Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals

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: Completed
• Conditions: Carpal Tunnel Syndrome
• Intervention / Treatment: Other: Academic Coursework; Other: Work-Related Hand Activities

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: Observational
• Enrollment (Actual): 176

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Time Frame
Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years	Baseline and 2 years

Secondary Outcome Measures

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		Baseline and 1 year
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 Vascularity within the Median Nerve Measured with Doppler 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 Nerve Conduction Velocity of the Median Nerve at 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	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

• Sponsor: University of Southern California
• Collaborators: National Institute for Occupational Safety and Health (NIOSH/CDC); Loma Linda University; National Center for Dental Hygiene Research and Practice
• Investigators: Principal Investigator: Shawn C Roll, PhD, University of Southern California

Publications and helpful links

General Publications

• Roll SC, Tung KD, Chang H, Sehremelis TA, Fukumura YE, Randolph S, Forrest JL. Prevention and rehabilitation of musculoskeletal disorders in oral health care professionals: A systematic review. J Am Dent Assoc. 2019 Jun;150(6):489-502. doi: 10.1016/j.adaj.2019.01.031. Epub 2019 Apr 25.
• Takata SC, Kysh L, Mack WJ, Roll SC. Sonographic reference values of median nerve cross-sectional area: a protocol for a systematic review and meta-analysis. Syst Rev. 2019 Jan 3;8(1):2. doi: 10.1186/s13643-018-0929-9.
• Roll SC, Hardison ME, Forrest JL, Colclazier NL, Sumi JY, Baker NA. A standardized protocol for the comprehensive assessment of dental hygiene work. Work. 2021;69(3):1041-1052. doi: 10.3233/WOR-213534.
• Yao B, Gan K, Lee A, Roll SC. Comparing Shape Categorization to Circularity Measurement in the Evaluation of Median Nerve Compression Using Sonography. J Diagn Med Sonogr. 2020;2020:10.1177/8756479319898471. doi: 10.1177/8756479319898471. Epub 2020 Jan 8.
• Takata SC, Roll SC. Identification of Aberrant Muscle Bellies in the Carpal Tunnel using Sonography. J Diagn Med Sonogr. 2019 Jan;35(1):62-68. doi: 10.1177/8756479318807469. Epub 2018 Oct 20.
• Pozzi F, Sousa CO, Plummer HA, Andrade B, Awokuse D, Kono N, Mack WJ, Roll SC, Michener LA. Development of shoulder pain with job-related repetitive load: mechanisms of tendon pathology and anxiety. J Shoulder Elbow Surg. 2022 Feb;31(2):225-234. doi: 10.1016/j.jse.2021.09.007. Epub 2021 Oct 14.
• Yao B, Roll SC. An ultrasound study of the mobility of the median nerve during composite finger movement in the healthy young wrist. Muscle Nerve. 2022 Jan;65(1):82-88. doi: 10.1002/mus.27437. Epub 2021 Oct 27.
• Fang Y, Tung KD, Beleno-Sanchez J, Forrest JL, Roll SC. Characterization of Tasks and Time Efficiency of Dental Hygiene Students During Clinical Training. J Dent Hyg. 2020 Oct;94(5):30-37.
• Yao B, Takata SC, Mack WJ, Roll SC. Modeling extracurricular activity participation with physical and mental health in college students over time. J Am Coll Health. 2023 May-Jun;71(4):1232-1240. doi: 10.1080/07448481.2021.1926263. Epub 2021 Jul 9.
• Roll SC, Takata SC, Yao B, Kysh L, Mack WJ. Sonographic reference values for median nerve cross-sectional area: A meta-analysis of data from healthy individuals. J Diagn Med Sonogr. 2023 Sep;39(5):492-506. doi: 10.1177/87564793231176009. Epub 2023 Jun 6.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2016
• Primary Completion (Actual): March 27, 2020
• Study Completion (Actual): June 7, 2023

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimated): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 25, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasonography; Nerve Conduction Velocity; Ergonomics; Work Related Injury; Cumulative Trauma Disorders
• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Median Neuropathy; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Carpal Tunnel Syndrome
• Other Study ID 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