Clinical trial NCT02587897: Musculoskeletal Health of the Upper Extremity in Emerging Health Professionals
Official title: Sonographic Tissue Morphology in Early Stage Work-related Median Nerve Pathology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carpal Tunnel Syndrome
Keywords: Ultrasonography
Nerve Conduction Velocity
Ergonomics
Work Related Injury
Cumulative Trauma Disorders
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute for Occupational Safety and Health (NIOSH/CDC)
name: Loma Linda University
name: National Center for Dental Hygiene Research and Practice
First posted: 2015-10-27
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline in Symptom & Function Reports on the Boston Carpal Tunnel Questionnaire at 2 years
timeFrame: Baseline and 2 years
Secondary outcomes:
measure: Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 1 year
timeFrame: Baseline and 1 year
measure: Change from Baseline in Cross-Sectional Area of Median Nerve in the Carpal Tunnel Measured with Sonography at 2 years
timeFrame: Baseline and 2 years
measure: Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 1 year
timeFrame: Baseline and 1 year
measure: Change from Baseline in Vascularity within the Median Nerve Measured with Doppler Sonography at 2 years
timeFrame: Baseline and 2 years
measure: Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 1 year
timeFrame: Baseline and 1 year
measure: Change from Baseline in Nerve Conduction Velocity of the Median Nerve at 2 years
timeFrame: Baseline and 2 years
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda Univeristy Dental Hygiene Program
state: California
city: Los Angeles
country: United States
facility: USC Musculsokeletal Sonography & Occupational Performance Laboratory
state: California
city: Los Angeles
country: United States
facility: USC Dental Hygiene
state: California
Study officials:
affiliation: University of Southern California
name: Shawn C Roll, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yao B, Evans KD, Roll SC. Assessing the Potential for Error in Investigating Intraneural Vascularity: A Need for a Standardized Imaging Protocol. J Diagn Med Sonogr. 2023 Nov;39(6):549-559. doi: 10.1177/87564793231193396.
citation: Fang Y, Kapellusch JM, Baker NA, Roll SC. CHARACTERIZING PHYSICAL STRAIN IN NON-ROUTINIZED CLINICAL WORK THROUGH OBSERVATION: AN EXAMPLE OF ORAL HEALTHCARE PROVIDERS. Proc Int Symp Hum Factors Ergon Healthc. 2024 Sep;13(1):134-139. doi: 10.1177/2327857924131015.
citation: Loomis KJ, Roll SC. External wrist ratio is not a proxy for internal carpal tunnel shape: Implications for evaluating carpal tunnel syndrome risk. Clin Anat. 2024 Nov;37(8):869-877. doi: 10.1002/ca.24132. Epub 2024 Jan 3.
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citation: Fotter R, Hollwarth M. [Water syphon test and gastro-oesophageal reflux during childhood (correlation with the clinical findings and oesophageal manometry) ]. Rofo. 1981 Jul;135(1):53-6. doi: 10.1055/s-2008-1056830. German.
citation: A WHO Meeting. Prevention of hepatocellular carcinoma by immunization. A WHO meeting. Bull World Health Organ. 1983;61(5):731-44.
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: 10.1016/j.jse.2021.09.007. Epub 2021 Oct 14.
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.
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.
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.
citation: 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.
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.