EPITOX: A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Study Details
Study Description
Brief Summary
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
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demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
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evaluate tolerance of treatment by grip strength measurement and adverse event collection.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Group A : Association (botulinum toxin + corticoid)
|
Drug: Injection, botulinum toxin + corticoid
Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
|
| Placebo Comparator: Group C : placebo of toxin + corticoid :
|
Drug: Injection, placebo of toxin + corticoid
Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
|
| Active Comparator: Group T : botulinum toxin + placebo corticoid
|
Drug: Injection, botulinum toxin + placebo corticoid
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 %)
|
Outcome Measures
Primary Outcome Measures
- Variation of pain intensity between injection of treatment and 6 months after injection [At the moment of 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).
- Variation of pain intensity between injection of treatment and 6 months after injection [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.
Secondary Outcome Measures
- Spontaneous pain intensity at rest [Before injection, 3 months after injection and 6 months after injection]
Evaluate pain intensity at rest with the VAS.
- Pain intensity of motion of wrist flexion [Before injection, 3 months after injection and 6 months after injection]
Evaluate pain intensity of motion of wrist flexion with the VAS.
- Pain intensity at proximal insertion palpation on epicondylitis muscle [Before injection, 3 months after injection and 6 months after injection]
Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control.
- Number of days of sick leave [6 months after injection]
Number of days of sick leave will be noted and collected
- The percentage of patients returning to professional activity or sportive activity [6 months after injection]
- Measurement of prehensile grasp capabilities by a force [At baseline, 3 months after injection, 6 months after injection]
The force will be measured by Jamar Hydraulic hand dynamometer.
- Functional outcome after injection [At baseline, 3 months after injection, 6 months after injection]
Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation
- Anxiety and depression tests [At baseline, 3 months after injection, 6 months after injection]
Hospital Anxiety and Depression scale will be used
- Frequence and gravity of adverse events [At baseline, 3 months after injection, 6 months after injection]
Adverse events will be collected and their severity will be reported.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient aged between 18 and 60 years;
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Physical disability or not;
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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;
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Signed consent obtained;
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Covered by health insurance.
Exclusion Criteria:
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Central nervous system disorders result in spasticity in epicondylitis limb;
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History of severe psychiatric disorder;
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History of myasthenia gravis;
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Pregnant or breastfeeding woman;
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Unable to understand or respond to questions;
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Contraindication to botulinum toxin or corticoid;
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Treatment with botulinum toxin 3 months prior to baseline;
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Anticoagulant theraphy;
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Difficult to follow-up in the study;
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Patient under guardianship, or deprived of liberty by a judicial order.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré | Garches | Hauts-de-Seine | France | 92380 |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Study Chair: François Genêt, MD, PhD, Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P160926J
- 2017-001709-33