Condition category
Musculoskeletal Diseases
Date applied
29/06/2010
Date assigned
06/07/2010
Last edited
06/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Narcis Gusi

ORCID ID

Contact details

Avda Universidad s/n
Caceres
10003
Spain

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

http://www.unex.es

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

Publication citations

Additional files

Editorial Notes