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
Conditions
Interventions
Trade Name: Xeomin
Product Name: Xeomin
Pharmaceutical Form: Powder for injection
INN or Proposed INN: Neurotoxine de Clostridium botulinum de type A, s
Sponsors
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.; Secondary Objective: - To show an improvement in the quality of life for the patients and an early resumption of sporting or professional activity. - To evaluate the tolerance of the treatment by measuring the gripping force and collecting the adverse effects that may be encountered. ;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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Intensity of pain (measured by VAS), before injection, at 3 months and at 6 months after injection: - spontaneous at rest; - during flexion of the wrist; - during palpation of the proximal insertion of the muscles responsible for epicondylitis. - Number of days off work within the 6 months after the injection, and the date of resumption of the professional or sporting activity; - Proportion of patients who resumed their professional or sporting activity at 6 months after the injection; - Gripping force, measured with a Jamar Hand Hydraulic Dynamometer, evaluated at inclusion and then at 3 months and 6 months after injection; - Functional repercussion of the epicondylitis: "Patient Rated Tennis Elbow Assessment Evaluation" questionnaire before injection, then at 3 months and 6 months after injection; - Hospital Anxiety and Depression scale; - Frequency and severity of the adverse effects. ;Timepoint(s) of evaluation of this end point: 3 months and 6 months | — |
Countries
France
Contacts
Public ContactDRCI Hôpital St Louis
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
Outcome results
None listed