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临床试验/NCT00032227
NCT00032227已完成不适用

Carpal Tunnel Syndrome: Diagnosis and Treatment Trial

University of Washington2 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2002年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeffrey G. Jarvik, MD, MPH

Study Principal Investigator

University of Washington

研究点 (2)

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