Treatment of Tennis Elbow With Botulinum Toxin
Primary Purpose
Epicondylitis, Lateral Humeral
Status
Completed
Phase
Phase 3
Locations
Hong Kong
Study Type
Interventional
Intervention
Botulinum toxin A injection or normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Epicondylitis, Lateral Humeral
Eligibility 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
Sites / Locations
- Prince of Wales Hospital
- North District Hospital
Outcomes
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.
Full Information
NCT ID
NCT00119704
First Posted
July 6, 2005
Last Updated
May 8, 2006
Sponsor
Chinese University of Hong Kong
Collaborators
New World Development Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT00119704
Brief Title
Treatment of Tennis Elbow With Botulinum Toxin
Official Title
Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
New World Development Company Limited
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether Botulinum A toxin is effective in the treatment of tennis elbow (lateral epicondylitis).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epicondylitis, Lateral Humeral
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A injection or normal saline
Primary Outcome Measure Information:
Title
100 mm visual analog scale (VAS)
Secondary Outcome Measure Information:
Title
Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew CF Hui, MRCP
Organizational Affiliation
Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin, New Territories
Country
Hong Kong
Facility Name
North District Hospital
City
Sheung Shui, New Territories
Country
Hong Kong
12. IPD Sharing Statement
Citations:
PubMed Identifier
16330790
Citation
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. doi: 10.7326/0003-4819-143-11-200512060-00007.
Results Reference
result
Learn more about this trial
Treatment of Tennis Elbow With Botulinum Toxin
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