DEgenerative ROtator Cuff Disease and Botulinum TOXin

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Apr 7, 2022

Keywords

ClinConnect Summary

The clinical trial titled "DEgenerative ROtator Cuff Disease and Botulinum TOXin" is studying whether a treatment called botulinum toxin can help relieve persistent shoulder pain caused by degenerative rotator cuff disease. This condition often involves pain and weakness in the shoulder due to damage to the rotator cuff tendons. The trial is currently recruiting participants who are over 40 years old, have experienced shoulder pain for more than a month, and have a certain level of pain intensity. To join, participants need to have a specific diagnosis confirmed by an ultrasound and must not have had certain recent medical treatments or conditions.

If you or someone you know is eligible and decides to participate, you can expect to receive treatment and attend scheduled visits to monitor your progress. Throughout the trial, participants will be asked to keep a weekly notebook to track any medications taken for pain. It's important to note that women of childbearing age will need to use effective contraception and undergo a pregnancy test before joining. This trial aims to explore a new approach to managing shoulder pain, which could potentially improve the quality of life for those affected by this condition.

Gender

ALL

Eligibility 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.
• • 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)