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Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment (TBA)
This study has been completed.
Sponsor:
University Hospital, Bordeaux
Collaborator:
Ipsen
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00437762
First received: February 19, 2007
Last updated: February 27, 2013
Last verified: February 2013
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Purpose
Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
| Condition | Intervention | Phase |
|---|---|---|
| Tennis Elbow | Drug: Botulinum Toxin A Injection Drug: Placebo injection | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo |
Resource links provided by NLM:
Further study details as provided by University Hospital, Bordeaux:
Primary Outcome Measures:
- Principal criteria of assessment is pain intensity three months after injection. [ Time Frame: at 3 month ]
Secondary Outcome Measures:
- pain intensity [ Time Frame: to day 30, 90,180, 365 ]
- Number of painful days [ Time Frame: to day 30, 90,180, 365 ]
- Number of associated treatments. [ Time Frame: to day 30, 90,180, 365 ]
- Free pain grip strength [ Time Frame: to day 30, 90,180, 365 ]
- Rate of recidivism after initial relief [ Time Frame: to day 30, 90,180, 365 ]
| Enrollment: | 61 |
| Study Start Date: | April 2007 |
| Study Completion Date: | June 2012 |
| Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Botulinum Toxin A Injection
|
Drug: Botulinum Toxin A Injection
Botulinum Toxin A Injection
|
|
Placebo Comparator: 2
Placebo injection
|
Drug: Placebo injection
Placebo Injection
|
Detailed Description:
- Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
- 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
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Tennis elbow during more than 6 months
- Signature of consent
Exclusion Criteria:
- Less than 18 years old
- Osteoarthritis elbow
- Referred cervical pain
- Fibromyalgia
- Pregnancy
- Myasthenia
- Polymyositis
- SLA
- Anticoagulant treatment
- Aminosides
- Diabetes
- Alcoholism
- Previous botulinum toxin A injections
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00437762
Please refer to this study by its ClinicalTrials.gov identifier: NCT00437762
Locations
| France | |
| Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2. | |
| Bordeaux cedex, France, 330076 | |
Sponsors and Collaborators
University Hospital, Bordeaux
Ipsen
Investigators
| Principal Investigator: | Mathieu DE SEZE, MD | University Hospital, Bordeaux |
More Information
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT00437762 History of Changes |
| Other Study ID Numbers: |
CHUBX 2005/08 |
| Study First Received: | February 19, 2007 |
| Last Updated: | February 27, 2013 |
Keywords provided by University Hospital, Bordeaux:
|
Lateral epicondylitis, tennis elbow, treatment |
Additional relevant MeSH terms:
|
Tennis Elbow Musculoskeletal Diseases Arm Injuries Wounds and Injuries Botulinum Toxins Botulinum Toxins, Type A abobotulinumtoxinA onabotulinumtoxinA |
Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Neuromuscular Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on July 21, 2017