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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
116

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Brazil
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Guidelines ergonomics
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
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidade Cidade de Sao Paulo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maria Luiza Caires Comper

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 24, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18170313500000064

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