- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00119704
Treatment of Tennis Elbow With Botulinum Toxin
Treatment of Lateral Epicondylitis With Botulinum Toxin: A Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Shatin, New Territories, Hong Kong
- Prince of Wales Hospital
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Sheung Shui, New Territories, Hong Kong
- North District Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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100 mm visual analog scale (VAS)
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Secondary Outcome Measures
Outcome Measure |
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Grip strength measured with a Jamar Hydraulic Hand Dynamometer with the elbow fully extended and the hand in middle position.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew CF Hui, MRCP, Department of Medicine & Therapeutics, Facutly of Medicine, The Chinese University of Hong Kong
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Wounds and Injuries
- Musculoskeletal Diseases
- Muscular Diseases
- Tendon Injuries
- Tendinopathy
- Arm Injuries
- Elbow Tendinopathy
- Tennis Elbow
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Cholinergic Agents
- Membrane Transport Modulators
- Acetylcholine Release Inhibitors
- Neuromuscular Agents
- Botulinum Toxins
- Botulinum Toxins, Type A
- abobotulinumtoxinA
Other Study ID Numbers
- CRE-2002.354-T
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epicondylitis, Lateral Humeral
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Hospital for Special Surgery, New YorkActive, not recruitingLateral Epicondylitis | Lateral Epicondylitis, Unspecified Elbow | Lateral Epicondylitis, Left Elbow | Lateral Epicondylitis, Right Elbow | Lateral Epicondylitis (Tennis Elbow) Bilateral | Medial Epicondylitis | Medial Epicondylitis, Right Elbow | Medial Epicondylitis, Left ElbowUnited States
-
Bispebjerg HospitalCompleted
-
Dojode, Chetan M., MBBS, MSCompletedTennis Elbow | Epicondylitis, Lateral HumeralIndia
-
Centre Hospitalier Universitaire de NīmesTerminatedTennis Elbow | Epicondylitis, Lateral HumeralFrance
-
Seinajoki Central HospitalCompletedTennis Elbow | Epicondylitis, Lateral HumeralFinland
-
Karolinska InstitutetRehband SwedenCompletedTennis Elbow | Epicondylitis, Lateral HumeralSweden
-
University of OsloAllmennmedisinsk forskningsfond, NorwayCompletedTennis Elbow | Epicondylitis, Lateral HumeralNorway
-
Universidad Católica de ÁvilaActive, not recruitingHumeral Epicondylitis, LateralSpain
-
Centre Hospitalier Universitaire de NīmesCompletedTennis Elbow | Epicondylitis, Lateral HumeralFrance
-
MiMedx Group, Inc.TerminatedEpicondylitis, Lateral HumeralUnited States
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