Effectiveness of Night Splinting After Percutaneous Needle Fasciotomy in Dupuytren's Contracture - a Randomised Controlled Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 154
- 试验地点
- 3
- 主要终点
- Reduction of finger joint contracture
研究概览
简要总结
Dupuytren's contracture (DC) is associated with progressive finger flexion and extension deficit caused by fibrosis in the palm and digits. Treatment options include minimally invasive procedures such as percutaneous needle fasciotomy (PNF) and collagenase clostridium histolyticum injections as well as open fasciectomy. PNF has recently become more popular in Sweden because it is an office-based procedure which is relatively easy to perform without the usual risks and costs of open surgery.
After treatment with PNF patients usually continue with supervised rehabilitation, which includes physical therapy and night splinting. Whether night splinting is beneficial in terms of reducing recurrence of DC is currently debated.
This study aims to investigate whether night splinting after performed PNF helps to reduce recurrence rate or not. Patients who meet the inclusion criteria will be randomized into two groups: The first group will be treated as usual with physical therapy and night splinting after PNF. The second group will be treated with physical therapy without night splinting after PNF. Follow up includes physical examination regarding active range of motion, sensation and grip strength at procedure day and 2 weeks, 3, 12 and 36 months later as well as questionnaires regarding hand function, pain and quality of life at procedure day and 3, 12 and 36 months later. Patients who are randomized into the second group (no night splinting) will also be examined 3 weeks after PNF for observation in case of an early impairment regarding extension deficit.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years of age and older,
- •Palpable Dupuytren strand with passive extension deficit according to stadium 1 and 2 of the classification of Tubiana in one or two fingers excluding the thumb, defined as at least 30 degrees in the MCP joint and/or at least 20 degrees in the PIP joint and a maximum of 75 degrees in the MCP or PIP joint
排除标准
- •Multiple, invasive or wide strands in the palm,
- •Skin irritation,
- •Strand localization in the digit only,
- •Digital nerve injury,
- •Any former treatment for Dupuytren's contracture in the same digit,
- •Thumb contracture,
- •Stadium 3 and 4 according to the classification of Tubiana
研究组 & 干预措施
Treatment with night splint after percutaneous needle fasciotomy
No treatment with night splint after percutaneous needle fasciotomy
干预措施: No night splint (Other)
结局指标
主要结局
Reduction of finger joint contracture
时间窗: at 1 year follow up
Finger joint movement in order to extend the finger measured in degrees with a goniometer before and after treatment.
次要结局
- Quality of life assessed by EQ-5D(before treatment, at 3, 12 and 36 months follow-up)
- Dupuytren-disease-associated disability assessed by URAM(before treatment, at 3, 12 and 36 months follow-up)
- Study specific questionnaire concerning the patient's medical history(before treatment, at 3, 12 and 36 months follow-up)
- Pain assessed by a numeric rating scale (NRS)(before treatment, at 3, 12 and 36 months follow-up)
- Semmes-Weinstein monofilament test(before treatment, at 3, 12 and 36 months follow-up)
- Change of active finger flexion(before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up)
- Change of grip strength(before and after treatment, at 2 weeks, 3, 12 and 36 months follow-up)