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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02350244
Other study ID # CHU-0219
Secondary ID
Status Completed
Phase Phase 1
First received January 13, 2015
Last updated January 26, 2015
Start date June 2014
Est. completion date January 2015

Study information

Verified date January 2015
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority France: Ministry of Health
Study type Interventional

Clinical Trial 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.


Description:

The benefit of the intervention will be assessed among four groups of subjects: symptomatic and asymptomatic subjects randomized in control or experimental group.

Subjects of the experimental group will have to follow an intervention for one month, consisting in active breaks from computer work. Control group patients had no intervention.

Symptoms of MSD will be assessed via questionnaire before and after intervention, in all groups.


Recruitment information / eligibility

Status Completed
Enrollment 200
Est. completion date January 2015
Est. primary completion date November 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- - 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.

Exclusion Criteria:

- - To be in sick leave.

- Rheumatic and neurological diseases which needed treatment.

- Workstations which have been recently changed.

- A behavioral and/or comprehension trouble

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Nordic style questionnaire score at 1 month Yes
Secondary Evolution of " Nordic style " and eyestrain questionnaires at 1 month Yes
Secondary Evolution of global psychological status (HAD) at 1 month Yes
Secondary Evolution of psychosocial work characteristics (VAS stress and satisfaction at work) at 1 month Yes
Secondary Occurrence sick leave and frequency of work trips during the study. at 1 month Yes
Secondary Adherence to the self-program at 1 month Yes