Musculoskeletal DiseasesJobrotationNCT01979731
Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders
A study testing Job rotation and Guidelines ergonomics in people with Musculoskeletal Diseases, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial summary
The objective this study is evaluated if job rotation (change works that function every to work hours)contributes to reduce absence from work to complaints musculoskeletal disorders. And: Improve general health status Improve musculoskelettal symptoms Improve work performance Decrease costs with absence Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases
- What is being tested?
- Job rotation and Guidelines ergonomics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2013to Feb 2016
- Phase
- Interventional
- 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
Who may be able to join
- Sectors workers with production lines that allow switching between different tasks and requests biomechanical exposure levels ergonomic risk. And work is carried out in production cells.
Who cannot join
- Sector workers whose production lines are automated or semi-automated, possessing the pace of work determined by machinery and that the work stoppage is not possible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders: Cluster Randomized Trial
The objective this study is evaluated if job rotation (change works that function every to work hours)contributes to reduce absence from work to complaints musculoskeletal disorders. And:
- Improve general health status
- Improve musculoskelettal symptoms
- Improve work performance
- Decrease costs with absence
Read the detailed description
This study is single-blinded RCT, whose aim is to evaluate the effect of the rotation function in the prevention of musculoskeletal disorders in industrial workers Methods: Participants will be recruited from employees a textile industry. The inclusion criteria are: employees age between 18 and 65 years and be able to read and understand the questionnaires. The number of working hours lost due to leave for sick leave due to illness of the musculoskeletal system and connective tissue (M Group International Classification of Diseases, ICD-10) is used to estimate the sample size. The average time lost during the last three months, in companies where the study was conducted is approximately 1,100 hours. Assume that interventions will enable a reduction of this number by 10%, ie, the groups will have a difference of 100 lost working hours, with a standard deviation of 250 hours. Will be considered a statistical power of 80%, α=0.05 and a follow-up loss of up to 15%. Thus, 116 workers are required per group. The productive sectors included in the study will be pre- stratified from the level of exposure to ergonomic risk factors. The sectors with similar demands will be grouped and randomly divided between the intervention group and the control group. The intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines. The control group will receive only the ergonomic guidelines. Primary outcomes: Absence from work due to sick leave due to disease of the musculoskeletal system and connective tissue. Secondary outcomes are: musculoskeletal symptoms (Nordic Questionnaire and EVA), ergonomic risk factors (Quick exposure Check and Job Factors Questionnaire), psychosocial factors and fatigue (Need for Recovery Scale (NFR), general health status (WHOQOL-bref), physical activity level (Baecke Questionnaire), productivity with Work Performance Questionnaire (HPQ) and costs (incremental cost effectiveness ratio). Outcomes will be assessed at baseline and after 3 , 6 and 12 months . The information on the amount of hours lost by removal for medical leave will be recorded daily. Expected results: It is expected that interventions to reduce the occurrence of musculoskeletal disorders and consequent worker absenteeism due to sick leave, 100 hours of work lost. It is expected that the results obtained in this study may contribute to setting standards in the field of Occupational Health, as well as for decision making of professionals working in this area.
- Conditions
- Musculoskeletal Diseases
- Being tested
- Job rotation, Guidelines ergonomics
- Keywords
- Occupational health, Ergonomics, Environments, Prevention and Control
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Job rotationOther
The intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines.
Guidelines ergonomicsOther
Orientation about manual material handling, posture, furniture, rest break and others in general.
| Study group | Role | What they receive |
|---|---|---|
| Job rotation | Experimental | The intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines. Receives: Other: Guidelines ergonomics |
| Guidelines Ergonomics | Active comparator | Manual material handling Orientation posture Orientation furniture Orientation in general Receives: Other: Job rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease musculoskeletal absence from work.
Absence from work due to sick leave due to disease of the musculoskeletal system and connective tissue
Measured: After 6 months
Secondary outcomes (1)
Decrease Musculoskeletal symptoms
Musculoskeletal symptoms (Nordic Questionnaire1 and EVA)
Measured: After 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2015
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Maria Luiza Caires Comper
- Responsible party
- Principal investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
- Investigators
- Rosimeire S Padula, PhD, Study director, Universidade Cidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01979731
- Sponsor's protocol ID
- 18170313500000064
- Acronym
- Jobrotation
- Status last verified
- Feb 2016
- First submitted
- 17 Oct 2013
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Comper ML, Padula RS. The effectiveness of job rotation to prevent work-related musculoskeletal disorders: protocol of a cluster randomized clinical trial. BMC Musculoskelet Disord. 2014 May 22;15:170. doi: 10.1186/1471-2474-15-170.
PubMed 24885958Comper MLC, Dennerlein JT, Evangelista GDS, Rodrigues da Silva P, Padula RS. Effectiveness of job rotation for preventing work-related musculoskeletal diseases: a cluster randomised controlled trial. Occup Environ Med. 2017 Aug;74(8):545-552. doi: 10.1136/oemed-2016-104077. Epub 2017 Mar 1.
PubMed 28250047
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders: Cluster Randomized Trial
- ClinicalTrials.gov ID
- NCT01979731
- Acronym / sponsor ID
- Jobrotation / 18170313500000064
- Conditions
- Musculoskeletal Diseases
- Keywords
- Occupational health, Ergonomics, Environments, Prevention and Control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Collaborators
- Maria Luiza Caires Comper
- Study start
- Sep 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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 objective this study is evaluated if job rotation (change works that function every to work hours)contributes to reduce absence from work to complaints musculoskeletal disorders. And:
- Improve general health status
- Improve musculoskelettal symptoms
- Improve work performance
- Decrease costs with absence
Detailed description
This study is single-blinded RCT, whose aim is to evaluate the effect of the rotation function in the prevention of musculoskeletal disorders in industrial workers Methods: Participants will be recruited from employees a textile industry. The inclusion criteria are: employees age between 18 and 65 years and be able to read and understand the questionnaires. The number of working hours lost due to leave for sick leave due to illness of the musculoskeletal system and connective tissue (M Group International Classification of Diseases, ICD-10) is used to estimate the sample size. The average time lost during the last three months, in companies where the study was conducted is approximately 1,100 hours. Assume that interventions will enable a reduction of this number by 10%, ie, the groups will have a difference of 100 lost working hours, with a standard deviation of 250 hours. Will be considered a statistical power of 80%, α=0.05 and a follow-up loss of up to 15%. Thus, 116 workers are required per group. The productive sectors included in the study will be pre- stratified from the level of exposure to ergonomic risk factors. The sectors with similar demands will be grouped and randomly divided between the intervention group and the control group. The intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines. The control group will receive only the ergonomic guidelines. Primary outcomes: Absence from work due to sick leave due to disease of the musculoskeletal system and connective tissue. Secondary outcomes are: musculoskeletal symptoms (Nordic Questionnaire and EVA), ergonomic risk factors (Quick exposure Check and Job Factors Questionnaire), psychosocial factors and fatigue (Need for Recovery Scale (NFR), general health status (WHOQOL-bref), physical activity level (Baecke Questionnaire), productivity with Work Performance Questionnaire (HPQ) and costs (incremental cost effectiveness ratio). Outcomes will be assessed at baseline and after 3 , 6 and 12 months . The information on the amount of hours lost by removal for medical leave will be recorded daily. Expected results: It is expected that interventions to reduce the occurrence of musculoskeletal disorders and consequent worker absenteeism due to sick leave, 100 hours of work lost. It is expected that the results obtained in this study may contribute to setting standards in the field of Occupational Health, as well as for decision making of professionals working in this area.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Job rotation | Experimental | Other: Guidelines ergonomicsThe intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines. |
| Guidelines Ergonomics | Active comparator | Other: Job rotationManual material handling Orientation posture Orientation furniture Orientation in general |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Sectors workers with production lines that allow switching between different tasks and requests biomechanical exposure levels ergonomic risk. And work is carried out in production cells.
Key exclusion criteria (1 listed)
- Sector workers whose production lines are automated or semi-automated, possessing the pace of work determined by machinery and that the work stoppage is not possible.
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 |
|---|---|---|
| Job rotationThe intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines. | Other | Guidelines Ergonomics |
| Guidelines ergonomicsOrientation about manual material handling, posture, furniture, rest break and others in general. | Other | Job rotation |
Primary outcome
Decrease musculoskeletal absence from work.
Time frame: After 6 months
Absence from work due to sick leave due to disease of the musculoskeletal system and connective tissue
1 secondary outcome
Decrease Musculoskeletal symptoms
Time frame: After 6 months
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 24 Feb 2016.
- Background: PubMed 24885958Comper ML, Padula RS. The effectiveness of job rotation to prevent work-related musculoskeletal disorders: protocol of a cluster randomized clinical trial. BMC Musculoskelet Disord. 2014 May 22;15:170. doi: 10.1186/1471-2474-15-170.
- Derived from this study: PubMed 28250047Comper MLC, Dennerlein JT, Evangelista GDS, Rodrigues da Silva P, Padula RS. Effectiveness of job rotation for preventing work-related musculoskeletal diseases: a cluster randomised controlled trial. Occup Environ Med. 2017 Aug;74(8):545-552. doi: 10.1136/oemed-2016-104077. Epub 2017 Mar 1.
- Paper ProtocolLink provided by the sponsor.
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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.
Rosimeire S Padula, PhD study director
Universidade Cidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Job rotation and Guidelines ergonomics in people with Musculoskeletal Diseases, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
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 1 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: finished, as of the sponsor's last update on 24 Feb 2016. 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 Brazil. 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?
Decrease musculoskeletal absence from work. (time frame: After 6 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 NCT01979731, which also lists 2 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 24 Feb 2016.