Occupational DiseasesNCT03559153
Effect of Passive and Active Rest Break in Musculoskeletal Complains
A study testing Shiatsu massage and Physical Exercise in people with Occupational Diseases and Work-related Injury, run by Universidade Cidade de Sao Paulo at 1 site in Brazil.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Occupational Diseases, Work-related Injury
- What is being tested?
- Shiatsu massage and Physical Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 286 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jun 2017to 3 Mar 2019
- 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
- Office workers, who work at least six hours a day in a sitting position, will be included.
Who cannot join
- Physical disability employees will not be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Passive and Active Rest Break in Musculoskeletal Complains in Office Workers
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.
Read the 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)
- Conditions
- Occupational Diseases, Work-related Injury
- Being tested
- Shiatsu massage, Physical Exercise
- Keywords
- Office workers, Worker health, Work ability, Musculoskeletal disease
- Medical subject headings
- Occupational Diseases, Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shiatsu massageOther
The shiatsu massage will be during the rest break by 15 minutes.
Physical ExerciseOther
The Physical Exercise will be during the rest break by 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | All workers will receive ergonomics instructions. Instruction for rest break. |
| Passive rest break - Shiatsu massage | Experimental | All workers will receive ergonomics instructions. The workers will be receive "quick massage" using shiatsu techniques. Receives: Other: Shiatsu massage |
| Active rest break - Physical Exercise Program | Active comparator | All workers will receive ergonomics instructions. The workers will be receive exercises during the rest break. Receives: Other: Physical Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline, and after 4, 8, 12, and 16 weeks
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".
Measured: At baseline and after 4, 8, 12, and 16 weeks
Secondary outcomes (1)
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.
Measured: At baseline and after 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start20 Jun 2017
- Primary completion20 Jan 2019
- Study completion3 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational DiseasesStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 286 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Cidade de Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rosimeire Simprini Padula, Universidade Cidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559153
- Sponsor's protocol ID
- 1.736.249
- Status last verified
- Apr 2019
- First submitted
- 29 Apr 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Passive and Active Rest Break in Musculoskeletal Complains in Office Workers
- ClinicalTrials.gov ID
- NCT03559153
- Acronym / sponsor ID
- 1.736.249
- Conditions
- Occupational Diseases, Work-related Injury
- Keywords
- Office workers, Worker health, Work ability, Musculoskeletal disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 286 participants (actual)
- Lead sponsor
- Universidade Cidade de Sao PauloUniversity, hospital or other
- Study start
- 20 Jun 2017 (actual)
- Primary completion
- 20 Jan 2019 (actual)
- Study completion
- 3 Mar 2019 (actual)
- First posted
- 15 Jun 2018 (actual)
- 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.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –All workers will receive ergonomics instructions. Instruction for rest break. |
| Passive rest break - Shiatsu massage | Experimental | Other: Shiatsu massageAll workers will receive ergonomics instructions. The workers will be receive "quick massage" using shiatsu techniques. |
| Active rest break - Physical Exercise Program | Active comparator | Other: Physical ExerciseAll workers will receive ergonomics instructions. The workers will be receive exercises during the rest break. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Office workers, who work at least six hours a day in a sitting position, will be included.
Key exclusion criteria (1 listed)
- Physical disability employees will not be included.
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 |
|---|---|---|
| Shiatsu massageThe shiatsu massage will be during the rest break by 15 minutes. | Other | Passive rest break - Shiatsu massage |
| Physical ExerciseThe Physical Exercise will be during the rest break by 15 minutes. | Other | Active rest break - Physical Exercise Program |
Primary outcome
Change from Musculoskeletal complains at 4,8,12,16 weeks
Time frame: At baseline, and after 4, 8, 12, and 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
Time frame: At baseline and after 4, 8, 12, and 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".
1 secondary outcome
Change from Work Ability Index (WAI) at 16 weeks
Time frame: At baseline and after 16 weeks
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 17 Apr 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shiatsu massage and Physical Exercise in people with Occupational Diseases and Work-related Injury, run by Universidade Cidade de Sao Paulo 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 17 Apr 2019. 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?
Change from Musculoskeletal complains at 4,8,12,16 weeks (time frame: At baseline, and after 4, 8, 12, and 16 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.