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      Surgery with disc prosthesis versus rehabilitation in patients with low back pain and degenerative disc: two year follow-up of randomised study

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          Abstract

          Objective To compare the efficacy of surgery with disc prosthesis versus non-surgical treatment for patients with chronic low back pain.

          Design A prospective randomised multicentre study.

          Setting Five university hospitals in Norway.

          Participants 173 patients with a history of low back pain for at least one year, Oswestry disability index of at least 30 points, and degenerative changes in one or two lower lumbar spine levels (86 patients randomised to surgery). Patients were treated from April 2004 to September 2007.

          Interventions Surgery with disc prosthesis or outpatient multidisciplinary rehabilitation for 12-15 days.

          Main outcome measures The primary outcome measure was the score on the Oswestry disability index after two years. Secondary outcome measures were low back pain, satisfaction with life (SF-36 and EuroQol EQ-5D), Hopkins symptom check list (HSCL-25), fear avoidance beliefs (FABQ), self efficacy beliefs for pain, work status, and patients’ satisfaction and drug use. A blinded independent observer evaluated scores on the back performance scale and Prolo scale at two year follow-up.

          Results The study was powered to detect a difference of 10 points on the Oswestry disability index between the groups at two years. At two years there was a mean difference of −8.4 points (95% confidence interval −13.2 to −3.6) in favour of surgery. In the analysis of prespecified secondary outcomes, there were significant differences in favour of surgery for low back pain (mean difference −12.2, −21.3 to −3.1), patients’ satisfaction (63% (n=46) v 39% (n=26)), SF-36 physical component score (mean difference 5.8, 2.5 to 9.1), self efficacy for pain (mean difference 1.0, 0.2 to 1.9), and the Prolo scale (mean difference 0.9, 0.1 to 1.6). There were no significant differences in return to work, SF-36 mental component score, EQ-5D, fear avoidance beliefs, Hopkins symptom check list, drug use, and the back performance scale. One serious complication of leg amputation occurred during surgical revision of a polyethylene dislodgement. The drop-out rate was 20% (34) and the crossover rate was 6% (5).

          Conclusions Surgical intervention with disc prosthesis for chronic low back pain resulted in a significantly greater improvement in the Oswestry score compared with rehabilitation, but this improvement did not clearly exceed the prespecified minimally important clinical difference between groups of 10 points, and the data are consistent with a wide range of differences between the groups, including values well below 10 points. The potential risks of surgery and the substantial amount of improvement experienced by a sizeable proportion of the rehabilitation group also have to be incorporated into overall decision making.

          Trial registration NCT 00394732.

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          Most cited references35

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          SF-36 health survey update.

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            Low back pain in relation to lumbar disc degeneration.

            Cross-sectional magnetic resonance imaging (MRI) study. To study the relation of low back pain (LBP) to disc degeneration in the lumbar spine. Controversy still prevails about the relationship between disc degeneration and LBP. Classification of disc degeneration and symptoms varies, hampering comparison of study results. Subjects comprised 164 men aged 40-45 years-53 machine drivers, 51 construction carpenters, and 60 office workers. The data of different types of LBP, individual characteristics, and lifestyle factors were obtained from a questionnaire and a structured interview. Degeneration of discs L2/L3-L5/S1 (dark nucleus pulposus and posterior and anterior bulge) was assessed with MRI. An increased risk of LBP (including all types) was found in relation to all signs of disc degeneration. An increased risk of sciatic pain was found in relation to posterior bulges, but local LBP was not related to disc degeneration. The risks of LBP and sciatic pain were strongly affected by occupation. Low back pain is associated with signs of disc degeneration and sciatic pain with posterior disc bulges. Low back pain is strongly associated with occupation.
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              A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures.

              Vertebroplasty has become a common treatment for painful osteoporotic vertebral fractures, but there is limited evidence to support its use. We performed a multicenter, randomized, double-blind, placebo-controlled trial in which participants with one or two painful osteoporotic vertebral fractures that were of less than 12 months' duration and unhealed, as confirmed by magnetic resonance imaging, were randomly assigned to undergo vertebroplasty or a sham procedure. Participants were stratified according to treatment center, sex, and duration of symptoms ( or = 6 weeks). Outcomes were assessed at 1 week and at 1, 3, and 6 months. The primary outcome was overall pain (on a scale of 0 to 10, with 10 being the maximum imaginable pain) at 3 months. A total of 78 participants were enrolled, and 71 (35 of 38 in the vertebroplasty group and 36 of 40 in the placebo group) completed the 6-month follow-up (91%). Vertebroplasty did not result in a significant advantage in any measured outcome at any time point. There were significant reductions in overall pain in both study groups at each follow-up assessment. At 3 months, the mean (+/-SD) reductions in the score for pain in the vertebroplasty and control groups were 2.6+/-2.9 and 1.9+/-3.3, respectively (adjusted between-group difference, 0.6; 95% confidence interval, -0.7 to 1.8). Similar improvements were seen in both groups with respect to pain at night and at rest, physical functioning, quality of life, and perceived improvement. Seven incident vertebral fractures (three in the vertebroplasty group and four in the placebo group) occurred during the 6-month follow-up period. We found no beneficial effect of vertebroplasty as compared with a sham procedure in patients with painful osteoporotic vertebral fractures, at 1 week or at 1, 3, or 6 months after treatment. (Australian New Zealand Clinical Trials Registry number, ACTRN012605000079640.) 2009 Massachusetts Medical Society
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                Author and article information

                Contributors
                Role: orthopaedic surgeon
                Role: orthopaedic surgeon
                Role: physiotherapist
                Role: neurosurgeon
                Role: consultant
                Role: orthopaedic surgeon
                Role: consultant
                Role: professor
                Role: orthopaedic surgeon
                Journal
                BMJ
                bmj
                BMJ : British Medical Journal
                BMJ Publishing Group Ltd.
                0959-8138
                1468-5833
                2011
                2011
                19 May 2011
                : 342
                : d2786
                Affiliations
                [1 ]Department of Orthopaedics, Oslo University Hospital and University of Oslo, Kirkevn 166, 0407 Oslo, Norway
                [2 ]National Centre for Diseases of the Spine, University Hospital of Trondheim, 7030 Trondheim
                [3 ]Orthopaedic Department, University Hospital of Trondheim, 7030 Trondheim
                [4 ]Norwegian Research Centre for Active Rehabilitation (NAR), Department of Orthopaedics, Oslo University Hospital, Kirkevn 166, 0407 Oslo
                [5 ]Hjelp24, Nimi, Oslo Sognsveien 75 D, 0855 Oslo
                [6 ]Faculty of Medicine, Norwegian University of Science and Technology, Trondheim, Høgskoleringen 1, 7491 Trondheim (MR), FORMI, Oslo University Hospital, Kirkevn 166, 0407 Oslo
                [7 ]Multidiscipline Spinal Unit, Department of Physical Medicine and Rehabilitation, University Hospital of Trondheim, 7030 Trondheim
                [8 ]Section for Biostatistics and Epidemiology, Oslo University Hospital, Kirkevn 166, 0407 Oslo
                Author notes
                Correspondence to: C Hellum christian.hellum@ 123456medisin.uio.no
                Article
                helc798710
                10.1136/bmj.d2786
                3100911
                21596740
                e5d2998e-5150-4f84-a227-4f225f77929f
                © Hellum et al 2011

                This is an open-access article distributed under the terms of the Creative Commons Attribution Non-commercial License, which permits use, distribution, and reproduction in any medium, provided the original work is properly cited, the use is non commercial and is otherwise in compliance with the license. See: http://creativecommons.org/licenses/by-nc/2.0/ and http://creativecommons.org/licenses/by-nc/2.0/legalcode.

                History
                : 25 March 2011
                Categories
                Research
                Patients
                Pain (Neurology)
                Orthopaedic and Trauma Surgery

                Medicine
                Medicine

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