|- candidate number||0|
|- NTR Number||NTR44|
|- Date ISRCTN created||5-aug-2005|
|- date ISRCTN requested||18-jul-2005|
|- Date Registered NTR||24-jun-2005|
|- Secondary IDs||N/A |
|- Public Title||The Computer Automated Pause Software (CAPS) study, randomised controlled trial in the effectiveness of pause software in VDU workers.|
|- 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|
|- Healt Condition(s) or Problem(s) studied||Complaints of Arm, Neck and Shoulders (CANS), Non-specific pain of the upper extremities, Repetitive Strain Injury (RSI), Neck complaints, Complaints of shoulder|
|- 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. |
|- Exclusion criteria||All other than the inclusion criteria.|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||22-aug-2005|
|- planned closingdate||28-feb-2007|
|- Target number of participants||600|
|- Interventions||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.
|- Primary outcome||Main outcomes are prevalence and incidence of RSI risk factors and complaints. A worker will be defined as a RSI case in case 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). Duration of computer use will be registered with WorkPace registration software. 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 in will be evaluated by the worker on an 11-pointnumerical scale ranging from 0 (no pain) to 10 (as much as can be imagined).|
|- Secondary outcome||Data on costs will be gathered from several sources. Data on sick leave will be gathered from the companies registration Direct costs (visits to the general practitioner etc) due to upper limb musculoskeletal disorders will be gathered by questionnaire. Data on productivity will be collected by registering the amount of processed claims.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES|| Eline M. Meijer|
|- CONTACT for SCIENTIFIC QUERIES|| Eline M. Meijer|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Coronel Institute for Occupational and Environmental Health|
(Source(s) of Monetary or Material Support)
|Ministry of Social affairs and Employment|
|- Brief summary||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.
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 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 VDU workers that do not have break software to their disposal?
|- Main changes (audit trail)|
|- RECORD||14-jul-2005 - 16-nov-2009|