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临床试验/NCT02587897
NCT02587897已完成不适用

Sonographic Tissue Morphology in Early Stage Work-related Median Nerve Pathology

University of Southern California3 个研究点 分布在 1 个国家目标入组 176 人开始时间: 2016年7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
176
试验地点
3
主要终点
Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years

研究概览

简要总结

Carpal tunnel syndrome is the most expensive upper extremity work-related musculoskeletal disorder, impacting 10 million people annually and costing employers up to $113,695 per incident. There is currently no established method to detect this disorder prior to the onset of symptoms and nerve damage. Preliminary research suggests that sonography-a relatively inexpensive, widely available, increasingly portable technology-can provide a non-invasive and pain-free method of early detection that could reduce incidence, improve targeted interventions and ultimately reduce costs. The primary aims of this study are to establish predictive validity of a novel method for early detection using sonographic imaging and to identify task components of intensive functional hand activity associated with morphologic changes.

详细描述

This longitudinal study will follow dental hygiene students-a high-risk population with minimal retrospective and controlled prospective task exposure-for two years and compare them to a non-exposed cohort of occupational therapy students to investigate the primary aims. This research is directed at the National Occupational Research Agenda's (NORA) Healthcare and Social Assistance sector with a focus on the National Institute of Occupational Safety and Health's (NIOSH) Exposure Assessment and Musculoskeletal Disorders cross-sectors. Intermediate outcomes of this research will establish sonographic imaging as an early detection tool for workplace-screening and inform methods for combining measures of nerve morphology, neurophysiology, and subjective symptoms for predicting the development of work-related carpal tunnel syndrome. This work will also inform the development of targeted preventive interventions for task components of intensive hand activities that are related to changes in tissue morphology. Identifying morphologic changes in early-stages of pathology and the specific task components linked to these changes are the first steps toward early detection and prevention of work-related carpal tunnel syndrome.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Enrollment in one of the academic programs (i.e., register and pay for classes)

排除标准

  • <18 years of age
  • Prior carpal tunnel release surgery
  • Prior diagnosis of median nerve pathology or other poly-neuropathy that includes the median nerve

结局指标

主要结局

Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years

时间窗: Baseline and 2 years

次要结局

  • Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 1 year(Baseline and 1 year)
  • Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years(Baseline and 2 years)
  • Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 2 years(Baseline and 2 years)
  • Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 1 year(Baseline and 1 year)
  • Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year(Baseline and 1 year)
  • Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 2 years(Baseline and 2 years)

研究者

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

Shawn Roll

Associate Professor

University of Southern California

研究点 (3)

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