Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.abdn.ac.uk/hsru/hta/sbt.shtml

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

Additional files

Editorial Notes