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"

ISRCTN	ISRCTN40949689
DOI	https://doi.org/10.1186/ISRCTN40949689
Protocol serial number	N/A
Sponsor	University of Extremadura (Spain)
Funder	University of Extremadura (Spain)

Submission date: 29/06/2010
Registration date: 06/07/2010
Last edited: 06/07/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Narcis Gusi
Scientific

Avda Universidad s/n
Caceres
10003
Spain

Study information

Primary study design	Interventional
Study design	Blinded randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	CTE project
Study objectives	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(s)	Biomedical Ethical Committee of the University of Extremadura approved on the 16th June 2010 (ref: 32/2010)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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)
Key secondary outcome measure(s)	1. Grade of satisfaction with programme 2. International Physical Activity Questionnaire (IPAQ) 3. Stage of change
Completion date	17/02/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	All
Target sample size at registration	100
Key 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
Key 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
Date of first enrolment	16/06/2010
Date of final enrolment	17/02/2011

Locations

Countries of recruitment

Spain

Study participating centre

Avda Universidad s/n

Caceres
10003
Spain

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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes