Clinical Trial: Treatment of Tennis Elbow with Botulinum Toxin

This study has been completed.

Sponsors and Collaborators: Chinese University of Hong Kong
New World Development 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

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: 
Primary Outcomes: 100 mm visual analog scale (VAS)
Secondary Outcomes: Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
Expected Total Enrollment:  60

Study start: September 2002;  Study completion: June 2005
Last follow-up: March 2005;  Data entry closure: April 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 above,  Genders Eligible for Study:  Both
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

Location Information


Hong Kong
      North District Hospital, Sheung Shui, New Territories,  Hong Kong

      Prince of Wales Hospital, Shatin, New Territories,  Hong Kong

Study chairs or principal investigators

Andrew CF Hui, MRCP,  Principal Investigator,  Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong   

More Information

Study ID Numbers:  CRE-2002.354-T
Last Updated:  August 1, 2005
Record first received:  July 14, 2005
ClinicalTrials.gov Identifier:  NCT00119704
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
ClinicalTrials.gov processed this record on 2005-08-02



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