A randomised controlled trial to assess the effectiveness, cost-effectiveness and cost benefit of routine referral for lumbar spine radiography in patients with low back pain

ISRCTN ISRCTN61629868
DOI https://doi.org/10.1186/ISRCTN61629868
Secondary identifying numbers HTA 93/17/13
Submission date
25/04/2003
Registration date
25/04/2003
Last edited
06/02/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Denise Kendrick
Scientific

Division of General Practice
University of Nottingham
Floor 13
Tower Building
University Park
Nottingham
NG7 2RD
United Kingdom

ORCiD logoORCID ID 0000-0003-3603-6542
Phone +44 0115 8466914
Email denise.kendrick@nottingham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeNot Specified
Scientific titleA randomised controlled trial to assess the effectiveness, cost-effectiveness and cost benefit of routine referral for lumbar spine radiography in patients with low back pain
Study objectivesTo 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(s)Current ethics approval as of 06/02/2019:
Queens Medical Centre, University Hospital, NHS Trust Ethics Committee, 03/04/1995.
Nottingham City Hospital Ethics Committee, 31/03/1995, ref. EC95/69.
Southern Derbyshire Ethics Committee, 19/09/1995, ref. 95/08/71.
North Lincolnshire Research Ethics Committee, 23/11/1995, ref. BBS/EAH/106.
North Nottinghamshire Health Authority, 03/04/1995, ref. NNHA/171.
Leicestershire Health Authority, 07/02/1997, ref. 4521.

Previous ethics approval:
Queens Medical Centre, Nottingham
Southern Derbyshire's ethics committee
North Lincolnshire's research ethics committee
North Nottinghamshire health authority
Leicestershire health authority
Health condition(s) or problem(s) studiedMusculoskeletal diseases: Spinal conditions
InterventionLumbar spine radiography and usual care versus usual care without radiography.
Intervention typeOther
Primary outcome measureRoland 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 measuresNot provided at time of registration.
Overall study start date01/07/1995
Completion date31/03/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants476
Key inclusion criteriaSeventy-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
Key exclusion criteriaNot provided at time of registration.
Date of first enrolment01/07/1995
Date of final enrolment31/03/2000

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of General Practice
Nottingham
NG7 2RD
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 logo "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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2001 Yes No
Results article results 17/02/2001 Yes No
Results article results 15/10/2002 Yes No

Editorial Notes

06/02/2019: The ethics approval was updated.
31/01/2019: The following changes were made:
1. The ORCID was added.
2. The ethics was added.
3. Publication references added.