Degenerative tendinopathies of the rotator cuff MedDRA version: 20.1 Level: LLT Classification code 10080130 Term: Tendinopathy System Organ Class: 100000004859
Conditions
Interventions
Trade Name: XEOMIN 100 units powder for solution for injection
Product Name: XEOMIN
Pharmaceutical Form: Powder for solution for injection
Pharmaceutical form of the placebo: Solution for infusion
Rou
Sponsors
ASSISTANCE PUBLIQUE – HÔPITAUX DE PARIS - Direction de la Recherche Clinique et de l’Innovation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age> 40 years old • Duration of pain> 1 month • Pain intensity = 40/100 on the visual analogue scale • SPADI score = 30/100 • Pain medication (s) unchanged within 30 days of enrollment • Pain with or without weakness during Jobe's maneuver (29) • Ultrasound within 30 days, showing tendinopathy of the supra-spinatus, with or without rupture • Affiliation to a social security scheme • Ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain) • Availability for the visits provided for by the protocol 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • Reduced passive range of motion • Glenohumeral instability • Tendon calcification • Ultrasound showing a concomitant rupture of the infra-spinatus or the subscapularis • Corticosteroid infiltration in the 30 days preceding the inclusion visit • Shoulder surgery • Humeral fracture, inflammatory rheumatism and neoplastic disease • Contraindication to XEOMIN® (hypersensitivity to XEOMIN® or to one of the excipients or to any other botulinum toxin product, generalized disorder of muscle activity, in the event of infection or inflammation at the injection site concerning) • Concomitant use of aminosides, ciclosporin, aminoquinolines • Skin infection at the intended injection site • Participation in another interventional research involving the human person (RIPH) during the 3 months of follow-up of the DEROTOX Research. Participation in another RIPH will be possible beyond these 3 months. • Pregnancy, breastfeeding • Injection of botulinum toxin in the last 6 months • Vulnerable people (under legal protection, guardianship or curatorship).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to evaluate the efficacy of botulinum toxin in the treatment of degenerative tendinopathies of the rotator cuff of the shoulder, at 1 month, on the basis of the Shoulder Pain And Disability Index score ( SPADI) total. ;Secondary Objective: The secondary objective of the study is to evaluate the efficacy of botulinum toxin in the treatment of degenerative tendinopathies of the rotator cuff of the shoulder, on the basis of the total SPADI score at 3 months, sub-scores SPADI pain and function at 3 months, overall improvement perceived at 1 month and 3 months, drug consumption over 3 months of follow-up, and acceptability of treatment at 1 month and 3 months. ;Primary end point(s): The primary endpoint is the total SPADI score at one month. The SPADI is a questionnaire made up of 13 items. The total SPADI includes a pain sub-score and a function sub-score making it possible to rate pain (question 1-5) and functional limitation (question 1-8) (17.4.1) from 0 to 100, where 100 corresponds to the impact on the most important. ;Timepoint(s) of evaluation of this end point: 1 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • The total SPADI score at 3 months, • The SPADI sub-scores (pain and functional limitation) at 3 months, • The overall improvement perceived by EVA (17.4.2) from 0 to 100 at 1 and at 3 months • Analgesic medication from a weekly logbook over the 3-month follow-up • The acceptability of VAS treatment from 0 to 100 at 1 and 3 months. ;Timepoint(s) of evaluation of this end point: 1 and 3 months | — |
Countries
France
Outcome results
None listed