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临床试验/NCT03559153
NCT03559153已完成不适用

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

Universidade Cidade de Sao Paulo2 个研究点 分布在 1 个国家目标入组 286 人开始时间: 2017年6月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
286
试验地点
2
主要终点
Change from Pain Intensity at 4, 8, 12, 16 weeks

研究概览

简要总结

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.

详细描述

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)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Office workers, who work at least six hours a day in a sitting position, will be included.

排除标准

  • Physical disability employees will not be included.

研究组 & 干预措施

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.

干预措施: Shiatsu massage (Other)

Active rest break - Physical Exercise Program

Active Comparator

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

干预措施: Physical Exercise (Other)

结局指标

主要结局

Change from Pain Intensity at 4, 8, 12, 16 weeks

时间窗: 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".

Change from Musculoskeletal complains at 4,8,12,16 weeks

时间窗: 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.

次要结局

  • Change from Work Ability Index (WAI) at 16 weeks(At baseline and after 16 weeks)

研究者

发起方
Universidade Cidade de Sao Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

Rosimeire Simprini Padula

PhD. Clinical Professor

Universidade Cidade de Sao Paulo

研究点 (2)

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