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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2001 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/11701101
Publication citations
-
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.