Musculoskeletal PainNCT04342208
Evaluate the Working Environments of Individuals Working From Home During Covid-19 Outbreak
An observational study of Musculoskeletal Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The study aims to evaluate the working environments of individuals working from home during the covid-19 outbreak and the effect of the working environments on their musculoskeletal system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Pain
- How many people
- 259 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2020to 1 Aug 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will include people between the ages of 18-65 who works from home (works in the office before isolation) as a part of Covid-19 isolation measure
Who may be able to join
- between the ages of 18-65
- works from home
- works in the office before isolation
Who cannot join
- have any systemic disease that may affect on musculoskeletal system such as fibromyalgia, myofacial pain syndrome, etc.
- have any vision problem
- have difficulty of understanding and following online survey
- have any physical disability
- have self-reported computer use for less than four hours on a typical workday
Trial locations and contacts
1 site in 1 country.
About this study
The study aims to evaluate the working environments of individuals working from home during the covid-19 outbreak and the effect of the working environments on their musculoskeletal system.
Read the detailed description
The study will include people between the ages of 18-65 who work from home (works in the office before isolation) as a part of the Covid-19 isolation measure. The working environment of the individuals participating in the study will be evaluated with The Rapid Office Strain Assessment (ROSA). Musculoskeletal symptoms will be analyzed by using the Standardised Nordic Questionnaires (NMQ). Pain will be analyzed by using the Visual Analogue Scale (VAS) .
- Conditions
- Musculoskeletal Pain
- Medical subject headings
- Musculoskeletal Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
The Rapid Office Strain Assessment (ROSA)
The working environment of the individuals participating in the study will be evaluated with The Rapid Office Strain Assessment (ROSA). ROSA is a picture-based posture checklist designed to quantify exposure to risk factors in an office work environment. In ROSA, three subsections (A-chair height, depth, armrest, and backrest; B-monitor and telephone; C-mouse and keyboard) of the office work environment are assessed. After completing the ROSA checklist, the related tables are used to calculate the score from each part, and eventually, the final ROSA score is derived. If the final score is ≤4; the risk of musculoskeletal disorders is low (low risky). If the final score is ≥5 the risk of musculoskeletal disorders risk is high (high risky).
Measured: 30 minutes
Secondary outcomes (1)
The Standardised Nordic Questionnaries (NMQ)
The NMQ includes 27 items exploring the presence of musculoskeletal symptoms for the last 12 months covering nine different parts of the body. It also has items about severity grades, determined according to functional status and the presence of musculoskeletal symptoms during the 7 days. Symptoms indicate musculoskeletal disorders in different body regions among the working population. The NMQ section that questions the last 7 days will be used in the study. In that section consists additional questions relating to the neck, the shoulders, and the lower back further detail relevant issues. Twenty-five forced-choice questions elicit any accidents affecting each area, functional impact at home and work (change of job or duties), duration of the problem, assessment by a health professional, and musculoskeletal problems in the last 7 days.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start29 May 2020
- Primary completion1 Jul 2020
- Study completion1 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 259 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Polen Akşimşek, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Zengin Alpözgen, PhD, Study director, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04342208
- Sponsor's protocol ID
- GPA1347
- Status last verified
- Feb 2022
- First submitted
- 7 Apr 2020
- Last updated
- 4 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Barbieri DF, Srinivasan D, Mathiassen SE, Oliveira AB. Variation in upper extremity, neck and trunk postures when performing computer work at a sit-stand station. Appl Ergon. 2019 Feb;75:120-128. doi: 10.1016/j.apergo.2018.09.012. Epub 2018 Oct 3.
PubMed 30509516Brewer S, Van Eerd D, Amick BC 3rd, Irvin E, Daum KM, Gerr F, Moore JS, Cullen K, Rempel D. Workplace interventions to prevent musculoskeletal and visual symptoms and disorders among computer users: a systematic review. J Occup Rehabil. 2006 Sep;16(3):325-58. doi: 10.1007/s10926-006-9031-6.
PubMed 16933148Sonne M, Villalta DL, Andrews DM. Development and evaluation of an office ergonomic risk checklist: ROSA--rapid office strain assessment. Appl Ergon. 2012 Jan;43(1):98-108. doi: 10.1016/j.apergo.2011.03.008. Epub 2011 May 6.
PubMed 21529772Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
PubMed 15676628Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.
PubMed 12858463Kahraman T, Genc A, Goz E. The Nordic Musculoskeletal Questionnaire: cross-cultural adaptation into Turkish assessing its psychometric properties. Disabil Rehabil. 2016 Oct;38(21):2153-60. doi: 10.3109/09638288.2015.1114034. Epub 2016 Jan 4.
PubMed 26726840
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Working Environments of Individuals Working From Home During Covid-19 Outbreak
- ClinicalTrials.gov ID
- NCT04342208
- Acronym / sponsor ID
- GPA1347
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 259 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 29 May 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 10 Apr 2020 (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 study aims to evaluate the working environments of individuals working from home during the covid-19 outbreak and the effect of the working environments on their musculoskeletal system.
Detailed description
The study will include people between the ages of 18-65 who work from home (works in the office before isolation) as a part of the Covid-19 isolation measure. The working environment of the individuals participating in the study will be evaluated with The Rapid Office Strain Assessment (ROSA). Musculoskeletal symptoms will be analyzed by using the Standardised Nordic Questionnaires (NMQ). Pain will be analyzed by using the Visual Analogue Scale (VAS) .
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include people between the ages of 18-65 who works from home (works in the office before isolation) as a part of Covid-19 isolation measure
Key inclusion criteria (3 listed)
- between the ages of 18-65
- works from home
- works in the office before isolation
Key exclusion criteria (5 listed)
- have any systemic disease that may affect on musculoskeletal system such as fibromyalgia, myofacial pain syndrome, etc.
- have any vision problem
- have difficulty of understanding and following online survey
- have any physical disability
- have self-reported computer use for less than four hours on a typical workday
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The Rapid Office Strain Assessment (ROSA)
Time frame: 30 minutes
The working environment of the individuals participating in the study will be evaluated with The Rapid Office Strain Assessment (ROSA). ROSA is a picture-based posture checklist designed to quantify exposure to risk factors in an office work environment. In ROSA, three subsections (A-chair height, depth, armrest, and backrest; B-monitor and telephone; C-mouse and keyboard) of the office work environment are assessed. After completing the ROSA checklist, the related tables are used to calculate the score from each part, and eventually, the final ROSA score is derived. If the final score is ≤4; the risk of musculoskeletal disorders is low (low risky). If the final score is ≥5 the risk of musculoskeletal disorders risk is high (high risky).
1 secondary outcome
The Standardised Nordic Questionnaries (NMQ)
Time frame: 15 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2022.
- Background: PubMed 30509516Barbieri DF, Srinivasan D, Mathiassen SE, Oliveira AB. Variation in upper extremity, neck and trunk postures when performing computer work at a sit-stand station. Appl Ergon. 2019 Feb;75:120-128. doi: 10.1016/j.apergo.2018.09.012. Epub 2018 Oct 3.
- Background: PubMed 16933148Brewer S, Van Eerd D, Amick BC 3rd, Irvin E, Daum KM, Gerr F, Moore JS, Cullen K, Rempel D. Workplace interventions to prevent musculoskeletal and visual symptoms and disorders among computer users: a systematic review. J Occup Rehabil. 2006 Sep;16(3):325-58. doi: 10.1007/s10926-006-9031-6.
- Background: PubMed 21529772Sonne M, Villalta DL, Andrews DM. Development and evaluation of an office ergonomic risk checklist: ROSA--rapid office strain assessment. Appl Ergon. 2012 Jan;43(1):98-108. doi: 10.1016/j.apergo.2011.03.008. Epub 2011 May 6.
- Background: PubMed 15676628Kuorinka I, Jonsson B, Kilbom A, Vinterberg H, Biering-Sorensen F, Andersson G, Jorgensen K. Standardised Nordic questionnaires for the analysis of musculoskeletal symptoms. Appl Ergon. 1987 Sep;18(3):233-7. doi: 10.1016/0003-6870(87)90010-x.
- Background: PubMed 12858463Clark P, Lavielle P, Martinez H. Learning from pain scales: patient perspective. J Rheumatol. 2003 Jul;30(7):1584-8.
- Background: PubMed 26726840Kahraman T, Genc A, Goz E. The Nordic Musculoskeletal Questionnaire: cross-cultural adaptation into Turkish assessing its psychometric properties. Disabil Rehabil. 2016 Oct;38(21):2153-60. doi: 10.3109/09638288.2015.1114034. Epub 2016 Jan 4.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Ayşe Zengin Alpözgen, PhD study director
Istanbul University - Cerrahpasa
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 Musculoskeletal Pain, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 4 Mar 2022. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The Rapid Office Strain Assessment (ROSA) (time frame: 30 minutes). 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 NCT04342208, which also lists 6 linked publications.
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 4 Mar 2022.