DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Merz Pharmaceuticals GmbH
• Treatments: incobotulinumtoxinA

Criteria

Inclusion Criteria:

• age > 40 years;

• pain duration > 1 month;

• pain intensity ≥ 40/100 on visual analog scale;

• SPADI ≥ 30/100;

• medication against pain stable at least 30 days before enrolment;

• pain with or without weakness during the Jobe manoeuver;

• ultrasonography within the 30 days, showing tendinopathy of the supra-spinatus, with or without tear;

• affiliation to health insurance Sécurité Sociale;

• ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain);

• availability for the visits planned by the protocol;

• use of an effective method of contraception in women of childbearing potential, started at least 1 month before and lasting for at least 1 month after receiving study treatment.

Exclusion Criteria:

• reduced passive range of motion;

• antero-posterior instability;

• tendinous calcification;

• ultrasonography showing concomitant tear of the infra-spinatus or the subscapularis;

• corticosteroid injection within the previous 30 days;

• previous surgery of the shoulder;

• humeral fracture, inflammatory joint disease and neoplastic disorders;

• contraindication to XEOMIN® (allergy to XEOMIN® or any other botulinum toxin product);

• skin infection at the planned 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;

• concomitant use of aminoglycosides, cyclosporine, aminoquinolines;

• patients with a history of aspiration pneumonia and dysphagia;

• patients on anticoagulant therapy or on therapy that may have an anticoagulant effect.

• Patients with bleeding disorders.

• Patients with amyotrophic lateral sclerosis, myasthenia gravis or, Lambert-Eaton syndrome

• Patients with other conditions causing peripheral neuromuscular dysfunction.

• In target muscles that show pronounced weakness or atrophy.

• Women of childbearing age having a positive urine pregnancy test.

• concomitant use of spectinomycin

• in case of pregnancy, breastfeeding

• injection of botulinum toxin in the last 6 months

• vulnerable people (under legal protection, guardianship or curatorship)