NCT02587897

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2016

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2020

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2023

Completed
Last Updated

January 28, 2025

Status Verified

September 1, 2023

Enrollment Period

3.7 years

First QC Date

October 23, 2015

Last Update Submit

January 23, 2025

Conditions

Carpal Tunnel Syndrome

Keywords

UltrasonographyNerve Conduction VelocityErgonomicsWork Related InjuryCumulative Trauma Disorders

Outcome Measures

Primary Outcomes (1)

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

    Baseline and 2 years

Secondary Outcomes (6)

  • 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

    Baseline and 1 year

  • +1 more secondary outcomes

Study Arms (2)

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 CourseworkOther: Work-Related Hand Activities

Occupational Therapy Students

Students enrolled in the 2-year occupational therapy academic coursework program at the University of Southern California.

Other: Academic Coursework

Interventions

Academic CourseworkOTHER

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.

Dental Hygiene StudentsOccupational Therapy Students
Work-Related Hand ActivitiesOTHER

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.

Dental Hygiene Students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Loma Linda Univeristy Dental Hygiene Program

Loma Linda, California, 92350, United States

Location

USC Musculsokeletal Sonography & Occupational Performance Laboratory

Los Angeles, California, 90033, United States

Location

USC Dental Hygiene

Los Angeles, California, 90089, United States

Location

Related Publications (13)

  • 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.

    PMID: 38074490BACKGROUND

  • 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.

    PMID: 39430719BACKGROUND

  • 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.

    PMID: 38173294BACKGROUND

  • Grutzmacher I, Schicht R, Schlaeger R, Sill V. [Hemodynamics of pulmonary circulation in patients with chronic obstructive lung disease and pulmonary hypertension as dependent on the theophylline concentration of the serum]. Prax Klin Pneumol. 1984 Jan;38(1):19-25. No abstract available. German.

    PMID: 6709589BACKGROUND

  • Sloan H. J. Maxwell Chamberlain, 1906-1968. Ann Thorac Surg. 1981 Aug;32(2):109-10. doi: 10.1016/s0003-4975(10)61016-8. No abstract available.

    PMID: 7020616BACKGROUND

  • 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.

    PMID: 6214479BACKGROUND

  • A WHO Meeting. Prevention of hepatocellular carcinoma by immunization. A WHO meeting. Bull World Health Organ. 1983;61(5):731-44.

    PMID: 6317213BACKGROUND

  • 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.

    PMID: 34656782BACKGROUND

  • 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.

    PMID: 34648193BACKGROUND

  • 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.

    PMID: 34242536BACKGROUND

  • 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.

    PMID: 34219697BACKGROUND

  • 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.

    PMID: 33008947BACKGROUND

  • 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.

    PMID: 37654772BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromeCumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesSprains and StrainsWounds and Injuries

Study Officials

  • Shawn C Roll, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

July 1, 2016

Primary Completion

March 27, 2020

Study Completion

June 7, 2023

Last Updated

January 28, 2025

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will share

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.

Locations

US(3)