Effect of Passive and Active Rest Break in Musculoskeletal Complains
Primary Purpose
Occupational Diseases, Work-related Injury
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Shiatsu massage
Physical Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Occupational Diseases focused on measuring Office workers, Worker health, Work ability, Musculoskeletal disease
Eligibility Criteria
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.
Sites / Locations
- Rosimeire Simprini Padula
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Active Comparator
Arm Label
Control group
Passive rest break - Shiatsu massage
Active rest break - Physical Exercise Program
Arm Description
All workers will receive ergonomics instructions. Instruction for rest break.
All workers will receive ergonomics instructions. The workers will be receive "quick massage" using shiatsu techniques.
All workers will receive ergonomics instructions. The workers will be receive exercises during the rest break.
Outcomes
Primary Outcome Measures
Change from Musculoskeletal complains at 4,8,12,16 weeks
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.
Change from Pain Intensity at 4, 8, 12, 16 weeks
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".
Secondary Outcome Measures
Change from Work Ability Index (WAI) at 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.
Full Information
NCT ID
NCT03559153
First Posted
April 29, 2018
Last Updated
April 16, 2019
Sponsor
Universidade Cidade de Sao Paulo
1. Study Identification
Unique Protocol Identification Number
NCT03559153
Brief Title
Effect of Passive and Active Rest Break in Musculoskeletal Complains
Official Title
Effect of Passive and Active Rest Break in Musculoskeletal Complains in Office Workers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
June 20, 2017 (Actual)
Primary Completion Date
January 20, 2019 (Actual)
Study Completion Date
March 3, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Cidade de Sao Paulo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Work-related musculoskeletal disorders are highly disabling. Therefore, finding preventive solutions is fundamental, in order to reduce the damages to workers and society. Therefore the objective of this study will be to evaluate the effect of passive and active pauses in the control of musculoskeletal complaints of office workers. This is a randomized controlled trial by cluster, which will be performed with 286 office workers (administrative sectors). Employees with physical disabilities will not be included in the study. The workers will be distributed into three groups: active control group, and the two intervention groups massage and workout gymnastics. The active control group and the other groups will be guidelines on ergonomic adjustments of the work station, and performing a 10-minute break every 50 minutes work. The intervention groups (passive and active) will receive different interventions: group massage in the chair and group gymnastics labor. The massage will be performed 2x per week for 10 minutes, and workout 2x per week for 15-20minutes. The primary outcomes assessed will be musculoskeletal complaints of pain intensity. And as a secondary outcome will be the ability to work, perception of ergonomic risk factors, psychosocial factors and fatigue, level of physical activity. Outcomes will be assessed at baseline and after 4 months. It is expected that exercise intervention (active pause) is more effective than passive pause (massage), and that pause and guidance can reduce musculoskeletal complaints, pain intensity, and other outcomes evaluated.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Occupational Diseases, Work-related Injury
Keywords
Office workers, Worker health, Work ability, Musculoskeletal disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
All workers will receive ergonomics instructions. Instruction for rest break.
Arm Title
Passive rest break - Shiatsu massage
Arm Type
Experimental
Arm Description
All workers will receive ergonomics instructions. The workers will be receive "quick massage" using shiatsu techniques.
Arm Title
Active rest break - Physical Exercise Program
Arm Type
Active Comparator
Arm Description
All workers will receive ergonomics instructions. The workers will be receive exercises during the rest break.
Intervention Type
Other
Intervention Name(s)
Shiatsu massage
Intervention Description
The shiatsu massage will be during the rest break by 15 minutes.
Intervention Type
Other
Intervention Name(s)
Physical Exercise
Intervention Description
The Physical Exercise will be during the rest break by 15 minutes.
Primary Outcome Measure Information:
Title
Change from Musculoskeletal complains at 4,8,12,16 weeks
Description
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.
Time Frame
At baseline, and after 4, 8, 12, and 16 weeks
Title
Change from Pain Intensity at 4, 8, 12, 16 weeks
Description
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".
Time Frame
At baseline and after 4, 8, 12, and 16 weeks
Secondary Outcome Measure Information:
Title
Change from Work Ability Index (WAI) at 16 weeks
Description
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.
Time Frame
At baseline and after 16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Rosimeire Simprini Padula
City
Atibaia
State/Province
SP
ZIP/Postal Code
12942-770
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Effect of Passive and Active Rest Break in Musculoskeletal Complains
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