Botulinum toxin and degenerative rotator cuff tendinopathies: a randomized trial »DEROTOX (DEgenerative ROtator cuff disease and botulinum TOXin)

Phase 1

• Conditions: Degenerative tendinopathies of the rotator cuff; MedDRA version: 20.1Level: LLTClassification code 10080130Term: TendinopathySystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2021-003315-25-FR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-18
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

• 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).

Study & Design

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