Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment
NCT ID: NCT00437762
Last Updated: 2013-02-28
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
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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2007-04-30
2012-06-30
Brief Summary
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Detailed Description
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* Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
* Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
* Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
* Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
* Study plan: randomized parallel groups
* Number of subjects : 60
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
Botulinum Toxin A Injection
Botulinum Toxin A Injection
Botulinum Toxin A Injection
2
Placebo injection
Placebo injection
Placebo Injection
Interventions
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Botulinum Toxin A Injection
Botulinum Toxin A Injection
Placebo injection
Placebo Injection
Eligibility Criteria
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Inclusion Criteria
* Signature of consent
Exclusion Criteria
* Osteoarthritis elbow
* Referred cervical pain
* Fibromyalgia
* Pregnancy
* Myasthenia
* Polymyositis
* SLA
* Anticoagulant treatment
* Aminosides
* Diabetes
* Alcoholism
* Previous botulinum toxin A injections
18 Years
ALL
No
Sponsors
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Ipsen
INDUSTRY
University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Mathieu DE SEZE, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Bordeaux
Locations
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Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.
Bordeaux, , France
Countries
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Other Identifiers
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CHUBX 2005/08
Identifier Type: -
Identifier Source: org_study_id
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