A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis

Study Overview
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Brief Summary
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The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months. As secondary objectives, the study aims to demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities. evaluate tolerance of treatment by grip strength measurement and adverse event collection.

Detailed Description
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This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis. All patients will be randomized in 3 following parallel treatment groups: Group A : botulinum toxin + corticoid Group C : placebo of toxin + corticoid Group T : botulinum toxin + placebo corticoid The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.

Official Title
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A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis

Conditions
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Epicondylitis

Intervention / Treatment
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* Drug: Injection, botulinum toxin + corticoid
* Drug: Injection, placebo of toxin + corticoid
* Drug: Injection, botulinum toxin + placebo corticoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged between 18 and 60 years; Physical disability or not; Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os; Signed consent obtained; Covered by health insurance. Exclusion Criteria: Central nervous system disorders result in spasticity in epicondylitis limb; History of severe psychiatric disorder; History of myasthenia gravis; Pregnant or breastfeeding woman; Unable to understand or respond to questions; Contraindication to botulinum toxin or corticoid; Treatment with botulinum toxin 3 months prior to baseline; Anticoagulant theraphy; Difficult to follow-up in the study; Patient under guardianship, or deprived of liberty by a judicial order.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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
Interventional Model Description: Ratio 1:1:1
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A : Association (botulinum toxin + corticoid)<br> | Drug: Injection, botulinum toxin + corticoid<br>* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)<br>|
| Placebo Comparator: Group C : placebo of toxin + corticoid :<br> | Drug: Injection, placebo of toxin + corticoid<br>* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)<br>|
| Active Comparator: Group T : botulinum toxin + placebo corticoid<br> | Drug: Injection, botulinum toxin + placebo corticoid<br>* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of pain intensity between injection of treatment and 6 months after injection | Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS). | At the moment of injection | 
| Variation of pain intensity between injection of treatment and 6 months after injection | Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS. | 6 months after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous pain intensity at rest | Evaluate pain intensity at rest with the VAS. | Before injection, 3 months after injection and 6 months after injection | 
| Pain intensity of motion of wrist flexion | Evaluate pain intensity of motion of wrist flexion with the VAS. | Before injection, 3 months after injection and 6 months after injection | 
| Pain intensity at proximal insertion palpation on epicondylitis muscle | Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control. | Before injection, 3 months after injection and 6 months after injection | 
| Number of days of sick leave | Number of days of sick leave will be noted and collected | 6 months after injection | 
| The percentage of patients returning to professional activity or sportive activity |  | 6 months after injection | 
| Measurement of prehensile grasp capabilities by a force | The force will be measured by Jamar Hydraulic hand dynamometer. | At baseline, 3 months after injection, 6 months after injection | 
| Functional outcome after injection | Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation | At baseline, 3 months after injection, 6 months after injection | 
| Anxiety and depression tests | Hospital Anxiety and Depression scale will be used | At baseline, 3 months after injection, 6 months after injection | 
| Frequence and gravity of adverse events | Adverse events will be collected and their severity will be reported. | At baseline, 3 months after injection, 6 months after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epicondylitis, Botulinum toxin, Corticoid