Effectiveness at 3 Months of Immediate Shoulder Mobilisation Versus Conventional Immobilisation for Impacted Nonsurgically Treated Proximal Humerus Fracture: a Randomised Controlled Trial.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
研究概览
简要总结
Background: Nonsurgical proximal humerus fracture is common, causing prolonged disability, for which the time to begin rehabilitation is not well determined. We assessed the feasibility and efficacy of early (within 3 days'after fracture) mobilisation of the shoulder compared with conventional 3-week immobilization followed by physiotherapy.
详细描述
Methods: We randomly assigned 74 patients with impacted nonsurgically treated proximal humerus fracture to receive early passive mobilisation or conventional-treatment. The primary outcome was functional assessment of the shoulder (Constant score) at 3 months. Secondary outcomes were functional assessment at 6 weeks and at 6 months, change in pain (on a visual analogue scale) and passive range of motion.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Impacted nonsurgically treated proximal humerus fracture
- •Patients over the age 20
排除标准
- •Pre-existing shoulder pathology
- •Neurological disorders of the upper limbs
- •Indication for surgery of the shoulder
- •Combined polytrauma
- •Difficulties with language or comprehension to understand a rehabilitation program and information
结局指标
主要结局
The primary outcome was functional assessment of the shoulder (Constant score) at 3 months.
次要结局
- Functional assessment at 6 weeks and at 6 months
- Change in pain (on a visual analogue scale)at 6 weeks, 3 months and at 6 months
- Passive range of motion at 6 weeks, 3 months and at 6 months.