Effect of Passive and Active Rest Break in Musculoskeletal Complains

Occupational Diseases Clinical Trial

Official title:

Effect of Passive and Active Rest Break in Musculoskeletal Complains in Office Workers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03559153
• Other study ID #: 1.736.249
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: March 3, 2019

Study information

• Verified date: April 2019
• Source: Universidade Cidade de Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 286
• Est. completion date: March 3, 2019
• Est. primary completion date: January 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Occupational Diseases
• Work-related Injury

Intervention

Other:
• Shiatsu massage
The shiatsu massage will be during the rest break by 15 minutes.
• Physical Exercise
The Physical Exercise will be during the rest break by 15 minutes.

Locations

Country	Name	City	State
Brazil	Rosimeire Simprini Padula	Atibaia	SP

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Cidade de Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At baseline, and after 4, 8, 12, and 16 weeks
Primary	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".	At baseline and after 4, 8, 12, and 16 weeks
Secondary	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.	At baseline and after 16 weeks