Condition category
Injury, Occupational Diseases, Poisoning
Date applied
04/08/2005
Date assigned
04/08/2005
Last edited
10/06/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr E M Meijer

ORCID ID

Contact details

Academic Medical Center (AMC)
Coronel Institute for Occupational and Environmental Health
P.O. Box 22660
Meibergdreef 9
Amsterdam
1100 DE
Netherlands
+31 (0)20 566 2799
e.m.meijer@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR44

Study information

Scientific title

The Computer Automated Pause Software (CAPS) study: randomised controlled trial in the effectiveness of pause software in VDU workers for prevention of work related upper extremity complaints

Acronym

CAPS study

Study hypothesis

Complaints of arm, neck, shoulders, non-specific pain of the upper extremities, repetitive strain injury (RSI).

The aim of this study is twofold: on the one hand to investigate whether use of break software reduces risk factors in VDU work and on the other hand whether RSI complaints are prevented and reduced.

Research questions:
1. Does the use of break software lead to a reduction of RSI risk factors in VDU workers, compared to not using break software?
2. Does efficient use of break software lead to prevention of RSI complaints in VDU workers compared to VDU workers that do not have break software to their disposal?
3. Does efficient use of break software lead to a reduction of existing RSI complaints in VDU workers compared to VDU workers that do not have break software to their disposal?

Ethics approval

Not provided at time of registration

Study design

Randomised, single-blinded, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Repetitive strain injury (RSI)

Intervention

The intervention group will have break software at their disposal in an active way: they will know how to set up and use the software and will have background information on the possible benefits of the break software.

The control group will not have break software at their disposal.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Main outcomes are prevalence and incidence of RSI risk factors and complaints. A worker will be defined as an RSI case if symptoms are present on at least 4 days during at least 1 week in the last 12 months. Symptoms have to be present in one or more of the upper extremity body regions: neck, upper back, shoulder, elbow, forearm, wrist and/or hand (SALTSA definition).
2. Duration of computer use will be registered with WorkPace registration software
3. Complaints will be measured with the QuickDASH questionnaire. Pain and complaints in the previous 24 hours will be measured with a Visual Analogue Scale. The average pain intensity will be evaluated by the worker on an 11-point numerical scale ranging from 0 (no pain) to 10 (as much as can be imagined).

Secondary outcome measures

1. Data on costs will be gathered from several sources
2. Data on sick leave will be gathered from the company's registration
3. Direct costs (visits to the general practitioner etc.) due to upper limb musculoskeletal disorders will be gathered by questionnaire
4. Data on productivity will be collected by registering the amount of processed claims

Overall trial start date

22/08/2005

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Workers with at least 4 hours of VDU work per day. In light of the prevalence of complaints, a maximum of 40% of the included workers will have (or will have had) RSI complaints.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

600

Participant exclusion criteria

All other than the inclusion criteria.

Recruitment start date

22/08/2005

Recruitment end date

28/02/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academic Medical Center (AMC)
Amsterdam
1100 DE
Netherlands

Sponsor information

Organisation

Academic Medical Center (AMC) (The Netherlands)

Sponsor details

Coronel Institute for Occupational and Environmental Health
P.O. Box 22700
Amsterdam
1100 DE
Netherlands
+31 (0)20 566 2831
i.a.steenstra@amc.uva.nl

Sponsor type

University/education

Website

http://www.amc.nl

Funders

Funder type

Government

Funder name

The Ministry of Social Affairs and Employment (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes