Development of Multidimensional Screening Tool for WMSDs

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Musculoskeletal Diseases; Occupational Diseases; Work-Related Musculoskeletal Disorders
• Intervention / Treatment: Other: Survey Administration

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.

• Study Type: Observational
• Enrollment (Estimated): 250

Contacts and Locations

• Study Contact: Name: Kibum Jung, Master of Science; Phone Number: +82 10-9899-3276; Email: kibum921031@gmail.com

Study Locations

• South Korea
  • Incheon, South Korea, 21987
    • Samsung Biologics
    • Contact: Kibum Jung, Master of Science; Phone Number: +82 10-9899-3276; Email: kibum921031@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internal Consistency	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).	Baseline
Measurement Invariance	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).	Baseline
Construct Validity	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.	Baseline
Cut-off Determination for Yellow Flags	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.	Baseline

Collaborators and Investigators

• Sponsor: Sahmyook University

Study record dates

Study Major Dates

• Study Start (Estimated): June 20, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Musculoskeletal Pain; Psychometrics; Occupational Health; Screening Tool; WMSDs
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Muscular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Musculoskeletal Pain; Musculoskeletal Diseases; Occupational Diseases
• Other Study ID Numbers: SYU 2025-12-018-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be shared to protect the privacy and confidentiality of the participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No