Condition category
Musculoskeletal Diseases
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
24/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Publication citations

Additional files

Editorial Notes

24/05/2016: No publications found, study status unverified