Development of Multidimensional Screening Tool for WMSDs

Sahmyook University

Status: Not yet enrolling

Conditions: Musculoskeletal Diseases; Occupational Diseases; Work-Related Musculoskeletal Disorders

Treatments: Other: Survey Administration

Study type: Observational

Funder types: Other

Identifiers

NCT07367646

SYU 2025-12-018-001

Details and patient eligibility

About

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.

Full description

Work-related musculoskeletal disorders (WMSDs) are a major occupational health issue. While various screening tools exist, few comprehensively assess red flags (signs of serious pathology), yellow flags (psychosocial risk factors), and physical symptoms specifically for industrial workers. This study aims to address this gap by developing a new screening tool and validating its reliability and validity. The study design follows the COSMIN (COnsensus-based Standards for the selection of health Measurement INstruments) checklist. The validation process involves a cross-sectional survey targeting 250 workers, including both office and production staff. The developed tool is designed to screen for serious medical conditions (Red flags) requiring referral, as well as to assess physical symptoms and psychosocial barriers (Yellow flags). Psychometric evaluation will specifically focus on the physical and psychosocial domains, as Red flags are typically binary screening items. Key psychometric properties to be evaluated include: 1. Structural Validity: Confirmatory Factor Analysis (CFA) will be conducted to verify the factor structure of the physical and psychosocial domains. 2. Internal Consistency: Cronbach's alpha coefficients will be calculated for these subscales. 3. Measurement Invariance: Multi-group CFA will be performed to ensure the tool functions equivalently across different job types (office vs. production). 4. Construct Validity: Correlations with established instruments (e.g., OSPRO-YF, FABQ, TSK) will be analyzed. The ultimate goal is to provide a practical and scientifically validated instrument for the early detection, triage, and management of WMSDs in workplace settings. 5. Cut-off Determination: ROC analysis will be conducted to establish optimal cut-off scores for identifying high-risk groups (Yellow flags), using established tools as a reference.

Enrollment: 250 estimated patients

Sex: All

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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).

Exclusion criteria

• 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.

Trial design

250 participants in 1 patient group

Bio-pharmaceutical Industry Workers

Description:

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

Treatment:

Other: Survey Administration