Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
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
Acronym
CTE project
Study hypothesis
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
Ethics approval
Biomedical Ethical Committee of the University of Extremadura approved on the 16th June 2010 (ref: 32/2010)
Study design
Blinded randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-specific low back pain
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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)
Secondary outcome measures
1. Grade of satisfaction with programme
2. International Physical Activity Questionnaire (IPAQ)
3. Stage of change
Overall trial start date
16/06/2010
Overall trial end date
17/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100
Participant exclusion criteria
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
Recruitment start date
16/06/2010
Recruitment end date
17/02/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Avda Universidad s/n
Caceres
10003
Spain
Sponsor information
Organisation
University of Extremadura (Spain)
Sponsor details
Avenida de Elvas
s/n
Badajoz
06071
Spain
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Extremadura (Spain)
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