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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
Sponsor:
Collaborator:
New World Development Company Limited
Information provided by:
Chinese University of Hong Kong

Study Description
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Brief Summary:
The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).

Condition or disease Intervention/treatment Phase
Epicondylitis, Lateral Humeral Drug: Botulinum toxin A injection or normal saline Phase 3

Detailed Description:

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 Design
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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

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 100 mm visual analog scale (VAS)

Secondary Outcome Measures :
  1. Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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


Locations
Hong Kong
Prince of Wales Hospital
Shatin, New Territories, Hong Kong
North District Hospital
Sheung Shui, New Territories, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
New World Development Company Limited
Investigators
Principal Investigator: Andrew CF Hui, MRCP Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
More Information
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Publications of Results:

ClinicalTrials.gov Identifier: NCT00119704     History of Changes
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

Additional relevant MeSH terms:
Tennis Elbow
Elbow Tendinopathy
Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries
Botulinum Toxins
Botulinum Toxins, Type A
 onabotulinumtoxinA
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