The Computer Automated Pause Software (CAPS) study: randomised controlled trial in the effectiveness of pause software in VDU workers

ISRCTN	ISRCTN13222474
DOI	https://doi.org/10.1186/ISRCTN13222474
Protocol serial number	NTR44
Sponsor	Academic Medical Center (AMC) (The Netherlands)
Funder	The Ministry of Social Affairs and Employment (The Netherlands)

Submission date: 04/08/2005
Registration date: 04/08/2005
Last edited: 04/06/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr E M Meijer
Scientific

Academic Medical Center (AMC)
Coronel Institute for Occupational and Environmental Health
P.O. Box 22660
Meibergdreef 9
Amsterdam
1100 DE
Netherlands

Phone	+31 (0)20 566 2799
Email	e.m.meijer@amc.uva.nl

Study information

Primary study design	Interventional
Study design	Randomised, single-blinded, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
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
Study acronym	CAPS study
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	28/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	600
Total final enrolment	354
Key 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.
Key exclusion criteria	All other than the inclusion criteria.
Date of first enrolment	22/08/2005
Date of final enrolment	28/02/2007

Locations

Countries of recruitment

Netherlands

Study participating centre

Academic Medical Center (AMC)

Amsterdam
1100 DE
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2009	04/06/2019	Yes	No

Editorial Notes

04/06/2019: Total final enrolment and publication reference were added.