Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Fiona Gilbert
ORCID ID
Contact details
Academic Department of Radiology
University of Aberdeen
Foresterhill Annex
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom
+44 01224 559718
f.j.gilbert@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/17/43
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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.
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/09/1996
Overall trial end date
31/08/2001
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
782
Participant exclusion criteria
Patients going for immediate surgery or discharged to primary care would not be eligible.
Recruitment start date
01/09/1996
Recruitment end date
31/08/2001
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Department of Radiology
Aberdeen
AB9 2ZD
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
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
2004 results in http://www.ncbi.nlm.nih.gov/pubmed/15031430
Publication citations
-
Results
Gilbert FJ, Grant AM, Gillan MG, Vale LD, Campbell MK, Scott NW, Knight DJ, Wardlaw D, , Low back pain: influence of early MR imaging or CT on treatment and outcome--multicenter randomized trial., Radiology, 2004, 231, 2, 343-351, doi: 10.1148/radiol.2312030886.