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Sponsors and Collaborators: |
Chinese University of Hong Kong New World Development Company Limited |
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Information provided by: | Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT00119704 |
The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).
Condition | Intervention | Phase |
---|---|---|
Epicondylitis, Lateral Humeral |
Drug: Botulinum toxin A injection or normal saline |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial |
Estimated Enrollment: | 60 |
Study Start Date: | September 2002 |
Estimated Study Completion Date: | March 2005 |
Tennis elbow (lateral epicondylitis) is a common cause of chronic elbow pain and wrist extensor dysfunction in adults, affecting 1% to 3% of the general population per year.
There is currently no consensus on its optimal treatment with wide-ranging options available. The best available scientific evidence suggests that only topical non-steroidal anti-inflammatory drugs and possibly, oral non-steroidal anti-inflammatory drugs may be useful for short term pain relief, while corticosteroid injections presented both benefits and harms as a short term measure.
Botulinum toxin has been reported in the treatment of lateral epicondylitis with promising results but these studies lack a control group bringing up the question whether recovery was a result of intervention or the natural history of the disease.
Method:
A twin-center, prospective, randomized, double-blind, placebo-controlled trial in which all patients received either a botulinum injection or a placebo saline injection.
Consecutive patients over 18 years old with tennis elbow referred to the outpatient clinic at the investigators’ institution will be screened for this study. Eligible patients will be invited to participate in the study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Hong Kong | |
North District Hospital | |
Sheung Shui, New Territories, Hong Kong | |
Prince of Wales Hospital | |
Shatin, New Territories, Hong Kong |
Principal Investigator: | Andrew CF Hui, MRCP | Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong |
Study ID Numbers: | CRE-2002.354-T |
Study First Received: | July 6, 2005 |
Last Updated: | May 8, 2006 |
ClinicalTrials.gov Identifier: | NCT00119704 History of Changes |
Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Botulinum Toxins Musculoskeletal Diseases Tennis Elbow |
Wounds and Injuries Disorders of Environmental Origin Arm Injuries |
Botulinum Toxins Musculoskeletal Diseases Tennis Elbow Anti-Dyskinesia Agents Therapeutic Uses |
Wounds and Injuries Disorders of Environmental Origin Central Nervous System Agents Pharmacologic Actions Arm Injuries |