The Effectiveness of Night Splinting After Collagenase Injection for Dupuytren's Contracture
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Range of motion
研究概览
简要总结
The BOND study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for Dupuytren's Contracture.
详细描述
This trial will assess the effectiveness of night splinting in Dupuytrens' contracture on functional and quality of life outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Initial heath-care provider and participant are not masked as would be impossible to do so. Outcome assessor (a different health care provider) and investigators will be masked as to whether the patient is in the splinted or unsplinted cohort.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single digit contractures greater than 30 degrees
- •No prior surgery for their contractures.
- •Successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension).
排除标准
- •Multiple digit contractures
- •Prior surgery for their contractures.
- •Failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension).
- •Inability to consent to treatment.
结局指标
主要结局
Range of motion
时间窗: At 0 weeks, 12 weeks and 52 weeks
To assess change in range of motion measured in degrees between pre-treatment, immediately post-treatment, 12 weeks post-treatment and 12 months post-treatment
次要结局
- URAM Questionnaire(At 0 weeks, 12 weeks and 52 weeks)
- PEM Questionnaire(At 0 weeks, 12 weeks and 52 weeks)