- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03559153
Effect of Passive and Active Rest Break in Musculoskeletal Complains
Effect of Passive and Active Rest Break in Musculoskeletal Complains in Office Workers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Inclusion and Exclusion Criteria Office workers, who work at least 6 hours a day in a sitting position, will be included. disabled employees will not be included.
Sample size: The prevalence of complaints and pain intensity in the arm, neck and shoulder regions, in addition to the lumbar region. A statistical power of 80%, α = 5%, sample loss of 15% will be considered for the sample calculation. The reduction expected of the prevalence of musculoskeletal complaints and pain will be 20%. Therefore, it will be necessary to perform the study 286 workers, allocated in control group (CG), intervention groups (IG), passive rest break - Shiatsu - Quick massage (SGM); and comparative group using active rest break - Compensatory exercise program(CE).
the outcomes will be evaluated at the individual level, since they reflect aspects of workers' health. Data on outcome measures will be assessed at baseline and after 4 months. After a period of 4 months, the sector that received only a break or massage can receive work gymnastics, if the hypothesis of this study is confirmed on the effectiveness of the exercise on the other interventions. Both groups of workers will be followed up in a longitudinal study in subsequent months and compared to the other workers identified, within the established criteria for risk analysis, for 4 months.
Primary outcome: The occurrence of musculoskeletal symptoms (pain, tingling or numbness) will be evaluated by means of the Nordic Questionnaire for Musculoskeletal Symptoms The intensity of the pain will be evaluated by the Verbal Numerical Scale of Pain23. It is an 11-point scale, in which 0 means "no pain" and 10 means "worst possible pain".
Secondary outcomes: 1) Work ability index (WAI) to identify the worker's perception at the moment or in the near future; 2)
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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SP
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Atibaia, SP, Brazil, 12942-770
- Rosimeire Simprini Padula
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Office workers, who work at least six hours a day in a sitting position, will be included.
Exclusion Criteria:
- Physical disability employees will not be included.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
NO_INTERVENTION: Control group
All workers will receive ergonomics instructions.
Instruction for rest break.
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EXPERIMENTAL: Passive rest break - Shiatsu massage
All workers will receive ergonomics instructions.
The workers will be receive "quick massage" using shiatsu techniques.
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The shiatsu massage will be during the rest break by 15 minutes.
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ACTIVE_COMPARATOR: Active rest break - Physical Exercise Program
All workers will receive ergonomics instructions.
The workers will be receive exercises during the rest break.
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The Physical Exercise will be during the rest break by 15 minutes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Musculoskeletal complains at 4,8,12,16 weeks
Time Frame: At baseline, and after 4, 8, 12, and 16 weeks
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The occurrence of musculoskeletal symptoms (pain, tingling or numbness) will be evaluated through the Nordic Questionnaire for Musculoskeletal Symptoms (QNSO).
The interviewee will answer simple questions (yes or no) regarding the musculoskeletal symptoms he has experienced in the last 12 months and / or the last 7 days, the occurrence of functional incapacity and the demand for help from a health professional in the last 12 months resulting from these symptoms.
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At baseline, and after 4, 8, 12, and 16 weeks
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Change from Pain Intensity at 4, 8, 12, 16 weeks
Time Frame: At baseline and after 4, 8, 12, and 16 weeks
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The intensity of the pain will be evaluated by the Verbal Numerical Scale of Pain.
It is an 11-point scale, in which 0 means "no pain" and 10 means "worst possible pain".
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At baseline and after 4, 8, 12, and 16 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from Work Ability Index (WAI) at 16 weeks
Time Frame: At baseline and after 16 weeks
|
The Work Ability Index (WAI) is an instrument that evaluates the worker's perception of how well he or she is or will be at the moment or in the near future and how well he can perform his or her job, depending on the requirements, of their state of health and physical and mental capacities.
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At baseline and after 16 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1.736.249
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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