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DEROTOX : DEgenerative ROtator cuff disease and botulinum TOXin
EU CTIS ID: 2024-514074-40-00
What this study is testing
To evaluate the effectiveness of botulinum toxin in the treatment of degenerative tendinopathy of the rotator cuff of the shoulder, at one month, based on the Shoulder Pain And Disability Index score (SPADI total)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age > 40 years
- Availability for visits planned by the protocol
- 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
- Negative urine test for women of childbearing age
- Duration of pain > 1 month
- Pain intensity ≥ 40/100 on the visual analog scale
You likely can't join if
- Reduced passive range of motion
- Concomitant use of aminoglycosides, cyclosporine, aminoquinolines or spectinomycin
- 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.
- Patients with a history of inhalation pneumonitis and dysphagia
- Patients on anticoagulant therapy or on therapy likely to have an anticoagulant effect
- Patients with bleeding disorders
See the full eligibility criteria
- Age > 40 years
- Availability for visits planned by the protocol
- 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
- Negative urine test for women of childbearing age
- Duration of pain > 1 month
- Pain intensity ≥ 40/100 on the visual analog scale
- SPADI score ≥ 30/100
- Pain medication(s) unchanged within 30 days prior to enrollment
- Pain with or without weakness during the Jobe maneuver
- Ultrasound within 30 days, showing supraspinatus tendinopathy, with or without rupture
- Affiliation to a social security scheme
- Ability to give consent, complete the weekly notebook (collection of medicinal treatments taken for pain)
- Reduced passive range of motion
- Concomitant use of aminoglycosides, cyclosporine, aminoquinolines or spectinomycin
- 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.
- Patients with a history of inhalation pneumonitis and dysphagia
- Patients on anticoagulant therapy or on therapy likely to have an anticoagulant effect
- Patients with bleeding disorders
- Patients suffering from amyotrophic lateral sclerosis, myasthenia gravis or Lambert-Eaton syndrome.
- Patients with other disorders leading to peripheral neuromuscular dysfunction
- Weakness or pronounced atrophy of the supraspinatus muscle
- Women of childbearing age who have not taken a urine pregnancy test or who have taken a positive urine pregnancy test
- Pregnancy, breast-feeding
- Skin infection at the intended injection site
- Botulinum toxin injections within the last 6 months
- Vulnerable persons (under legal protection, guardianship or curatorship).
- Glenohumeral arthropathy
- Painful acromioclavicular arthropathy
- Neurogenic upper limb pain
- Glenohumeral instability
- Tendon calcification
- Ultrasound showing a concomitant rupture of the infraspinatus or subscapularis
- Infiltration of corticosteroids into the shoulder in the 30 days preceding the inclusion visit
- Shoulder surgery
- Humeral fracture, inflammatory rheumatism or neoplastic disease
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.