Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals

Carpal Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587897
• Other study ID #: HS-15-00004
• Secondary ID: 1R01OH010665-01A
• Status: Completed
• Start date: July 2016
• Est. completion date: June 7, 2023

Study information

• Verified date: September 2023
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: June 7, 2023
• Est. primary completion date: March 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Loma Linda Univeristy Dental Hygiene Program	Loma Linda	California
United States	USC Dental Hygiene	Los Angeles	California
United States	USC Musculsokeletal Sonography & Occupational Performance Laboratory	Los Angeles	California

Sponsors (4)

Lead Sponsor	Collaborator
University of Southern California	Loma Linda University, National Center for Dental Hygiene Research and Practice, National Institute for Occupational Safety and Health (NIOSH/CDC)

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. — View Citation

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: 10.1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years		Baseline and 2 years
Secondary	Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 1 year		Baseline and 1 year
Secondary	Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 2 years		Baseline and 2 years
Secondary	Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year		Baseline and 1 year
Secondary	Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years		Baseline and 2 years
Secondary	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
Secondary	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