NCT03559153

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
286

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 20, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 29, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2019

Completed
Last Updated

April 17, 2019

Status Verified

April 1, 2019

Enrollment Period

1.6 years

First QC Date

April 29, 2018

Last Update Submit

April 16, 2019

Conditions

Keywords

Office workersWorker healthWork abilityMusculoskeletal disease

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (1)

  • Change from Work Ability Index (WAI) at 16 weeks

    At baseline and after 16 weeks

Study Arms (3)

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.

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.

Other: Physical Exercise

Interventions

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

Passive rest break - Shiatsu massage

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

Active rest break - Physical Exercise Program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Physical disability employees will not be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rosimeire Simprini Padula

Atibaia, São Paulo, 12942-770, Brazil

Location

MeSH Terms

Conditions

Occupational DiseasesMusculoskeletal Diseases

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Clinical Professor

Study Record Dates

First Submitted

April 29, 2018

First Posted

June 15, 2018

Study Start

June 20, 2017

Primary Completion

January 20, 2019

Study Completion

March 3, 2019

Last Updated

April 17, 2019

Record last verified: 2019-04

Locations