Does early imaging influence management and improve outcome in patients with low back pain?

ISRCTN	ISRCTN74936953
DOI	https://doi.org/10.1186/ISRCTN74936953
Secondary identifying numbers	HTA 93/17/43

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

Study website

Contact information

Prof Fiona Gilbert
Scientific

Academic Department of Radiology
University of Aberdeen
Foresterhill Annex
Foresterhill
Aberdeen
AB9 2ZD
United Kingdom

Phone	+44 01224 559718
Email	f.j.gilbert@abdn.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	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 study start date	01/09/1996
Completion date	31/08/2001

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

Scotland
United Kingdom

Study participating centre

Academic Department of Radiology

Aberdeen
AB9 2ZD
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2004		Yes	No