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 |
| Protocol serial number | HTA 93/17/13 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- 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
Scientific
Division of General Practice
University of Nottingham
Floor 13
Tower Building
University Park
Nottingham
NG7 2RD
United Kingdom
 ORCID ID |
0000-0003-3603-6542 |
|---|---|
| Phone | +44 0115 8466914 |
| denise.kendrick@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study objectives | 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(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) studied | Musculoskeletal diseases: Spinal conditions |
| Intervention | Lumbar spine radiography and usual care versus usual care without radiography. |
| Intervention type | Other |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration. |
| Completion date | 31/03/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | All |
| Target sample size at registration | 476 |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration. |
| Date of first enrolment | 01/07/1995 |
| Date of final enrolment | 31/03/2000 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Division of General Practice
Nottingham
NG7 2RD
United Kingdom
NG7 2RD
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
