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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Botulinum Toxins

Criteria

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.