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 measure
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 (if study stopped)
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
Total final enrolment
354
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
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
Basic results (scientific)
Publication list
2009 results in: https://www.ncbi.nlm.nih.gov/pubmed/19028805 (added 04/06/2019)