Table 3.
Trial registration data
Data category | Information |
Primary registry and trial identifying number | Australia New Zealand Clinical Trials Registry ACTRN12617001292369 |
Date of registration in primary registry | 07/09/2017 |
Secondary identifying numbers | Universal Trial Number U1111-1196-6323 |
Sources of monetary or material support | Sponsors (below) |
Primary sponsor | National Health and Medical Research Council - Research Committee Secretariat NHMRC GPO Box 1421 Canberra ACT 2601 |
Secondary sponsor | Medibank Health Research Fund - 720 Bourke Street, Docklands, VIC 3008 |
Contact for public queries | PH (p.hodges@uq.edu.au) |
Contact for scientific queries | PH (p.hodges@uq.edu.au) |
Public title | Efficacy of a multi-faceted web-based resource on spinal health literacy in patients with low back pain - a randomised controlled trial |
Scientific title | Efficacy of a multi-faceted web-based resource on spinal health literacy in patients with low back pain - a randomised controlled trial |
Countries of recruitment | Australia |
Health condition or problem studied | Low back pain |
Intervention | Multi-faceted web-based resource ‘MyBackPain’ |
Key inclusion and exclusion criteria | Inclusion criteria: >18 years of age, current low back pain, reside in Australia, adequate English to complete surveys, internet access for the duration of the trial |
Exclusion criteria: previous or existing spinal pathology (eg, fracture, cancer, infection, nerve root compromise) | |
Study type | Randomised controlled trial, participant and assessor blinding, central computerised randomisation |
Date of first enrolment | 06/12/2017 |
Target sample size | 440 (at least 25% acute participants that is, pain <6 weeks with a minimum of 1 month without symptoms) |
Recruitment status | Recruiting |
Primary outcome(s) | Health Literacy Questionnaire |
Key secondary outcomes | Quality of treatment preference (observed) Patient decision-making—measured by evaluation of observed treatment choices. Treatments used by the participant during the follow-up period will be scored against the recommendations provided in the MyBackPain website, and based on a 5-point rating: ‘strong evidence’, ‘some evidence’, ‘unclear evidence/untested’, ‘evidence of no effect’ and ‘harmful’. The average score will be used. |