NCT07367646

Brief Summary

The purpose of this study is to develop a multidimensional screening tool for Work-Related Musculoskeletal Disorders (WMSDs) and to evaluate its psychometric properties. The study involves a cross-sectional survey of approximately 250 workers in the bio-pharmaceutical industry to assess the tool's structural validity, internal consistency, construct validity, and measurement invariance following COSMIN guidelines.

Trial Health

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Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 20, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

January 17, 2026

Last Update Submit

April 22, 2026

Conditions

Keywords

WMSDsMusculoskeletal PainScreening ToolPsychometricsOccupational Health

Outcome Measures

Primary Outcomes (1)

  • Structural Validity

    Evaluated using Confirmatory Factor Analysis (CFA). Model fit will be assessed based on stricter criteria: CFI ≥ 0.95, TLI ≥ 0.95, RMSEA ≤ 0.06, and SRMR ≤ 0.08 (Hu \& Bentler, 1999). If model fit is insufficient, modification indices (MI) will be used to adjust the model within theoretically justifiable limits.

    Baseline

Secondary Outcomes (4)

  • Internal Consistency

    Baseline

  • Measurement Invariance

    Baseline

  • Construct Validity

    Baseline

  • Cut-off Determination for Yellow Flags

    Baseline

Study Arms (1)

Bio-pharmaceutical Industry Workers

Workers currently employed at Samsung Biologics, including both office and production staff, who meet the inclusion criteria for musculoskeletal symptoms.

Other: Survey Administration

Interventions

Participants will complete the newly developed multidimensional screening tool and standard validation questionnaires (e.g., OSPRO-YF, FABQ, TSK) to assess musculoskeletal symptoms and psychosocial factors.

Bio-pharmaceutical Industry Workers

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of workers currently employed at a bio-pharmaceutical company (Samsung Biologics) in South Korea. This includes both office workers engaged in VDT tasks and production workers involved in physical tasks who report musculoskeletal symptoms.

You may qualify if:

  • Current regular employees working at the study site.
  • Adults aged 19 years or older who understand the study purpose and procedures and voluntarily agree to participate in writing.
  • Participants capable of reading, understanding, and self-responding to the questionnaire.
  • Individuals with musculoskeletal symptoms according to NIOSH standards: symptoms lasting more than one week OR recurring at least once a month in the past 12 months (symptoms include pain, aching, stiffness, burning sensation, tingling, or numbness).

You may not qualify if:

  • Individuals with cognitive or mental impairments that make it difficult to understand the study or complete the survey.
  • Individuals suspected of having a medical emergency or severe disease requiring immediate medical attention.
  • Individuals deemed unsuitable for participation by the researcher.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Biologics

Incheon, 21987, South Korea

Location

MeSH Terms

Conditions

Musculoskeletal DiseasesOccupational DiseasesMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Muscular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Kibum Jung, Master of Science

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ph.D. Candidate

Study Record Dates

First Submitted

January 17, 2026

First Posted

January 26, 2026

Study Start (Estimated)

June 20, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect the privacy and confidentiality of the participants.

Locations