Status:
COMPLETED
Hyaluronate Injection for Lateral Epicondylitis
Lead Sponsor:
Shaare Zedek Medical Center
Conditions:
Tennis Elbow
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
This proposal is a prospective, randomized, double-blinded study to evaluate the efficacy of hyaluronic acid (HA) injections for chronic lateral epicondylitis (LE). HA has traditionally been used to t...
Detailed Description
Patients will be randomized and blinded into one of the two arms. Patients will receive 3 injections total spaced over a 4 week period. After the injections are completed, patients will return for eva...
Eligibility Criteria
Inclusion
- Included will be patients older than 18 years with lateral epicondylitis. The criteria for diagnosis will include pain and tenderness at the lateral epicondyle worse with resisted wrist or finger extension (with the elbow in the extended position).
Exclusion
- Excluded will be patients with history of prior elbow surgery, history of fracture or dislocation, known inflammatory or autoimmune disorders, or known hypersensitivity to HA.
- Exclusion will also include a known allergy to birds, feathers or egg products. If the patient has complaints of pain or tenderness on exam in the area of the radial neck, then a component of radial tunnel syndrome will be assumed and these patients will be excluded from study.
- Patients that are pregnant will be excluded.
- Patients with medial epicondylitis
- Prior elbow surgery
- Elbow steroid injection in the past 3 months
- Inflammatory condition, like rheumatoid arthritis or lupus
Key Trial Info
Start Date :
January 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT02258295
Start Date
January 18 2017
End Date
September 1 2019
Last Update
April 24 2020
Active Locations (1)
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1
Shaare Zedek Medical Center
Jerusalem, Israel, 91031