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

NCT ID: NCT03380559

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-19
• Study Completion Date: 2021-08-19

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.

Conditions

Epicondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Group A : Association (botulinum toxin + corticoid)

Group Type: EXPERIMENTAL

Injection, botulinum toxin + corticoid

Intervention Type: DRUG

• Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
• Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)

Group C : placebo of toxin + corticoid :

Group Type: PLACEBO_COMPARATOR

Injection, placebo of toxin + corticoid

Intervention Type: DRUG

• Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
• Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)

Group T : botulinum toxin + placebo corticoid

Group Type: ACTIVE_COMPARATOR

Injection, botulinum toxin + placebo corticoid

Intervention Type: DRUG

• 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 %)

Interventions

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 %)

Intervention Type: 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 %)

Intervention Type: 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 %)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François Genêt, MD, PhD

Role: STUDY_CHAIR

Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré

Locations

Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré

Garches, Hauts-de-Seine, France

Countries

France

Other Identifiers

2017-001709-33

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P160926J

Identifier Type: -

Identifier Source: org_study_id