Lumbar spine radiology in primary health care: clinical outcomes and cost-effectiveness

ISRCTN	ISRCTN08691774
DOI	https://doi.org/10.1186/ISRCTN08691774
Secondary identifying numbers	HTA 93/17/22

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 12/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr JP Owen
Scientific

Queen Victoria Road
Royal Victoria Infirmary
Newcastle upon Tyne
NE1 4LP
United Kingdom

Phone	+44 (0)191 282 4256
Email	j.y.stoddart@ncl.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	Lumbar spine radiology in primary health care: clinical outcomes and cost-effectiveness
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/10/1996
Completion date	30/05/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	1300
Key inclusion criteria	Not provided at time of registration.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/10/1996
Date of final enrolment	30/05/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queen Victoria Road

Newcastle upon Tyne
NE1 4LP
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

Editorial Notes

12/12/2019: No publications found. All search options exhausted.
24/05/2016: No publications found, study status unverified