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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| Authors: | Jeremy Fairbank Helen Frost James Wilson-MacDonald Ly-Mee Yu Karen Barker Rory Collins for the Spine Stabilisation Trial Group |
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| Institution: | 1. Nuffield Orthopaedic Centre, Oxford OX3 7LD;2. University of Warwick, Division of Health in the Community, Coventry CV4 7AL;3. Centre for Statistics in Medicine, Oxford OX3 7LF;4. Clinical Trial Service Unit and Epidemiological Studies Unit, Radcliffe Infirmary, Oxford OX2 6HE |
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| 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. |
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