Carpal Tunnel Syndrome: Diagnosis and Treatment Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Carpal Tunnel Syndrome Assessment Questionnaire- function scale
研究概览
简要总结
The Carpal Tunnel Syndrome Diagnosis and Treatment Trial is project #1 of the Multidisciplinary Clinical Research Center focused on upper extremity pain. It is a randomized trial comparing surgical and nonsurgical treatments for patients with early, mild to moderate carpal tunnel syndrome. In addition the study will evaluate the ability of a new magnetic resonance (MR) technique at predicting who will likely benefit from carpal tunnel syndrome (CTS) surgery.
详细描述
While there is good evidence that patients with severe CTS benefit from surgery, there is less evidence of a benefit for patients with mild to moderate disease. However, mild to moderate disease still accounts for important disability. Electrodiagnostic studies (EDS) have not been shown to accurately predict outcomes for patients with CTS. Recent advances in MR permit high-resolution neurographic imaging of the median nerve, and pilot data suggest that wrist MRI might be a better predictor of outcome than EDS. Thus, wrist MRI has the potential for playing a major role in the treatment of patients with CTS. We will test two main hypotheses: 1) that select patients with early, mild or moderate CTS benefit more from early surgery than with conservative therapy; and, 2) that wrist MRI accurately identifies those patients more likely to benefit from surgery. We will perform a randomized, controlled treatment trial nested within a prospective cohort as our study design.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paresthesias involving 2 digits on hand diagram
- •Willingness and ability to complete interviews
排除标准
- •Evidence of denervation on EDS
- •Abnormal 2-pt discrimination or thenar atrophy
- •Prior wrist surgery or acute external trauma
- •MRI contraindications
- •Metallic hardware in wrists
结局指标
主要结局
Carpal Tunnel Syndrome Assessment Questionnaire- function scale
时间窗: 12 months
次要结局
- CTSAQ-function(3 months)
- CTSAQ-symptom(3 months)
- SF36(12 months)
- CTSAQ symptom scale(12 months)
研究者
Jeffrey G. Jarvik, MD, MPH
Study Principal Investigator
University of Washington
