Dysport® Injection in the Treatment of Chronic Lateral Epicondylitis

Study Overview
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Brief Summary
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The purpose of this study is to determine whether a single injection of Dysport with a new protocol at forearm is effective in the management of chronic lateral epicondylitis.

Detailed Description
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Some studies valued the effectiveness of botulinum toxin. There is a great amount of controversy on the amount of botulinum toxin injected and the location of the injection. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo at a new injection site at the forearm in the treatment of chronic tennis elbow unrelieved by corticosteroid injection and physiotherapy. It is a double blind randomized controlled trial.

Conditions
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Tennis Elbow

Intervention / Treatment
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* Drug: NaCl 0.9%
* Drug: Botulinum Toxin A


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain: pain will be assessed as the physician touches lateral epicondyle or passively flexing the patient's wrist and while the patient extends his/her wrist or 3rd finger against resistance. Individuals who fulfill two or more of above will be considered to have lateral epicondylitis. Symptom duration: should be at least 6 months. Previous trial of complete course of physiotherapy and corticosteroid injection. Exclusion Criteria: Rheumatoid arthritis Generalized polyarthritis Local elbow arthritis Simultaneous medial epicondylalgia Bilateral lateral epicondylitis Neurologic deficits (abnormal light touch sensation, deep tendon reflexes abnormality, radicular pain, radial nerve entrapment, signs of nerve root compression, decreased muscle force, multiple sclerosis, seizures) The use of corticosteroid in last 30 days Simultaneous use of drugs other than acetaminophen or physical therapy in the course of study Pregnancy Breast-feeding Previous hand surgery Having a hobby or job that needs finger extension

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: A<br> | Drug: Botulinum Toxin A<br> <br> * Other names: Dysport;|
| Placebo Comparator: B<br> | Drug: NaCl 0.9%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score on VAS at maximal grip, at maximal pinch, and during previous month at rest |  | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients subjective feeling of improvement. |  | 4 months | 
| Tenderness on lateral epicondyle |  | 4 months | 
| Pain sensation on resisted wrist extension, and passive wrist flexion |  | 4 months | 
| Pain-free grip strength, and pinch strength |  | 4 months | 
| Maximal grip strength, and pinch strength |  | 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tennis Elbow, Botulinum Toxin