- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01979731
Effects Job Rotation in the Prevention of Work Related Musculoskeletal Disorders (Jobrotation)
February 23, 2016 updated by: Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
SP
-
Atibaia, SP, Brazil, 12942-770
- Rosimeire Simprini Padula
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Job rotation
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.
|
Orientation about manual material handling, posture, furniture, rest break and others in general.
|
|
Active Comparator: Guidelines Ergonomics
Manual material handling Orientation posture Orientation furniture Orientation in general
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
After 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decrease Musculoskeletal symptoms
Time Frame: After 6 months
|
Musculoskeletal symptoms (Nordic Questionnaire1 and EVA)
|
After 6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change Geral Health Condictions
Time Frame: After 6 months
|
Psychosocial factors and fatigue (Need for Recovery Scale (NFR), general health status (WHOQOL-bref), physical activity level (Baecke Questionnaire)
|
After 6 months
|
|
Reduced Cost effectiveness
Time Frame: After 6 months
|
Productivity (Work Performance Questionnaire (HPQ) and costs (incremental cost effectiveness ratio).
|
After 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Rosimeire S Padula, PhD, Universidade Cidade de Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Comper 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
February 1, 2015
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
October 17, 2013
First Submitted That Met QC Criteria
November 3, 2013
First Posted (Estimate)
November 8, 2013
Study Record Updates
Last Update Posted (Estimate)
February 24, 2016
Last Update Submitted That Met QC Criteria
February 23, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18170313500000064
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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