Treatment of Tennis Elbow With Botulinum Toxin
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ClinicalTrials.gov Identifier: NCT00119704 |
Recruitment Status :
Completed
First Posted : July 14, 2005
Last Update Posted : May 9, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Epicondylitis, Lateral Humeral | Drug: Botulinum toxin A injection or normal saline | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial |
Study Start Date : | September 2002 |
Study Completion Date : | March 2005 |

- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00119704
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 |
ClinicalTrials.gov Identifier: | NCT00119704 |
Other Study ID Numbers: |
CRE-2002.354-T |
First Posted: | July 14, 2005 Key Record Dates |
Last Update Posted: | May 9, 2006 |
Last Verified: | June 2005 |
Tennis Elbow Elbow Tendinopathy Tendinopathy Muscular Diseases Musculoskeletal Diseases Arm Injuries Wounds and Injuries Tendon Injuries Botulinum Toxins Botulinum Toxins, Type A |
abobotulinumtoxinA Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |