Musculoskeletal DiseasesWMSDNCT04192604
Work-related MusculoSkeletal Disorders Questionnaire
An observational study of Musculoskeletal Diseases and Work-Related Condition, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
Trial summary
Development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases, Work-Related Condition
- What is being tested?
- WMSDsQ
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2020to 30 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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%.
Who may be able to join
- Understanding of the Italian language
- Worker of the IRCCS Istituto Ortopedico Galeazzi
Who cannot join
- Previous surgery for musculoskeletal disorders
About this study
Official title: Development and Validation of the Work-related MusculoSkeletal Disorders Risk Assessment Questionnaire
Development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors
Read the 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.)
- Conditions
- Musculoskeletal Diseases, Work-Related Condition
- Being tested
- WMSDsQ
- Keywords
- Work-related musculoskeletal pain, pain management, prevention, screening
- Medical subject headings
- Musculoskeletal Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WMSDsQOther
Work-related MusculoSkeletal Disorders Questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and validation
Development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors
Measured: November 2019 - August 2020 (9 months)
Secondary outcomes (1)
Risk Factors
Estimation of potential work-related risk factors of WMSDs.
Measured: November 2019 - August 2020 (9 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start15 Jan 2020 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal DiseasesStudies 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
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192604
- Sponsor's protocol ID
- WMSDsQ
- Acronym
- WMSD
- Status last verified
- Nov 2019
- First submitted
- 21 Nov 2019
- Last updated
- 10 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Langella F, Vanni D, Hogh M, Palsson TS, Christensen SWM, Bellosta-Lopez P, Villafane JH, Jensen PS, Silva PB, Herrero P, Barletta P, Domenech-Garcia V, Berjano P; Prevent for Work Study Group. Development of the Prevent for Work Questionnaire (P4Wq) for the assessment of musculoskeletal risk factors in the workplace: part 2-pilot study for questionnaire development and validation. BMJ Open. 2021 Dec 24;11(12):e053988. doi: 10.1136/bmjopen-2021-053988.
PubMed 34952882
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Work-related MusculoSkeletal Disorders Risk Assessment Questionnaire
- ClinicalTrials.gov ID
- NCT04192604
- Acronym / sponsor ID
- WMSD / WMSDsQ
- Conditions
- Musculoskeletal Diseases, Work-Related Condition
- Keywords
- Work-related musculoskeletal pain, pain management, prevention, screening
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 15 Jan 2020 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 10 Dec 2019 (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.
Development and validation of a multi-factor and self-perceived risk assessment questionnaire, specifically referred to WMSDs-related pain and risk factors
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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%.
Key inclusion criteria (2 listed)
- Understanding of the Italian language
- Worker of the IRCCS Istituto Ortopedico Galeazzi
Key exclusion criteria (1 listed)
- Previous surgery for musculoskeletal disorders
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 |
|---|---|---|
| WMSDsQWork-related MusculoSkeletal Disorders Questionnaire | Other | – |
Primary outcome
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
1 secondary outcome
Risk Factors
Time frame: November 2019 - August 2020 (9 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2019.
- Derived from this study: PubMed 34952882Langella F, Vanni D, Hogh M, Palsson TS, Christensen SWM, Bellosta-Lopez P, Villafane JH, Jensen PS, Silva PB, Herrero P, Barletta P, Domenech-Garcia V, Berjano P; Prevent for Work Study Group. Development of the Prevent for Work Questionnaire (P4Wq) for the assessment of musculoskeletal risk factors in the workplace: part 2-pilot study for questionnaire development and validation. BMJ Open. 2021 Dec 24;11(12):e053988. doi: 10.1136/bmjopen-2021-053988.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Diseases and Work-Related Condition, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio.
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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and validation (time frame: November 2019 - August 2020 (9 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04192604, which also lists 1 linked publication.
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 10 Dec 2019.