DEgenerative ROtator Cuff Disease and Botulinum TOXin: a Randomized Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100;
研究概览
简要总结
The aim of the study is to assess the effectiveness of botulinum toxin in persistent shoulder pain due to degenerative rotator cuff disease.
详细描述
Epidemiology:
degenerative rotator cuff disease ranks first in shoulder disorders and is the main cause of chronic shoulder pain in general practice and in rheumatology clinics. It can be responsible for persistent shoulder pain, functional limitation and greatly contributes to occupational disability.
The pathogenesis of rotator cuff disease:
involves tendon impingement and intrinsic tendinopathic abnormality (supra-spinatus, infra-spinatus, teres minor and sub-scapularis muscles). They include apoptosis of the tenocytes that is induced by mechanical constraints and by local hypoxia. The consequences are secondary inflammation and matrix alteration.
Current therapeutic approach:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 41 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
1- Botulinum toxin
The investigational medicinal product is incobotulinumtoxinA (XEOMIN®).
The dosage is:
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.
干预措施: The investigational medicinal product is incobotulinumtoxinA (XEOMIN®). (Drug)
2- PLACEBO
The placebo comparator represents a saline solution containing an inactive lyophilisate.
The dosage is:
Two milliliters of a saline solution containing an inactive lyophilisate will be once injected in the supra-spinatus muscle using ultrasonography guidance.
干预措施: PLACEBO (Other)
结局指标
主要结局
Total score of the Shoulder Pain And Disability Index at 1 month. 0 to 100;
时间窗: 1 month
Total score of the Shoulder Pain And Disability Index : Scale : 0 to 100, with higher score meaning worst outcome
次要结局
- Sub-scores for pain and disability of the Shoulder Pain And Disability Index at 1 month and 3 months Total score of the Shoulder Pain And Disability Index at 3 months Safety at 1 week, 1 month and 3 months(week, 1 month and 3 months)