Treatment of Tennis Elbow With Botulinum Toxin
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Purpose
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial |
- 100 mm visual analog scale (VAS)
- Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Previous operations (including previous steroid injections for the disorder)
- Nerve entrapment
- Pregnancy and while breast-feeding
- Presence of systemic neuromuscular disorders such as myasthenia gravis
Contacts and Locations| Hong Kong | |
| Prince of Wales Hospital | |
| Shatin, New Territories, Hong Kong | |
| North District Hospital | |
| Sheung Shui, New Territories, Hong Kong | |
| Principal Investigator: | Andrew CF Hui, MRCP | Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00119704 History of Changes |
| Other Study ID Numbers: | CRE-2002.354-T |
| Study First Received: | July 6, 2005 |
| Last Updated: | May 8, 2006 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Additional relevant MeSH terms:
|
Tennis Elbow Musculoskeletal Diseases Arm Injuries Wounds and Injuries Botulinum Toxins, Type A Botulinum Toxins Neuromuscular Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013