Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2002-09-30
2005-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Botulinum toxin A injection or normal saline
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Nerve entrapment
* Pregnancy and while breast-feeding
* Presence of systemic neuromuscular disorders such as myasthenia gravis
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
New World Development Company Limited
INDUSTRY
Chinese University of Hong Kong
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew CF Hui, MRCP
Role: PRINCIPAL_INVESTIGATOR
Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prince of Wales Hospital
Shatin, New Territories, , Hong Kong
North District Hospital
Sheung Shui, New Territories, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CRE-2002.354-T
Identifier Type: -
Identifier Source: org_study_id