NCT00874718

Brief Summary

The study consists of evaluating the efficacy of an Educational Program for prevention of occupational musculoskeletal problems in workers. It is a randomized clinical trial with parallel groups and blinded evaluator, with a control group not submitted to the educational program, but that received a program for general orientation in health. The primary outcome was the change of the quality of life measured by means of Medical Outcomes Study 36-Term Short Health Survey (SF-36), that it is a generic instrument of evaluation of the quality of life, translated and validated in Portuguese of Brazil.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
Last Updated

April 2, 2009

Status Verified

March 1, 2009

Enrollment Period

10 months

First QC Date

March 31, 2009

Last Update Submit

April 1, 2009

Conditions

Occupational Musculoskeletal DisordersHealthy

Keywords

repetitive strain injuryquality of lifefunctional capacityworkers

Outcome Measures

Primary Outcomes (1)

  • Medical Outcomes Study 36-Item Short Form Health Survey - (SF-36)

    6 months

Secondary Outcomes (2)

  • Work Limitation Questionnaire

    6 months

  • Work absenteeism

    6 months

Study Arms (2)

Action group

ACTIVE COMPARATOR
Behavioral: educational program

Control group

OTHER

Non-specific educational program for general health.

Behavioral: General education

Interventions

educational programBEHAVIORAL

6-week educational program for prevention of occupational musculoskeletal diseases.

Action group
General educationBEHAVIORAL

Non-specific educational program for general health.

Control group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All workers from a specific company, including administrative and production sections.

You may not qualify if:

  • Workers absent from the workplace during all the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

  • Santos AC, Bredemeier M, Rosa KF, Amantea VA, Xavier RM. Impact on the Quality of Life of an Educational Program for the Prevention of Work-Related Musculoskeletal Disorders: a randomized controlled trial. BMC Public Health. 2011 Jan 28;11:60. doi: 10.1186/1471-2458-11-60.

    PMID: 21276217DERIVED

MeSH Terms

Conditions

Cumulative Trauma Disorders

Condition Hierarchy (Ancestors)

Sprains and StrainsWounds and Injuries

Study Officials

  • Ricardo M Xavier, MD

    Associate Professor

    STUDY DIRECTOR

  • Antonio C dos Santos, MD

    Associate Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

October 1, 2007

Primary Completion

August 1, 2008

Study Completion

March 1, 2009

Last Updated

April 2, 2009

Record last verified: 2009-03

Locations

BR(1)