- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04192604
Work-related MusculoSkeletal Disorders Questionnaire (WMSD)
Development and Validation of the Work-related MusculoSkeletal Disorders Risk Assessment Questionnaire
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The World Health Organization (WHO) has defined a WMSD as one musculoskeletal disorder (MSD) that results from a number of factors, and where the work environment and the performance of the work contribute significantly, but in varying magnitude, to the causation of the disease. The term MSD denotes health problems of the musculoskeletal system, i.e. muscles, tendons, the skeleton, cartilage, the vascular system, ligaments and nerves; ranging from light and transitory disorders to disabling injuries and permanent disability, with the loss of employment. WMSDs are in general not caused by one specific, but by multiple risk factors. These include physical (e.g. manual handling of loads, working in awkward postures, repetitive work and working at high speed, exposure to vibrations) as well as psychosocial (work stress, pain believes, sleep disturbances) factors. Consequently, a holistic preventive approach is currently needed. In order to tackle WMSDs, three different levels of prevention can be used to categorise these strategies: i) primary prevention includes the risk assessment process and technical/ergonomic, organisational and person-oriented interventions; ii) secondary prevention involves the identification and health monitoring of workers at risk; and iii) tertiary prevention comprises return-to-work actions.
The answer to the WMSDs problems in companies is holistic prevention, taking into account multifactorial risks for every individual, in order to propose a tailored educational program to every worker need
The study aims to develop and validate a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors
Gathering information and collecting data on the target population and WMSDs related risk factors:
- Basic characteristics of the target populations (e.g. age, sex, work conditions etc.)
- Potential work-related risk factors (e.g. repetitive motion, static posture, etc.)
- Which of WMSDs affect more the target populations (e.g. back pain, neck pain, upper limb pain, etc.)
- Potential effects of these and related domains (quality of life, pain, number of days of absence from work etc.)
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
The sample size was set at 115 subjects. This number was established on the basis of available data deriving from surveys previously carried out in the same type of population.
The test-retest will be submitted to 20 subjects. The sample will be selected randomly from a numerical generator at intervals between 1 and n (with n = highest registration number of the center workers) among the workers of the IRCCS Istituto Ortopedico Galeazzi. Furthermore, to obtain a homogeneous distribution, the sample will be evaluated according to the type of work and according to it will be stratified into 3 categories: health workers, administrative workers, other workers. The inclusion of the subjects in each category will be interrupted when they reach 40% of the total sample. In this way, the maximum possible inhomogeneity of the sample will be 40%-40%-20%.
Description
Inclusion Criteria:
- Understanding of the Italian language
- Worker of the IRCCS Istituto Ortopedico Galeazzi
Exclusion Criteria:
- Previous surgery for musculoskeletal disorders
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development and validation
Time Frame: November 2019 - August 2020 (9 months)
|
Development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors
|
November 2019 - August 2020 (9 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Risk Factors
Time Frame: November 2019 - August 2020 (9 months)
|
Estimation of potential work-related risk factors of WMSDs.
|
November 2019 - August 2020 (9 months)
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WMSDsQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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