Clinical Trials in France / NCT05327972
Recruiting
Phase 2
DEgenerative ROtator Cuff Disease and Botulinum TOXin
NCT05327972 · tracked via the Priya Life Science France tracker
Condition(s) studied
Degenerative Rotator Cuff Disease
Investigational drug(s) / intervention(s)
The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).PLACEBO
The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).: Two milliliters of a mixture comprised of XEOMIN® 100 U and saline solution 0.9% will be once injected in the supra-spinatus muscle using ultrasonography guidance.
PLACEBO: Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.
Study summary
The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.
Eligibility
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.
* Negative urine test for women of childbearing age
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 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)
Primary outcome measure(s)
- Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100; — 1 month
Total score of the Shoulder Pain And Disability Index : Scale : 0 to 100, with higher score meaning worst outcome
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Hôpital LARIBOISIERE | Paris | Paris | Recruiting |
More Assistance Publique - Hôpitaux de Paris trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05327972 on ClinicalTrials.gov ↗ ← All trials in France