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

ISRCTN	ISRCTN08691774
DOI	https://doi.org/10.1186/ISRCTN08691774
Protocol serial number	HTA 93/17/22
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	30/05/1999

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	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

United Kingdom
England

Study participating centre

Queen Victoria Road

Newcastle upon Tyne
NE1 4LP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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