Occupational Musculoskeletal DisordersNCT00874718
Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers
A study testing educational program and General education in people with Occupational Musculoskeletal Disorders and Healthy, run by Federal University of Rio Grande do Sul at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Musculoskeletal Disorders, Healthy
- What is being tested?
- educational program and General education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Mar 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All workers from a specific company, including administrative and production sections.
Who cannot join
- Workers absent from the workplace during all the study period.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers.
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.
- Conditions
- Occupational Musculoskeletal Disorders, Healthy
- Being tested
- educational program, General education
- Keywords
- repetitive strain injury, quality of life, functional capacity, workers
- Medical subject headings
- Cumulative Trauma Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational programBehavioural
6-week educational program for prevention of occupational musculoskeletal diseases.
General educationBehavioural
Non-specific educational program for general health.
| Study group | Role | What they receive |
|---|---|---|
| Action group | Active comparator | Not described Receives: Behavioral: educational program |
| Control group | Other | Non-specific educational program for general health. Receives: Behavioral: General education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Outcomes Study 36-Item Short Form Health Survey - (SF-36)
Measured: 6 months
Secondary outcomes (2)
Work Limitation Questionnaire
Measured: 6 months
Work absenteeism
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2009 (estimated)
- Study startOct 2007
- Primary completionAug 2008
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational Musculoskeletal DisordersStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Rio Grande do Sul
- Sponsor type
- University, hospital or other
- Investigators
- Ricardo M Xavier, MD, Study director, Associate ProfessorAntonio C dos Santos, MD, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00874718
- Sponsor's protocol ID
- 2007755
- Status last verified
- Mar 2009
- First submitted
- 31 Mar 2009
- Last updated
- 2 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21276217
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact in Life Quality of a Educational Program for Prevention of Occupational Musculoskeletal Disorders in Workers.
- ClinicalTrials.gov ID
- NCT00874718
- Acronym / sponsor ID
- 2007755
- Conditions
- Occupational Musculoskeletal Disorders, Healthy
- Keywords
- repetitive strain injury, quality of life, functional capacity, workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Federal University of Rio Grande do SulUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 2 Apr 2009 (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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Action group | Active comparator | Behavioral: educational program |
| Control group | Other | Behavioral: General educationNon-specific educational program for general health. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All workers from a specific company, including administrative and production sections.
Key exclusion criteria (1 listed)
- Workers absent from the workplace during all the study period.
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 |
|---|---|---|
| educational program6-week educational program for prevention of occupational musculoskeletal diseases. | Behavioural | Action group |
| General educationNon-specific educational program for general health. | Behavioural | Control group |
Primary outcome
Medical Outcomes Study 36-Item Short Form Health Survey - (SF-36)
Time frame: 6 months
2 secondary outcomes
Work Limitation Questionnaire
Time frame: 6 months
Work absenteeism
Time frame: 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 2 Apr 2009.
- Derived from this study: PubMed 21276217Santos 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.
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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.
Ricardo M Xavier, MD study director
Associate Professor
Antonio C dos Santos, MD principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational program and General education in people with Occupational Musculoskeletal Disorders and Healthy, run by Federal University of Rio Grande do Sul 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 2 Apr 2009. 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?
Medical Outcomes Study 36-Item Short Form Health Survey - (SF-36) (time frame: 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 NCT00874718, which also lists 1 linked publication.
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 2 Apr 2009.