Development of Multidimensional Screening Tool for WMSDs
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-65
SponsorSahmyook University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Survey Administration
Other interventionParticipants 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.
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Bio-pharmaceutical Industry Workers1 intervention
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
1
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).
Time frame
Baseline2
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).
Time frame
Baseline3
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.
Time frame
Baseline4
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.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov
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