A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
- Conditions
- Epicondylitis
- Interventions
- Drug: Injection, botulinum toxin + corticoidDrug: Injection, placebo of toxin + corticoidDrug: Injection, botulinum toxin + placebo corticoid
- Registration Number
- NCT03380559
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- 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
* 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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 33
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A : Association (botulinum toxin + corticoid) Injection, botulinum toxin + corticoid - Group C : placebo of toxin + corticoid : Injection, placebo of toxin + corticoid - Group T : botulinum toxin + placebo corticoid Injection, botulinum toxin + placebo corticoid -
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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.
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 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.
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
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.
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.
Anxiety and depression tests At baseline, 3 months after injection, 6 months after injection Hospital Anxiety and Depression scale will be used
Trial Locations
- Locations (1)
Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré
🇫🇷Garches, Hauts-de-Seine, France