Study of the Effectiveness of Mechanical Traction as a Non-Surgical Treatment for Carpal Tunnel Syndrome Compared to Care as Usual: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 181
- 试验地点
- 2
- 主要终点
- Change from baseline in symptom severity and functional status on the Boston Carpal Tunnel Questionnaire (BCTQ) at 12 months
研究概览
简要总结
The objective of this study is to evaluate the effectiveness of mechanical traction in patients with Carpal Tunnel Syndrome compared to care as usual.
详细描述
This randomized controlled trial will examine the effectiveness of mechanical traction compared to care as usual as a non-surgical treatment for Carpal Tunnel Syndrome (CTS).
Patients diagnosed with CTS are recruited from the outpatient neurology clinic of VieCuri Medical Center in Venlo, The Netherlands. They will be randomly assigned to the intervention or control group. Patients in the intervention group will receive 12 treatments with mechanical traction during six consecutive weeks. Patients in the control group will receive care as usual, which can include splinting, a corticosteroid injection, carpal tunnel release surgery or an expectant strategy. Outcomes will be assessed at baseline and at 3, 6, and 12 months after inclusion.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with CTS using electrodiagnostic testing
- •being physically capable of visiting the outpatient clinic in Venlo twice per week
- •being physically capable of sitting in upright position in a chair for 10-20 minutes, twice per week
- •not intending to move outside the area within 3 months after inclusion
排除标准
- •not understanding Dutch appropriately
- •other known (rare) cause of neuropathy
- •suffering from severe psychiatric disorders, such as personality disorder, schizophrenia or bipolar disorder
结局指标
主要结局
Change from baseline in symptom severity and functional status on the Boston Carpal Tunnel Questionnaire (BCTQ) at 12 months
时间窗: Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.
Functional status and symptom severity will be measured using a self-reported scale: the BCTQ. The BCTQ is a disease-specific questionnaire and consists of two different scales: the Symptom Severity Scale (SSS) and the Functional Status Scale (FSS). The SSS consists of 11 questions about symptom severity. The FSS consists of 8 daily activities which are rated based on degree of difficulty. The SSS and the FSS are rated on a five-point scale, where a higher score represents a greater impairment.
次要结局
- Change from baseline in quality of life on abbreviated version of the World Health Organisation Quality of Life (WHOQOL-BREF)(Baseline, 6 weeks (intervention group) and 3, 6 and 12 months.)
- Change from baseline in absenteeism from work(Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.)
- Change from baseline in health care related resource utilization(Baseline, 3 and 6 weeks (intervention group) and 3, 6 and 12 months.)
研究者
prof.dr. Victor J Pop
Prof. Dr. V.J.M. Pop
Tilburg University