Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment (TBA)
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ClinicalTrials.gov Identifier: NCT00437762 |
Recruitment Status :
Completed
First Posted : February 21, 2007
Last Update Posted : February 28, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tennis Elbow | Drug: Botulinum Toxin A Injection Drug: Placebo injection | Phase 3 |
- 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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (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 |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | June 2012 |
Actual Study Completion Date : | June 2012 |

Arm | Intervention/treatment |
---|---|
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 |
- Principal criteria of assessment is pain intensity three months after injection. [ Time Frame: at 3 month ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00437762
France | |
Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2. | |
Bordeaux cedex, France, 330076 |
Principal Investigator: | Mathieu DE SEZE, MD | University Hospital, Bordeaux |
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT00437762 |
Other Study ID Numbers: |
CHUBX 2005/08 |
First Posted: | February 21, 2007 Key Record Dates |
Last Update Posted: | February 28, 2013 |
Last Verified: | February 2013 |
Lateral epicondylitis, tennis elbow, treatment |
Tennis Elbow Elbow Tendinopathy Tendinopathy Muscular Diseases Musculoskeletal Diseases Arm Injuries Wounds and Injuries Tendon Injuries Botulinum Toxins Botulinum Toxins, Type A |
abobotulinumtoxinA 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 |