Clinical Trial: Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: University of Southern California

Current Primary Outcome: Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years [ Time Frame: Baseline and 2 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 1 year [ Time Frame: Baseline and 1 year ]
  • Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 2 years [ Time Frame: Baseline and 2 years ]
  • Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year [ Time Frame: Baseline and 1 year ]
  • Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years [ Time Frame: Baseline and 2 years ]
  • Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 1 year [ Time Frame: Baseline and 1 year ]
    Nerve conduction velocity testing of the median nerve includes physiological measurement of the ability of the nerve to conduct electrical signals using nerve conduction testing equipment (Sierra Wave) with a surface stimulator at the wrist and surface electrodes on the second and fifth digits.
  • Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 2 years [ Time Frame: Baseline and 2 years ]
    Nerve conduction velocity testing of the median nerve includes physiological measurement of the ability of the nerve to conduct electrical signals using nerve conduction testing equipment (Sierra Wave) with a surface stimulator at the wrist and surface electrodes on the second and fifth digits.


Original Secondary Outcome:

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


Information By: University of Southern California

Dates:
Date Received: October 23, 2015
Date Started: July 1, 2016
Date Completion: September 2019
Last Updated: March 7, 2017
Last Verified: March 2017