Status:
RECRUITING
DEgenerative ROtator Cuff Disease and Botulinum TOXin
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Merz Pharmaceuticals GmbH
Conditions:
Degenerative Rotator Cuff Disease
Eligibility:
All Genders
41+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.
Detailed Description
Epidemiology: degenerative rotator cuff disease ranks first in shoulder disorders and is the main cause of chronic shoulder pain in general practice and in rheumatology clinics. It can be responsible...
Eligibility Criteria
Inclusion
- 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.
- Negative urine test for women of childbearing age
Exclusion
- 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 and spectinomycine;
- 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 who have not performed a urine pregnancy test and or who have a positive urine pregnancy test;
- in case of pregnancy, breastfeeding
- injection of botulinum toxin in the last 6 months
- vulnerable people (under legal protection, guardianship or curatorship)
Key Trial Info
Start Date :
January 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05327972
Start Date
January 20 2023
End Date
February 1 2027
Last Update
June 27 2025
Active Locations (1)
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1
Hôpital LARIBOISIERE
Paris, Paris, France, 75010