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 trialBMJ 2005; 330 doi: http://dx.doi.org/10.1136/bmj.38441.620417.8F (Published 26 May 2005) Cite this as: BMJ 2005;330:1233
- Jeremy Fairbank, consultant orthopaedic surgeon ()1,
- Helen Frost, research fellow2,
- James Wilson-MacDonald, consultant orthopaedic surgeon1,
- Ly-Mee Yu, statistician3,
- Karen Barker, director of physiotherapy research1,
- Rory Collins, professor4
- for the Spine Stabilisation Trial Group
- 1Nuffield Orthopaedic Centre, Oxford OX3 7LD
- 2University of Warwick, Division of Health in the Community, Coventry CV4 7AL
- 3Centre for Statistics in Medicine, Oxford OX3 7LF
- 4Clinical Trial Service Unit and Epidemiological Studies Unit, Radcliffe Infirmary, Oxford OX2 6HE
- Correspondence to: J Fairbank
- Accepted 24 March 2005
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.
Additional contributors and members of the MRC steering committee are on www.bmj.com
Contributors JF was responsible for the overall study design, the organisation of the study, recruiting and operating on patients in the study, data analysis, and wrote the first draft of this report. HF was responsible for overall study design, the organisation of the study, the design and implementation of the rehabilitation programme, data analysis, and writing the first draft of the report. JWM was responsible for overall study design, the organisation of the study, recruiting and operating on patients in the study, data analysis, and editing the report. RC was responsible for overall study design, statistical advice and data analysis, and presented analyses to the data monitoring committee. LMY was responsible for statistical analysis. JF and HF are guarantors. KB was responsible for recruiting patients and data analysis. Of the contributors who are not listed as authors, Douglas Altman was responsible for statistical analysis and sat on the data monitoring committee. Alastair Gray was responsible for study design, the organisation of the study and economic analysis. Nicolas Maniadakis was responsible for economic data collection and analysis. Kate Johnston, Helen Campbell, and Oliver Rivero were responsible for economic analysis. Patricia Carver was responsible for data collection and analysis. L Morgan was responsible for data collection and database design. Kate Stevens, Victoria Erlanger, Rebecca Bale collected and entered data. Peter Smith developed and maintained the database.
Funding The Medical Research Council supported the trial financially and was represented on the steering committee. The NHS (326) or private patient insurance (23) funded the treatment of patients. MRC grant number G94431172.
Competing interests JF and JWM have received funding from Synthes for a spinal fellow.
Ethical approval The trial was approved by a multicentre research ethics committee (twice; references 98/5/14 for original and 03/05/034 for long term follow-up) and 15 local research ethics committees.
- Accepted 24 March 2005