Development of Multidimensional Screening Tool for WMSDs
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Survey Administration.
- Who it may be relevant to
- Registry conditions: Work-Related Musculoskeletal Disorders, Musculoskeletal Diseases, Occupational Diseases. Basic parameters: 19 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation of a Multidimensional Screening Tool for Work-Related Musculoskeletal Disorders: A COSMIN-Guided Psychometric Study
Overview
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.
Detailed 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.
Interventions
- Other Survey Administration
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.
Primary outcome measures
- Structural Validity [Time frame: Baseline]
Secondary outcome measures (4)
- Internal Consistency [Time frame: Baseline]
- Measurement Invariance [Time frame: Baseline]
- Construct Validity [Time frame: Baseline]
- Cut-off Determination for Yellow Flags [Time frame: Baseline]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 1 center
- Samsung Biologics — Incheon
Identifiers
NCT: NCT07367646 · SYU 2025-12-018-001