Effect of Passive and Active Rest Break in Musculoskeletal Complains

NCT ID: NCT03559153

Last Updated: 2019-04-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 286 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2019-03-03

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)

Conditions

Occupational Diseases; Work-related Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Control group

All workers will receive ergonomics instructions. Instruction for rest break.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Passive rest break - Shiatsu massage

All workers will receive ergonomics instructions. The workers will be receive "quick massage" using shiatsu techniques.

Group Type: EXPERIMENTAL

Shiatsu massage

Intervention Type: OTHER

The shiatsu massage will be during the rest break by 15 minutes.

Active rest break - Physical Exercise Program

All workers will receive ergonomics instructions. The workers will be receive exercises during the rest break.

Group Type: ACTIVE_COMPARATOR

Physical Exercise

Intervention Type: OTHER

The Physical Exercise will be during the rest break by 15 minutes.

Interventions

Shiatsu massage

The shiatsu massage will be during the rest break by 15 minutes.

Intervention Type: OTHER

Physical Exercise

The Physical Exercise will be during the rest break by 15 minutes.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Cidade de Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Rosimeire Simprini Padula

PhD. Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Rosimeire Simprini Padula

Atibaia, São Paulo, Brazil

Countries

Brazil

Other Identifiers

1.736.249

Identifier Type: -

Identifier Source: org_study_id