood Injection Other: Dry Needle Fenestration Other: Sham Injection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Impact of Platelet Rich Plasma Over Alternative Therapies in Patients With Lateral Epicondylitis|
|Study Start Date :||August 2012|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
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
- 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).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- Acute symptom onset (less than 2 months).
- History of acute elbow trauma (less than one week).
- History of rheumatoid arthritis.
- History of malignancy.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01668953
|United States, Michigan|
|University of Michigan|
|Ann Arbor, Michigan, United States, 48109-5326|
|Hamilton General Hospital|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Mary M Chiavaras, MD, PhD||McMaster University|
|Responsible Party:||McMaster University|
|Other Study ID Numbers:||
Research Seed Grant # 1204 ( Other Grant/Funding Number: Radiological Society of North America (RSNA) )
|First Posted:||August 20, 2012 Key Record Dates|
|Last Update Posted:||April 13, 2022|
|Last Verified:||April 2022|
Platelet Rich Plasma
Wounds and Injuries