Does early imaging influence management and improve outcome in patients with low back pain?
| ISRCTN | ISRCTN74936953 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74936953 |
| Protocol serial number | HTA 93/17/43 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 27/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Fiona Gilbert
Scientific
Scientific
Academic Department of Radiology
University of Aberdeen
Foresterhill Annex
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom
| Phone | +44 01224 559718 |
|---|---|
| f.j.gilbert@abdn.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | For many patients with back pain the optimal role and timing of imaging (lumbar spine radiography, magnetic resonance imaging, computed tomography, myelography) is unclear. The objectives of proposed study are (a) to determine whether early as opposed to delayed selective imaging significantly impacts on clinical management and patient outcome, and (b) to assess the resource implications of the two policies within a formal economic analysis. The application is for a Scottish-based, four-centred trial involving 1200 patients. |
| Ethics approval(s) | Not provided at time of registration. |
| Health condition(s) or problem(s) studied | Musculoskeletal diseases: Spinal conditions |
| Intervention | 1. Early imaging 2. Delayed, selective imaging (that is, only when a clear clinical indication develops and only when judged absolutely necessary by the clinician) A minimisation algorithm will be used to balance the 'random' allocation in respect of key prognostic variables. |
| Intervention type | Other |
| Primary outcome measure(s) |
The principle measures of patient outcome will be the Oswestry Disability Index and the SF 36 health status measure. Secondary measures will assess diagnostic impact, therapeutic impact and other parameters of health. Follow-up assessments will be performed at 6 and 24 months after entry. Secondary stratified analyses will explore the effects of pre-referral lumbar spine radiographs, amongst other factors. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/08/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 782 |
| Key inclusion criteria | Back pain patients referred to a consultant orthopaedic surgeon or neurosurgeon where there is clinical uncertainty about whether or when to perform imaging |
| Key exclusion criteria | Patients going for immediate surgery or discharged to primary care would not be eligible. |
| Date of first enrolment | 01/09/1996 |
| Date of final enrolment | 31/08/2001 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
Academic Department of Radiology
Aberdeen
AB9 2ZD
United Kingdom
AB9 2ZD
United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2004 | Yes | No | |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
