Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals

January 23, 2025 updated by: Shawn Roll, University of Southern California

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
176

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda Univeristy Dental Hygiene Program
      • Los Angeles, California, United States, 90033
        • USC Musculsokeletal Sonography & Occupational Performance Laboratory
      • Los Angeles, California, United States, 90089
        • USC Dental Hygiene

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

We will enroll a total of 120 dental hygiene students from the University of Southern California (USC) and Loma Linda University (LLU), as well as 60 occupational therapy students from USC.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Dental Hygiene Students
Students enrolled in the 2-year dental hygiene academic coursework programs at the University of Southern California and Loma Linda University who are exposed to high-intensity work-related hand activities as part of their training program.
Other: Academic Coursework
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.
Other: Work-Related Hand Activities
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.
Occupational Therapy Students
Students enrolled in the 2-year occupational therapy academic coursework program at the University of Southern California.
Other: Academic Coursework
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years
Time Frame: Baseline and 2 years
Baseline and 2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
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
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.
Baseline and 1 year
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.
Baseline and 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute for Occupational Safety and Health (NIOSH/CDC)
Loma Linda University
National Center for Dental Hygiene Research and Practice

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Shawn C Roll, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 27, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 7, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 27, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-15-00004
  • 1R01OH010665-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once manuscripts from the project become available, datasets used to produce manuscripts will be shared with individual peers under the auspices of the PI. Only de-identified data in final databases, will be shared; raw data will not be shared. Data from secondary analyses beyond the specific aims will only be shared under the auspices of the investigators involved. When authorized, data will be made available to requestors under a data-sharing agreement that provides for: (1) using the data for research only, (2) securing the data using appropriate techniques, (3) destroying or returning the data after analyses are completed, and (4) providing the PI with a summary of how the data were used. Requestors agree to protect the intellectual property rights of the PI, or other investigators as indicted, by appropriately acknowledging the source of the data in any document or presentation, which may include oversight or authorship on work that is based substantially on the shared data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings