Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Tennis Elbow

Intervention / Treatment
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* Drug: Botulinum Toxin A Injection
* Drug: Placebo injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Botulinum Toxin A Injection | Drug: Botulinum Toxin A Injection<br>* Botulinum Toxin A Injection<br>|
| Placebo Comparator: 2<br>Placebo injection | Drug: Placebo injection<br>* Placebo Injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Principal criteria of assessment is pain intensity three months after injection. |  | at 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity |  | to day 30, 90,180, 365 | 
| Number of painful days |  | to day 30, 90,180, 365 | 
| Number of associated treatments. |  | to day 30, 90,180, 365 | 
| Free pain grip strength |  | to day 30, 90,180, 365 | 
| Rate of recidivism after initial relief |  | to day 30, 90,180, 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lateral epicondylitis, tennis elbow, treatment