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

Epicondylitis Clinical Trial

— EPITOX  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380559
• Other study ID #: P160926J
• Secondary ID: 2017-001709-33
• Status: Completed
• Phase: Phase 3
• Start date: April 19, 2019
• Est. completion date: August 19, 2021

Study information

• Verified date: September 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: August 19, 2021
• Est. primary completion date: July 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epicondylitis
• Tennis Elbow

Intervention

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 %)
• 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 %)
• 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 %)

Locations

Country	Name	City	State
France	Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré	Garches	Hauts-de-Seine

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Spontaneous pain intensity at rest	Evaluate pain intensity at rest with the VAS.	Before injection, 3 months after injection and 6 months after injection
Secondary	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
Secondary	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
Secondary	Number of days of sick leave	Number of days of sick leave will be noted and collected	6 months after injection
Secondary	The percentage of patients returning to professional activity or sportive activity		6 months after injection
Secondary	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
Secondary	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
Secondary	Anxiety and depression tests	Hospital Anxiety and Depression scale will be used	At baseline, 3 months after injection, 6 months after injection
Secondary	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