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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Avda Universidad s/n
Caceres
10003
Spain
Study information
| Study design | Blinded randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 16/06/2010 |
| Completion date | 17/02/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 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
10003
Spain
Sponsor information
University of Extremadura (Spain)
University/education
University/education
Avenida de Elvas, s/n
Badajoz
06071
Spain
| Website | http://www.unex.es |
|---|---|
"ROR" |
https://ror.org/0174shg90 |
Funders
Funder type
University/education
University of Extremadura (Spain)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
