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Treatment of Tennis Elbow With Botulinum Toxin

This study has been completed.
Sponsor:
Collaborator:
New World Development Company Limited
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00119704
First received: July 6, 2005
Last updated: May 8, 2006
Last verified: June 2005

July 6, 2005
May 8, 2006
September 2002
Not Provided
100 mm visual analog scale (VAS)
Same as current
Complete list of historical versions of study NCT00119704 on ClinicalTrials.gov Archive Site
Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
Same as current
Not Provided
Not Provided
 
Treatment of Tennis Elbow With Botulinum Toxin
Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial

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

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Epicondylitis, Lateral Humeral
Drug: Botulinum toxin A injection or normal saline
Not Provided
Wong SM, Hui AC, Tong PY, Poon DW, Yu E, Wong LK. Treatment of lateral epicondylitis with botulinum toxin: a randomized, double-blind, placebo-controlled trial. Ann Intern Med. 2005 Dec 6;143(11):793-7. Summary for patients in: Ann Intern Med. 2005 Dec 6;143(11):I48.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
March 2005
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00119704
CRE-2002.354-T
Not Provided
Not Provided
Chinese University of Hong Kong
New World Development Company Limited
Principal Investigator: Andrew CF Hui, MRCP Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
Chinese University of Hong Kong
June 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP