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ISRCTN
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ISRCTN40949689
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ClinicalTrials.gov identifier
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Public title
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Cost-effectiveness of an individual on line real-life computer-tailored physical activity and educational intervention at work-site to secondary prevention of non-specific sub acute or recurrent low back pain on office workers: "Look after your back"
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Scientific title
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Cost-effectiveness of an individual on line real-life computer-tailored physical activity and educational intervention at work-site to secondary prevention of non-specific sub acute and recurrent low back pain in office workers: blinded randomised controlled trial
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Acronym
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CTE project
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Serial number at source
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N/A
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Study hypothesis
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1. An individual on line real-life computer-tailored physical activity and educational intervention at work-site with e-mail reminder will prevent moderate low-back pain on office workers
2. An individual on line real-life computer-tailored physical activity and educational intervention at work-site with e-mail reminder will reduce the risk of disability in patients with low back pain
3.An individual on line real-life computer-tailored physical activity and educational intervention at work-site with e-mail reminder will improve the quality of life n patients with low back pain
4. An individual on line real-life computer-tailored physical activity and educational intervention at work-site with e-mail reminder is a cost-effective addition to usual care in patients with low back pain
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Lay summary
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Ethics approval
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Biomedical Ethical Committee of the University of Extremadura approved on the 16th June 2010 (ref: 32/2010)
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Study design
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Blinded randomised controlled trial
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Countries of recruitment
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Spain
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Disease/condition/study domain
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Non-specific low back pain
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Participants - inclusion criteria
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1. Workers (aged 18 - 65 years, either sex) with subacute non-specific low back pain
2. Patient assessed by Preventive Medicine Services from University of Extremadura
3. Working with a computer and internet access at work
4. Informed consent
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Participants - exclusion criteria
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1. Other major disease
2. Regular physical activity more than one day a week in the last 5 years
3. Any drug intake that may affect back pain significantly - to avoid external influences
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Anticipated start date
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16/06/2010
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Anticipated end date
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17/02/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100
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Interventions
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The participants will be randomly assigned to intervention or control group by a random table built by computer:
1. Interventional group: eight-month individual online real-life computer-tailored physical activity and educational intervention at work-site with an e-mail reminder
2. Control group: eight-month individual online real-life computer-tailored physical activity and educational intervention at work-site without a e-mail reminder
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Primary outcome measure(s)
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Measured at baseline, three months and eight months:
1. Socio-sanitary costs (direct and indirects costs)
2. Functional and psychological disability in nonspecific low back pain (using Roland-Morris Questionnaire, the Oswestry Disability Index and the Start Back Tool [SBST])
3. Health-related quality of life (using the EuroQoL questionnaire [EQ-5D]) and their utilities to health economic analyses
4. Fitness and muscular function (using the handgrip strength test, Ito-Shirado and leg and back flexibility)
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Secondary outcome measure(s)
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1. Grade of satisfaction with programme
2. International Physical Activity Questionnaire (IPAQ)
3. Stage of change
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Sources of funding
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University of Extremadura (Spain)
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Trial website
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Publications
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Contact name
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Prof
Narcis
Gusi
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Address
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Avda Universidad s/n
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City/town
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Caceres
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Zip/Postcode
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10003
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Country
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Spain
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Sponsor
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University of Extremadura (Spain)
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Address
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Avenida de Elvas, s/n
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City/town
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Badajoz
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Zip/Postcode
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06071
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Country
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Spain
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Sponsor website:
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http://www.unex.es
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Date applied
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29/06/2010
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Last edited
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06/07/2010
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Date ISRCTN assigned
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06/07/2010
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