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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01979731
Other study ID # 18170313500000064
Secondary ID
Status Completed
Phase N/A
First received October 17, 2013
Last updated February 23, 2016
Start date September 2013
Est. completion date February 2016

Study information

Verified date February 2016
Source Universidade Cidade de Sao Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics CommitteeBrazil: National Committee of Ethics in Research
Study type Interventional

Clinical 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date February 2016
Est. primary completion date February 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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.
Guidelines ergonomics
Orientation about manual material handling, posture, furniture, rest break and others in general.

Locations

Country Name City State
Brazil Rosimeire Simprini Padula Atibaia SP

Sponsors (2)

Lead Sponsor Collaborator
Universidade Cidade de Sao Paulo Maria Luiza Caires Comper

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Change Geral Health Condictions Psychosocial factors and fatigue (Need for Recovery Scale (NFR), general health status (WHOQOL-bref), physical activity level (Baecke Questionnaire) After 6 months Yes
Other Reduced Cost effectiveness Productivity (Work Performance Questionnaire (HPQ) and costs (incremental cost effectiveness ratio). After 6 months Yes
Primary Decrease musculoskeletal absence from work. Absence from work due to sick leave due to disease of the musculoskeletal system and connective tissue After 6 months No
Secondary Decrease Musculoskeletal symptoms Musculoskeletal symptoms (Nordic Questionnaire1 and EVA) After 6 months No
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