Lateral Epicondylitis (Tennis Elbow)
Conditions
Keywords
common extensor, lateral epicondyle, tennis elbow
Brief summary
This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy.
Detailed description
This is a randomized control trial comparing the use of leukocyte rich platelet rich plasma injections to percutaneous tenotomy for the treatment of chronic common extensor tendinopathy. Patients with a history of common extensor tendinopathy for greater than 3 months, refractory to conservative treatments, are randomized into one of two groups: injection with leukocyte rich platelet rich plasma or percutaneous tenotomy with the Tenex system. Both groups of patients are followed up in clinic at 1 week, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year following the procedure to examine levels of pain or complications following both procedures.
Interventions
BIOLOGICALLeukocyte rich platelet rich plasma
Leukocyte rich platelet rich plasma will be obtained and prepared from a peripheral artery of the subject and then will be injected in the common extensor tendon
DEVICEPercutaneous Tenotomy
Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-blinded, parallel randomized control trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes
Inclusion criteria
* At least 3 months of lateral elbow pain * Subjectively failed trial of physical therapy and counterbracing * Identifiable pathology on ultrasound (one or more of the following: thickened or disorganized tendon origin, microtearing, edema, neovascularization
Exclusion criteria
* Steroid injection within the last 3 months * Previous surgery for common extensor tendinopathy * Current treatment with analgesics * Pregnant, non-English speaking, or illiterate individuals * History of anemia * History of bleeding disorder * Anticoagulant use * History of cervical radiculopathy * Hemoglobin less than 11 grams per deciliter * Hematocrit less than 33% * Platelet count outside of normal range of 150-400 x 1000 microliter
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain: visual analogue scale | up to 12 months post-procedure | Change in pain will be measured using a 10 point visual analogue scale where 0 represents no pain and 10 indicates the worst pain possible. |
| Change in function | up to 12 months post-procedure | Change in function will be measured using the Oxford Elbow score using a 48 point scale where a score of 0 indicates severe functional impairment and a score of 48 indicates no functional impairment |
Countries
United States
Outcome results
None listed