CLOSTRIDIUM BOTULINUM NEUROTOXIN TYPE A (150KD), FREE OF COMPLEXING PROTEINS for Degenerative rotator cuff tendinopathy

Inclusion criteria

• {"criterion_text":"- Age > 40 years"}
• {"criterion_text":"- Availability for visits planned by the protocol"}
• {"criterion_text":"- Use of an effective method of contraception in women of childbearing potential that began at least 1 month before and continues for at least 1 month after administration of study treatment"}
• {"criterion_text":"- Negative urine test for women of childbearing age"}
• {"criterion_text":"- Duration of pain > 1 month"}
• {"criterion_text":"- Pain intensity ≥ 40/100 on the visual analog scale"}
• {"criterion_text":"- SPADI score ≥ 30/100"}
• {"criterion_text":"- Pain medication(s) unchanged within 30 days prior to enrollment"}
• {"criterion_text":"- Pain with or without weakness during the Jobe maneuver"}
• {"criterion_text":"- Ultrasound within 30 days, showing supraspinatus tendinopathy, with or without rupture"}
• {"criterion_text":"- Affiliation to a social security scheme"}
• {"criterion_text":"- Ability to give consent, complete the weekly notebook (collection of medicinal treatments taken for pain)"}

Exclusion criteria

• {"criterion_text":"- Reduced passive range of motion"}
• {"criterion_text":"- Concomitant use of aminoglycosides, cyclosporine, aminoquinolines or spectinomycin"}
• {"criterion_text":"- Participation in other interventional research (RIPH) during the 3-month follow-up period of DEROTOX Research. Participation in another RIPH will be possible beyond these 3 months."}
• {"criterion_text":"- Patients with a history of inhalation pneumonitis and dysphagia"}
• {"criterion_text":"- Patients on anticoagulant therapy or on therapy likely to have an anticoagulant effect"}
• {"criterion_text":"- Patients with bleeding disorders"}
• {"criterion_text":"- Patients suffering from amyotrophic lateral sclerosis, myasthenia gravis or Lambert-Eaton syndrome."}
• {"criterion_text":"- Patients with other disorders leading to peripheral neuromuscular dysfunction"}
• {"criterion_text":"- Weakness or pronounced atrophy of the supraspinatus muscle"}
• {"criterion_text":"- Women of childbearing age who have not taken a urine pregnancy test or who have taken a positive urine pregnancy test"}
• {"criterion_text":"- Pregnancy, breast-feeding"}
• {"criterion_text":"- Skin infection at the intended injection site"}
• {"criterion_text":"- Botulinum toxin injections within the last 6 months"}
• {"criterion_text":"- Vulnerable persons (under legal protection, guardianship or curatorship)."}
• {"criterion_text":"- Glenohumeral arthropathy"}
• {"criterion_text":"- Painful acromioclavicular arthropathy"}
• {"criterion_text":"- Neurogenic upper limb pain"}
• {"criterion_text":"- Glenohumeral instability"}
• {"criterion_text":"- Tendon calcification"}
• {"criterion_text":"- Ultrasound showing a concomitant rupture of the infraspinatus or subscapularis"}
• {"criterion_text":"- Infiltration of corticosteroids into the shoulder in the 30 days preceding the inclusion visit"}
• {"criterion_text":"- Shoulder surgery"}
• {"criterion_text":"- Humeral fracture, inflammatory rheumatism or neoplastic disease"}
• {"criterion_text":"- 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 concerned)"}

Primary endpoints

• {"endpoint_text":"- Total SPADI score at 1 month.","definition_or_measurement_approach":"Shoulder Pain And Disability Index (SPADI) total score measured at 1 month"}

Secondary endpoints

• {"endpoint_text":"- Total SPADI score at 3 months","definition_or_measurement_approach":"SPADI total score measured at 3 months"}
• {"endpoint_text":"- SPADI sub-scores at 3 months","definition_or_measurement_approach":"SPADI sub-scores (pain and functional limitation) measured at 3 months"}
• {"endpoint_text":"- Perceived overall improvement, by VAS at 1 and 3 months","definition_or_measurement_approach":"Perceived overall improvement measured by Visual Analogue Scale (VAS/EVA) at 1 and 3 months"}
• {"endpoint_text":"- Painkiller medication consumption over the 3 months of follow-up","definition_or_measurement_approach":"Analgesic medication consumption recorded in a weekly notebook over 3 months"}
• {"endpoint_text":"- Acceptability of treatment by VAS from 0 to 100 at 1 month and 3 months","definition_or_measurement_approach":"Acceptability measured by VAS/EVA 0-100 at 1 and 3 months"}

France

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

03-03-2025

Processing Time Days

256

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France