Jeremy Fairbank
Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial
Fairbank, Jeremy; Frost, Helen; Wilson-MacDonald, James; Yu, Ly-Mee; Barker, Karen; Collins, Rory
Authors
Helen Frost
James Wilson-MacDonald
Ly-Mee Yu
Karen Barker
Rory Collins
Abstract
Objectives
To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain.
Design
Multicentre randomised controlled trial.
Setting
15 secondary care orthopaedic and rehabilitation centres across the United Kingdom.
Participants 349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion.
Intervention
Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy.
Main outcome measure
The primary outcomes were the Oswestry disability index and the shuttle walking test measured at baseline and two years after randomisation. The SF-36 instrument was used as a secondary outcome measure.
Results
176 participants were assigned to surgery and 173 to rehabilitation. 284 (81%) provided follow-up data at 24 months. The mean Oswestry disability index changed favourably from 46.5 (SD 14.6) to 34.0 (SD 21.1) in the surgery group and from 44.8 (SD14.8) to 36.1 (SD 20.6) in the rehabilitation group. The estimated mean difference between the groups was –4.1 (95% confidence interval –8.1 to –0.1, P = 0.045) in favour of surgery. No significant differences between the treatment groups were observed in the shuttle walking test or any of the other outcome measures.
Conclusions
Both groups reported reductions in disability during two years of follow-up, possibly unrelated to the interventions. The statistical difference between treatment groups in one of the two primary outcome measures was marginal and only just reached the predefined minimal clinical difference, and the potential risk and additional cost of surgery also need to be considered. No clear evidence emerged that primary spinal fusion surgery was any more beneficial than intensive rehabilitation.
Citation
Fairbank, J., Frost, H., Wilson-MacDonald, J., Yu, L., Barker, K., & Collins, R. (2005). Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial. BMJ, 330(7502), 1233. https://doi.org/10.1136/bmj.38441.620417.8f
Journal Article Type | Article |
---|---|
Acceptance Date | Mar 24, 2005 |
Online Publication Date | May 26, 2005 |
Publication Date | May 28, 2005 |
Deposit Date | Oct 19, 2017 |
Publicly Available Date | Oct 19, 2017 |
Journal | BMJ |
Print ISSN | 0959-8138 |
Electronic ISSN | 1756-1833 |
Publisher | BMJ Publishing Group |
Peer Reviewed | Peer Reviewed |
Volume | 330 |
Issue | 7502 |
Pages | 1233 |
DOI | https://doi.org/10.1136/bmj.38441.620417.8f |
Public URL | http://researchrepository.napier.ac.uk/Output/999289 |
Contract Date | Oct 19, 2017 |
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Randomised controlled trial to compare surgical stabilisation of the lumbar spine with an intensive rehabilitation programme for patients with chronic low back pain: the MRC spine stabilisation trial
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http://creativecommons.org/licenses/by-nc/4.0/
Copyright Statement
Publisher is open-access. Open access publishing allows free access to and distribution of published articles where the author retains copyright of their work by employing a Creative Commons attribution licence. Proper attribution of authorship and correct citation details should be given. Published in BMJ 2005;330:1233
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