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Treatment of Tennis Elbow With Botulinum Toxin
This study has been completed.
First Received: July 6, 2005   Last Updated: May 8, 2006   History of Changes
Sponsors and Collaborators: Chinese University of Hong Kong
New World Development Company Limited
Information provided by: Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00119704
  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 III

MedlinePlus related topics: Elbow Injuries and Disorders
Drug Information available for: Botulinum toxin A Clostridium botulinum toxin
U.S. FDA Resources
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

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 100 mm visual analog scale (VAS)

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00119704

Locations
Hong Kong
North District Hospital
Sheung Shui, New Territories, Hong Kong
Prince of Wales Hospital
Shatin, 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

Publications:
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

Study placed in the following topic categories:
Botulinum Toxins
Musculoskeletal Diseases
Tennis Elbow
Wounds and Injuries
Disorders of Environmental Origin
Arm Injuries

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 07, 2009