A

Phase 1

• Conditions: Patients suffering from unilateral lateral epicondylitis, persistent for more than 3 months or recurrent and not having responded to at least one reference treatment; MedDRA version: 20.0 Level: PT Classification code 10014971 Term: Epicondylitis System Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-001709-33-FR
• Lead Sponsor: ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-05
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

1) Males or females aged from 18 to 60 years;
2) Whether or not having a professional activity;
3) Whether or not having a motor disability;
4) Unilateral lateral epicondylitis, persistent for more than 3 months, or recurrent and not having responded to at least one reference treatment: local injection of corticosteroids, physical therapy, rest, or NSAIDs;
5) Signing of an informed consent form;
6) Affiliation to a health insurance organism.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Central nervous system disorder, which is responsible for spasticity in the limb suffering from epicondylitis;
2) History of severe psychiatric disorder;
3) History of myasthenia gravis;
4) Pregnant or nursing women;
5) Inability to understand or to answer questions;
6) Contra-indication to botulinum toxin or corticosteroids;
7) Injection of botulinum toxin within 3 months prior to inclusion;
8) Taking any anticoagulant drugs;
9) Predictable difficulties of follow-up;
10) Patient under guardianship or curatorship.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that the intramuscular injection of botulinum toxin at paralytic doses coupled with a local injection of corticosteroids is more effective (i) than the injection of corticosteroids alone and (ii) than the injection of botulinum toxin alone, to reduce pain at 6 months, in patients with lateral epicondylitis.;<br> Secondary Objective: - To show an improvement in the quality of life for the patients and an early resumption of sporting or professional activity.<br> - To evaluate the tolerance of the treatment by measuring the gripping force and collecting the adverse effects that may be encountered.<br> ;Primary end point(s): Variation between the injection and 6 months after the injection, of the intensity of pain during the contraction of the extensor muscles of the wrist, measured by a VAS (Visual Analogue Scale).;Timepoint(s) of evaluation of this end point: 6 months