NCT02350244

Brief Summary

Evaluate the benefit of an intervention by a computer program comprising active breaks, in the form of a personalized self-program on functional impairment and / or pain, among employees with latent or symptomatic upper extremity MSDs and spine (+/- eyestrain) in connection with the computer work environment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 13, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
Last Updated

January 29, 2015

Status Verified

January 1, 2015

Enrollment Period

5 months

First QC Date

January 13, 2015

Last Update Submit

January 26, 2015

Conditions

Keywords

musculoskeletal diseaseseyestrainoccupational diseasescomputer workmuscle stretching exercisecomputer software applicationMSDs

Outcome Measures

Primary Outcomes (1)

  • Nordic style questionnaire score

    at 1 month

Secondary Outcomes (5)

  • Evolution of " Nordic style " and eyestrain questionnaires

    at 1 month

  • Evolution of global psychological status (HAD)

    at 1 month

  • Evolution of psychosocial work characteristics (VAS stress and satisfaction at work)

    at 1 month

  • Occurrence sick leave and frequency of work trips during the study.

    at 1 month

  • Adherence to the self-program

    at 1 month

Study Arms (2)

Experimental group

EXPERIMENTAL

Subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work

Behavioral: Computer program

Control group

OTHER

Control group patients had no intervention

Behavioral: Computer program

Interventions

Intervention consists in a computer program suggesting workers to take active breaks at given times of their working day, during one month.

Control groupExperimental group

Eligibility Criteria

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

You may qualify if:

  • \- To carry out a professional activity.
  • To be involved in a computer work for at least 5 hours a day.
  • To be between 18 and 65 years.

You may not qualify if:

  • \- To be in sick leave.
  • Rheumatic and neurological diseases which needed treatment.
  • Workstations which have been recently changed.
  • A behavioral and/or comprehension trouble

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

  • Lanhers C, Pereira B, Garde G, Maublant C, Dutheil F, Coudeyre E. Evaluation of 'I-Preventive': a digital preventive tool for musculoskeletal disorders in computer workers-a pilot cluster randomised trial. BMJ Open. 2016 Sep 22;6(9):e011304. doi: 10.1136/bmjopen-2016-011304.

MeSH Terms

Conditions

Musculoskeletal DiseasesAsthenopiaOccupational Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2015

First Posted

January 29, 2015

Study Start

June 1, 2014

Primary Completion

November 1, 2014

Study Completion

January 1, 2015

Last Updated

January 29, 2015

Record last verified: 2015-01

Locations