Work-Related Musculoskeletal DisordersNCT07367646
Development of Multidimensional Screening Tool for WMSDs
An observational study of Work-Related Musculoskeletal Disorders and Musculoskeletal Diseases, run by Sahmyook University at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Work-Related Musculoskeletal Disorders, Musculoskeletal Diseases, Occupational Diseases
- What is being tested?
- Survey Administration
- How many people
- 250 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Biologics
Incheon, 21987
Kibum Jung, Master of Science, +82 10-9899-3276, kibum921031@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Survey Administration
- Keywords
- WMSDs, Musculoskeletal Pain, Screening Tool, Psychometrics, Occupational Health
- Medical subject headings
- Musculoskeletal Diseases, Occupational Diseases, Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Bio-pharmaceutical Industry Workers | Workers currently employed at Samsung Biologics, including both office and production staff, who meet the inclusion criteria for musculoskeletal symptoms. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start20 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-Related Musculoskeletal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sahmyook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kibum Jung, Sahmyook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07367646
- Sponsor's protocol ID
- SYU 2025-12-018-001
- Status last verified
- Apr 2026
- First submitted
- 17 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect the privacy and confidentiality of the participants.
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Multidimensional Screening Tool for Work-Related Musculoskeletal Disorders: A COSMIN-Guided Psychometric Study
- ClinicalTrials.gov ID
- NCT07367646
- Acronym / sponsor ID
- SYU 2025-12-018-001
- Keywords
- WMSDs, Musculoskeletal Pain, Screening Tool, Psychometrics, Occupational Health
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Sahmyook UniversityUniversity, hospital or other
- Study start
- 20 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bio-pharmaceutical Industry Workers | – | Other: Survey AdministrationWorkers currently employed at Samsung Biologics, including both office and production staff, who meet the inclusion criteria for musculoskeletal symptoms. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationParticipants 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. | Other | Bio-pharmaceutical Industry Workers |
Primary outcome
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.
4 secondary outcomes
Internal Consistency
Time frame: Baseline
Measurement Invariance
Time frame: Baseline
Construct Validity
Time frame: Baseline
Cut-off Determination for Yellow Flags
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect the privacy and confidentiality of the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-Related Musculoskeletal Disorders and Musculoskeletal Diseases, run by Sahmyook University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kibum Jung, Master of Science (+82 10-9899-3276, kibum921031@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural Validity (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.