Treatment of Tennis Elbow with Botulinum Toxin - Article
Clinical Trial: Treatment of Tennis Elbow with Botulinum Toxin
This study has been completed.
|Epicondylitis, Lateral Humeral || Drug: Botulinum toxin A injection or normal saline ||Phase III |
MedlinePlus related topics: Elbow Injuries and Disorders
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
Secondary Outcomes: Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
Expected Total Enrollment: 60
Study start: September 2002; Study completion: June 2005
Last follow-up: March 2005; Data entry closure: April 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.
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.
- Patients aged 18 years and up
- Pain at the lateral side of the elbow
- Pain at the lateral epicondyle during resisted dorsiflexion of the wrist with the elbow in full extension
- Pain for longer than 3 months
North District Hospital, Sheung Shui, New Territories, Hong Kong
Prince of Wales Hospital, Shatin, New Territories, Hong Kong
Andrew CF Hui, MRCP, Principal Investigator, Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
Last Updated: August 1, 2005
Record first received: July 14, 2005
ClinicalTrials.gov Identifier: NCT00119704
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-02