Hand Therapy or Not Following Collagenase Treatment for Dupuytren's Contracture?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year.
研究概览
简要总结
This study evaluates if hand therapy have an impact on the patients' preformance of and satisfaction with everyday activities or not following collagenase injection treatment for Dupuytren's contracture. Differences on this between patients with contracted proximal interphalangeal joint(s) and patients with affected metacarpophalangeal joint(s) only, will also be investigated. Two equal sized groups will either receive hand therapy or no treatment following the injection and extension procedure.
详细描述
Today it varies if patients with collagenase treated Dupuytren's contracture (DC) are referred to hand therapy or not. No studies are found looking at the effect of therapy following collagenase treatment compared to no therapy.
The main purpose of the study is to find if hand therapy improves patients' performance of and satisfaction with everyday activities or not, one year after collagenase treatment for DC. Differences on this between patients with contracted proximal interphalangeal joint(s) (PIPJ) and patients with affected metacarpophalangeal joint(s) (MCPJ) only, will also be investigated.
A Norwegian randomised controlled trial will be conducted with two parallel intervention groups in a pre-test - post-test design. Hand therapy includes oedema control, scar management, night-time splinting, movement exercises and use of everyday activities as therapy. Additional individualised therapy will be provided if needed. Test times are right before, straight after, six weeks, four months and one year after collagenase treatment. Sample size needed is 160 participants. Appropriate methods of statistical analysis will be used.
Discussion Research on DC is challenging as the clinical picture is heterogeneous, no cure exists and no agreement on who should receive collagenase treatment. Hand therapy in the study will be individualised and not equal for every patient.
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 (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients treated with collagenase injection and extension procedure for Dupuytren's contracture
排除标准
- •earlier injury or treatment for Dupuytren's contracture in the same finger
- •patients not capable of following a therapy program
- •before randomisation: infection or an allergic reaction to the drug or Complex regional pain syndrome arising
- •earlier participation in the same study makes the participant not eligible to be included once more when treated in the other hand.
结局指标
主要结局
Canadian Occupational Performance Measure (COPM) change from baseline to 6 weeks, from baseline to 4 months and to 1 year.
时间窗: change from baseline to 6 weeks, baseline to 4 months and to 1 year.
An individualized, client-centred outcome measure. COPM is an evidence-based outcome measure designed to capture a patient's self-perception of performance in everyday living, over time.
次要结局
- Change in grip force from baseline to 6 weeks, from baseline to 4 months and to 1 year.(Change from Baseline to 6 weeks from baseline to 4 months and to 1 year)
- Change on Visual Analogue Scale of pain (VAS) from baseline to 6 weeks, from baseline to 4 months and to 1 year.(Change from Baseline to 6 weeksfrom baseline to 4 months and to 1 year)
- Change on Range of motion (ROM) from baseline to 6 weeks, from baseline to 4 months and to 1 year.(Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year)
- Change on Unité Rhumatoloique des Affections de la Main (URAM) scale results from baseline to 6 weeks, from baseline to 4 months and to 1 year.(Change from Baseline to 6 weeks, from baseline to 4 months and to 1 year)