EUCTR2021-003315-25-FR进行中（未招募）1 期
Botulinum toxin and degenerative rotator cuff tendinopathies: a randomized trial »DEROTOX (DEgenerative ROtator cuff disease and botulinum TOXin) - DEROTOX
未提供0 个研究点目标入组 60 人开始时间: 2022年1月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Age> 40 years old
- •Duration of pain> 1 month
- •Pain intensity = 40/100 on the visual analogue scale
- •SPADI score = 30/100
- •Pain medication (s) unchanged within 30 days of enrollment
- •Pain with or without weakness during Jobe's maneuver (29)
- •Ultrasound within 30 days, showing tendinopathy of the supra-spinatus, with or without rupture
- •Affiliation to a social security scheme
- •Ability to give consent, complete the weekly notebook (collection of drug treatments taken against pain)
- •Availability for the visits provided for by the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •Reduced passive range of motion
- •Glenohumeral instability
- •Tendon calcification
- •Ultrasound showing a concomitant rupture of the infra-spinatus or the subscapularis
- •Corticosteroid infiltration in the 30 days preceding the inclusion visit
- •Shoulder surgery
- •Humeral fracture, inflammatory rheumatism and 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 concerning)
- •Concomitant use of aminosides, ciclosporin, aminoquinolines
- •Skin infection at the intended 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.
- •Pregnancy, breastfeeding
- •Injection of botulinum toxin in the last 6 months
- •Vulnerable people (under legal protection, guardianship or curatorship).
研究者
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