Contact information
Type
Scientific
Primary contact
Dr JP Owen
ORCID ID
Contact details
Queen Victoria Road
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom
+44 (0)191 282 4256
j.y.stoddart@ncl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 93/17/22
Study information
Scientific title
Lumbar spine radiology in primary health care: clinical outcomes and cost-effectiveness
Acronym
Study hypothesis
We propose to conduct a randomised controlled trial (RCT) of lumbar spine radiology in primary health care focused on general practices and their local hospital radiology departments in the former Northern and Yorkshire region of the NHS. 1,300 patients will be randomised as follows:
Group 1 - no hospital radiology referral (400)
Group 2 - simulated (placebo) X-ray procedure (300)
Group 3 - lumbar spine radiology (600)
The study will ensure that a comparison of 600 patients receiving lumbar spine radiology with 700 patients acting as controls has a 95% power to detect a 0.25 sd difference at the 1% level on the Aberdeen scale.
Please note that, as of 11/05/2009, the anticipated end date has been updated from 30/04/1999 to 30/05/1999.
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
Group 1 - no hospital radiology referral (400)
Group 2 - simulated (placebo) X-ray procedure (300)
Group 3 - lumbar spine radiology (600)
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. General health profile (SF36)
2. Condition specific questionnaire for low back pain (Aberdeen scale)
3. Quality of life instrument (Euroquol)
4. Treatments given
5. Referrals made
6. Numbers of consultations
7. Numbers, lengths and costs of certified absences from work
8. Radiological reports
Secondary outcome measures
Not provided at time of registration.
Overall trial start date
01/10/1996
Overall trial end date
30/05/1999
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
1300
Participant exclusion criteria
Not provided at time of registration.
Recruitment start date
01/10/1996
Recruitment end date
30/05/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Victoria Road
Newcastle upon Tyne
NE1 4LP
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