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

Dr Denise Kendrick

ORCID ID

Contact details

Division of General Practice
University of Nottingham
Floor 13
Tower Building
University Park
Nottingham
NG7 2RD
United Kingdom
+44 0115 8466914
denise.kendrick@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 93/17/13

Study information

Scientific title

Acronym

Study hypothesis

To test the hypotheses that:
1. Lumbar spine radiography in primary care patients with low back pain is not associated with improved patient outcomes, including pain, disability, health status, sickness absence, reassurance, and patient satisfaction or belief in the value of radiography.
2. Lumbar spine radiography in primary care patients with low back pain is not associated with changes in patient management, including medication use, and the use of primary and secondary care services, physical therapies and complementary therapies.
3. Participants choosing their treatment group (i.e. radiography or no radiography) do not have better outcomes than those randomised to a treatment group.
4. Lumbar spine radiography is not cost-effective compared with usual care without lumbar spine radiography.

Please note that, as of 16 January 2008, the end date of this trial has been updated from 31 December 1999 to 31 March 2000.

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

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal diseases: Spinal conditions

Intervention

Lumbar spine radiography and usual care versus usual care without radiography.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Roland adaptation of the Sickness Impact Profile, visual analogue pain scale, health status scale, EuroQol, use of primary and secondary care services, and physical and complementary therapies, sickness absence, medication use, patient satisfaction, reassurance and belief in value of radiography at 3 and 9 months post-randomisation.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/07/1995

Overall trial end date

31/03/2000

Reason abandoned

Eligibility

Participant inclusion criteria

Seventy-three general practices in Nottingham, North Nottinghamshire, Southern Derbyshire, North Lincolnshire and North Leicestershire. Fifty-two practices recruited participants to the trial.
Randomised arm: 421 participants with low back pain, with median duration of 10 weeks.
Patient preference arm: 55 participants with low back pain, with median duration of 11 weeks

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

476

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/07/1995

Recruitment end date

31/03/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of General Practice
Nottingham
NG7 2RD
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

2001 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11701101

Publication citations

  1. HTA monograph

    Kendrick D, Fielding K, Bentley E, Miller P, Kerslake R, Pringle M, The role of radiography in primary care patients with low back pain of at least 6 weeks duration: a randomised (unblinded) controlled trial., Health Technol Assess, 2001, 5, 30, 1-69.

Additional files

Editorial Notes