Clinical trial NCT03380559: A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Official title: A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epicondylitis
Keywords: Epicondylitis
Botulinum toxin
Corticoid
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Ratio 1:1:1
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Variation of pain intensity between injection of treatment and 6 months after injection
timeFrame: At the moment of injection
measure: Variation of pain intensity between injection of treatment and 6 months after injection
timeFrame: 6 months after injection
Secondary outcomes:
measure: Spontaneous pain intensity at rest
timeFrame: Before injection, 3 months after injection and 6 months after injection
measure: Pain intensity of motion of wrist flexion
timeFrame: Before injection, 3 months after injection and 6 months after injection
measure: Pain intensity at proximal insertion palpation on epicondylitis muscle
timeFrame: Before injection, 3 months after injection and 6 months after injection
measure: Number of days of sick leave
timeFrame: 6 months after injection
measure: The percentage of patients returning to professional activity or sportive activity
timeFrame: 6 months after injection
measure: Measurement of prehensile grasp capabilities by a force
timeFrame: At baseline, 3 months after injection, 6 months after injection
measure: Functional outcome after injection
timeFrame: At baseline, 3 months after injection, 6 months after injection
measure: Anxiety and depression tests
timeFrame: At baseline, 3 months after injection, 6 months after injection
measure: Frequence and gravity of adverse events
timeFrame: At baseline, 3 months after injection, 6 months after injection
Other outcomes:
Locations:
city: Garches
country: France
facility: Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré
state: Hauts-de-Seine
Study officials:
affiliation: Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré
name: François Genêt, MD, PhD
role: STUDY_CHAIR
References: