CClinicalTrials.gg
Status unknownNCT04192604WMSDUpdated Dec 10, 2019

Work-related MusculoSkeletal Disorders Questionnaire

An observational study in Musculoskeletal Diseases and Work-Related Condition, sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio. Status unknown. Per ClinicalTrials.gov, last updated 2019-12-10.

Sponsored by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Observational

The sponsor has not verified this record recently (last verified Nov 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
115
Sex
All
01

Study summary

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.)
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Conditions studied

  • Musculoskeletal Diseases
  • Work-Related Condition

Keywords

  • Work-related musculoskeletal pain
  • pain management
  • prevention
  • screening
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In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's planned enrollment of 115 is close to the median of 126 across 201 observational studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio is the lead sponsor of 157 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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%.

Inclusion criteria

  • Understanding of the Italian language
  • Worker of the IRCCS Istituto Ortopedico Galeazzi

Exclusion criteria

Exclusion Criteria:

  • Previous surgery for musculoskeletal disorders
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
115 participants (estimated)
Patient registry
No

Interventions

  • OtherWMSDsQ

    Work-related MusculoSkeletal Disorders Questionnaire

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: November 2019 - August 2020 (9 months)

Secondary outcomes

  1. Risk Factors

    Estimation of potential work-related risk factors of WMSDs.

    Time frame: November 2019 - August 2020 (9 months)

07

Study locations

No study locations are listed for this record.

08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04192604
Lead sponsor
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Responsible party
Sponsor
First posted
Dec 10, 2019
Start date
Jan 15, 2020 (estimated)
Primary completion
Aug 30, 2020 (estimated)
Completion
Nov 30, 2020 (estimated)
Last update
Dec 10, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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