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NCT Number: NCT02587897

Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals

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.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Loma Linda Univeristy Dental Hygiene Program, Loma Linda, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Academic Coursework

Other

Didactic training provided by the university through coursework and laboratory training that meets requirements of the accreditation standards provided by the professional society associated with each professional degree granting program.

Work-Related Hand Activities

Other

Exposure to intensive training in the use of dental scaling tools as part of laboratory courses, as well as fieldwork and residency training during the academic degree program.

Primary outcomes

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

    Time frame: Baseline and 2 years

Secondary outcomes

  1. 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

  2. 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

  3. Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year

    Time frame: Baseline and 1 year

  4. Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years

    Time frame: Baseline and 2 years

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • Loma Linda University
  • National Center for Dental Hygiene Research and Practice
  • National Institute for Occupational Safety and Health (NIOSH/CDC)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2023
First posted
Oct 27, 2015
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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