Postoperative Therapy After Interposition Arthroplasty in CMC1
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
研究概览
简要总结
In this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a faster recovery of hand function. The investigators also want to explore patients' satisfaction with the two different treatment regimes. The participants in the control group will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. The participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. A total of 70 patients will be included in the study.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
- •Planned surgery(interposition arthroplasty) in CMC1
- •Ability to communicate in Norwegian
排除标准
- •Surgery involving other joints of the hand in addition to CMC
- •Previous surgery of the same thumb.
- •Other diseases og injuries that could influence hand function.
- •Mental or cognitive deficit.
结局指标
主要结局
Change from baseline in The Canadian Occupational Performance Measure (COPM) at 3, 6 and 12 months.
时间窗: Baseline, 3, 6 and 12 months
The COPM-assessment starts with an interview, addressing patient specific Hand Osteoarthritis (HOA)-related activity limitations within the areas self-care, productivity and leisure. The patient will thereafter rate the five most important activities for performance and satisfaction with performance, on 1 to 10-point scales (higher scores reflect better performance or higher satisfaction). The Norwegian version of the COPM has been tested for validity, reliability and responsiveness and has demonstrated good ability to detect functional changes in HOA.
Change from baseline in Patient satisfaction with the rehabilitation regimen at 3, 6 and 12 months.
时间窗: Baseline, 3, 6 and 12 months
Each patient will be asked to complete a Numeric Rating Scale in order to give an opinion about their postoperative treatment regimen (splint-use, hand function, pain in the thumb, thumb movement and satisfaction with the operation).
次要结局
- Measure for activity performance (MAP-hand).(Baseline, 3, 6 and 12 months)
- Grip force and pinch grip(Baseline, 3, 6 and 12 months)
- Joint mobility(Baseline, 3, 6 and 12 months)
- Pain(Baseline, 3, 6, and 12 months)
研究者
Tove Nilsen
Occupational therapist MSc
Diakonhjemmet Hospital