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

Contact information

Type

Scientific

Primary contact

Mrs Sally Kerry

ORCID ID

Contact details

Dept of General Practice & Primary Care
St Georges Hospital Medical School
Hunter Wing
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
+44 020 8725 2785
sgjdgp2@sghms.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/17/11

Study information

Scientific title

Acronym

Study hypothesis

A study in general practice to compare short- and long-term outcomes for patients with low back pain who are referred or not referred for lumbar spine X-ray after first presentation.

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

Randomised controlled trial (RCT) in UK general practices, with an observational arm to enable comparisons to be made with patients not recruited to the trial. Random allocation to immediate referral for X-ray or not.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Roland and Morris disability, Hospital Anxiety and Depression, EuroQol, Short Form with 36 items (SF-36), consultations and referrals at 6 weeks and 1 year.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/10/1995

Overall trial end date

31/03/1999

Reason abandoned

Eligibility

Participant inclusion criteria

Patients who consulted their general practitioner (GP) with low back pain and who had not consulted in the previous 4 weeks.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

94 practices

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/10/1995

Recruitment end date

31/03/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Dept of General Practice & Primary Care
London
SW17 0RE
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

HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11044957

Publication citations

  1. HTA monograph

    Kerry S, Hilton S, Patel S, Dundas D, Rink E, Lord J, Routine referral for radiography of patients presenting with low back pain: is patients' outcome influenced by GPs' referral for plain radiography?, Health Technol Assess, 2000, 4, 20, i-iv, 1-119.

Additional files

Editorial Notes