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NCT Number: NCT07367646

Development of Multidimensional Screening Tool for WMSDs

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.

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Key information

Age range

19 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Survey Administration

Other

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 outcomes

  1. Structural Validity

    Time frame: Baseline

    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.

Secondary outcomes

  1. Internal Consistency

    Time frame: Baseline

    Assessed using Cronbach's alpha coefficients for each factor. A value between 0.70 and 0.90 is considered to indicate appropriate internal consistency (Tavakol & Dennick, 2011).

  2. Measurement Invariance

    Time frame: Baseline

    Evaluated using Multi-group CFA between office workers (VDT tasks) and production workers (physical tasks). Invariance is determined based on criteria such as ΔCFI ≤ 0.01 and ΔRMSEA ≤ 0.015 (Chen, 2007).

  3. Construct Validity

    Time frame: Baseline

    Assessed by analyzing correlations (Pearson or Spearman) between the developed tool and standard instruments. A correlation coefficient (r) of ≥ 0.50 represents adequate convergent validity.

  4. Cut-off Determination for Yellow Flags

    Time frame: Baseline

    Receiver Operating Characteristic (ROC) analysis will be conducted to establish optimal cut-off scores for identifying high-risk groups (Yellow flags). Established instruments (e.g., OSPRO-YF) will be used as a reference to calculate sensitivity, specificity, and the Youden index.

Study contacts

Contact information is provided by the study sponsor or research team.

Kibum Jung, Master of Science

CONTACT

[email protected]

+82 10-9899-3276

Sponsors and collaborators

Lead sponsor

Sahmyook University

Other

Registry information

Official study title

Development and Validation of a Multidimensional Screening Tool for Work-Related Musculoskeletal Disorders: A COSMIN-Guided Psychometric Study

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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