Evaluation of the Effectiveness of ARTHRO -Distension Plus Intensive Mobilisation in Shoulder Capsulitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Pain and disability using SPADI score at 2 weeks
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of ARTHRO distension plus intensive mobilisation in shoulder capsulitis.
详细描述
The aim of the study is to evaluate a treatment of shoulder capsulitis that associates ARTHRO distension and intensive mobilisation at 2, 6, 12, 26 and 52 weeks. It is a bicentric 87-month (inclusion: 74 months; follow up: 13 months) observer blind randomised clinical trial using 2 groups in parallel. The number of patients to be included is 66. The treatment that is evaluated associates ARTHRO distension followed by mobilisation of the shoulder 6 hours per day during 5 days, and then sessions of physiotherapy for 4 weeks. The control intervention is one intra-articular injection of corticosteroids and physiotherapy. The primary outcome is SPADI, namely pain and disability, at 2 weeks.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 18 years
- •shoulder capsulitis
- •duration of symptoms ≥ 3 months
- •health insurance
排除标准
- •cognitive disorders
- •Hypo coagulation
- •biological inflammatory syndrome
- •uncontrolled diabetes
- •XYLOCAINE allergy
- •pregnancy
- •unable to understand and to speak french
- •previous surgery of shoulder
- •shoulder infiltration or distension in the previous month
- •local contraindication to shoulder infiltration
研究组 & 干预措施
1
infiltration intra articular
干预措施: infiltration intra articular (Procedure)
2
ARTHRO distension plus intensive mobilisation
干预措施: ARTHRO distension plus intensive mobilisation (Procedure)
结局指标
主要结局
Pain and disability using SPADI score at 2 weeks
时间窗: at 2 weeks
次要结局
未报告次要终点