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
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial

Resource links provided by NLM:


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
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

Publications:
ClinicalTrials.gov Identifier: NCT00119704     History of Changes
Other Study ID Numbers: CRE-2002.354-T
Study First Received: July 6, 2005
Last Updated: May 8, 2006
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Botulinum Toxins, Type A
Botulinum Toxins
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 16, 2014