Fairbank J, Frost H, Wilson-MacDonald J, Yu LM, Barker K, Collins R. 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.330:1233

The University of Warwick, Coventry, England, United Kingdom
BMJ (online) (Impact Factor: 17.45). 06/2005; 330(7502):1233. DOI: 10.1136/bmj.38441.620417.8F
Source: PubMed


To assess the clinical effectiveness of surgical stabilisation (spinal fusion) compared with intensive rehabilitation for patients with chronic low back pain.
Multicentre randomised controlled trial.
15 secondary care orthopaedic and rehabilitation centres across the United Kingdom.
349 participants aged 18-55 with chronic low back pain of at least one year's duration who were considered candidates for spinal fusion.
Lumbar spine fusion or an intensive rehabilitation programme based on principles of cognitive behaviour therapy.
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.
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.
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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Available from: Karen Barker, Oct 05, 2015
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    • "The fear-avoidance model, as presented by Vlayen and Linton [35] is depicted in Figure 1. As described earlier, interventions that have used CBT approaches to target catastrophizing and fear-avoidance behaviours have shown an association with a reduction in pain behaviours, physical disability and depression in both surgical and non-surgical CLBP patients [13,20,21,36,37]. "
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    ABSTRACT: The ideal rehabilitation strategy following lumbar spinal fusion surgery has not yet been established. This paper is a study protocol, describing the rationale behind and the details of a cognitive-behavioural rehabilitation intervention for lumbar spinal fusion patients based on the best available evidence. Predictors of poor outcome following spine surgery have been identified to provide targets for the intervention, and the components of the intervention were structured in accordance with the cognitive-behavioural model. The study aims to compare the clinical and economical effectiveness of a cognitive-behavioural rehabilitation strategy to that of usual care for patients undergoing lumbar spinal fusion surgery. The study is a randomized clinical trial including 96 patients scheduled for lumbar spinal fusion surgery due to degenerative disease or spondylolisthesis. Patients were recruited in the period October 2011 to July 2013, and the follow-up period is one year from date of surgery. Patients are allocated on a 1:2 ratio (control : intervention) to either treatment as usual (control group), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (intervention group). It takes place in a hospital setting, and consists of six group-based sessions, managed by a multidisciplinary team of health professionals.The primary outcomes are disability (Oswestry Disability Index) and sick leave, while secondary outcomes include coping (Coping Strategies Questionnaire), fear-avoidance belief (Fear Avoidance Belief Questionnaire), pain (Low Back Pain Rating Scale, pain index), mobility during hospitalization (Cumulated Ambulation Score), generic health-related quality of life (EQ-5D) and resource use. Outcomes are measured using self report questionnaires, medical records and national registers. It is expected that the intervention can provide better functional outcome, less pain and earlier return to work after lumbar spinal fusion surgery. By combining knowledge and evidence from different knowledge areas, the project aims to provide new knowledge that can create greater consistency in patient treatment. We expect that the results can make a significant contribution to development of guidelines for good rehabilitation of patients undergoing lumbal spinal fusion.Trial registration: Current Controlled Trials ISRCTN42281022.
    BMC Musculoskeletal Disorders 03/2014; 15(1):62. DOI:10.1186/1471-2474-15-62 · 1.72 Impact Factor
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    • "It remains unclear, for example , whether there is a localized peripheral generator of back pain [13] (ie, the intervertebral disc), whether imaging studies such as magnetic resonance imaging (MRI) [14] or diagnostic tests such as discography [15] can distinguish painful from nonpainful discs, or whether such a pain source can be eliminated by nonsurgical treatment, excision, fusion, or artificial disc replacement. Lack of consensus regarding the efficacy of lumbar spinal fusion for discogenic back pain is particularly troubling because four European randomized trials have compared fusion with nonsurgical care [16] [17] [18] [19]. Fusion showed a small benefit for back disability compared with nonstandardized nonsurgical care but roughly similar benefit compared with intensive rehabilitation incorporating cognitive behavior therapy [20]. "
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    ABSTRACT: The clinical entity "discogenic back pain" remains controversial at fundamental levels, including its pathophysiology, diagnostic criteria, and optimal treatment. This is true despite availability of four randomized trials comparing the efficacy of surgical and nonsurgical treatments. One trial showed benefit for lumbar fusion compared with unstructured nonoperative care, and three others showed roughly similar results for lumbar surgery and structured rehabilitation. To compare outcomes of community-based surgical and nonsurgical treatments for patients with chronic back pain attributed to degeneration at one or two lumbar disc levels. Prospective observational cohort study. Patients presenting with axial back pain to academic and private practice orthopedic surgeons and neurosurgeons in a large metropolitan area. Roland-Morris back disability score (primary outcome), current rating of overall pain severity on a numerical scale, back and leg pain bothersomeness measures, the physical function scale of the short-form 36 version 2 questionnaire, use of medications for pain, work status, emergency department visits, hospitalizations, and further surgery. Patients receiving spine surgery within 6 months of enrollment were designated as the "surgical treatment" group and the remainder as "nonsurgical treatment." Outcomes were assessed at 3, 6, 9, and 12 months after enrollment. We enrolled 495 patients with discogenic back pain presenting for initial surgical consultation in offices of 16 surgeons. Eighty-six patients (17%) had surgery within 6 months of enrollment. Surgery consisted of instrumented fusion (79%), disc replacement (12%), laminectomy, or discectomy (9%). Surgical patients reported more severe pain and physical disability at baseline and were more likely to have had prior surgery. Adjusting for baseline differences among groups, surgery showed a limited benefit over nonsurgical treatment of 5.4 points on the modified (23-point) Roland disability questionnaire (primary outcome) 1 year after enrollment. Using a composite definition of success incorporating 30% improvement in the Roland score, 30% improvement in pain, no opioid pain medication use, and working (if relevant), the 1-year success rate was 33% for surgery and 15% for nonsurgical treatment. The rate of reoperation was 11% in the surgical group; the rate of surgery after treatment designation in the nonsurgical group was 6% at 12 months after enrollment. The surgical group showed greater improvement at 1 year compared with the nonsurgical group, although the composite success rate for both treatment groups was only fair. The results should be interpreted cautiously because outcomes are short term, and treatment was not randomly assigned. Only 5% of nonsurgical patients received cognitive behavior therapy. Nonsurgical treatment that patients received was variable and mostly not compliant with major guidelines.
    The spine journal: official journal of the North American Spine Society 07/2013; 13(11). DOI:10.1016/j.spinee.2013.05.047 · 2.43 Impact Factor
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    • "The number of lumbar fusion operations performed for CLBP and disc degeneration has increased rapidly in the past two decades, but the effectiveness of lumbar fusion surgery has been questioned after the publication of three randomised trials [7] [8] [9], two of these concluding that lumbar fusion is no more effective than cognitive behavioral intervention. *Address correspondence to this author at the Department of Orthopaedic Surgery, Oslo University Hospital, Rikshospitalet, 0027 Oslo, Norway; Tel: (+47) 90196984; E-mail: Patients fused for disc degeneration and CLBP may be more prone to further degeneration than the rest of the population. "
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    ABSTRACT: To compare lumbar disc degeneration at 9-year follow-up in patients with chronic low back pain who had instrumented lumbar fusion or no fusion. The main outcomes were disc height and sagittal alignment measured by Distortion Compensated Roentgen Analysis (DCRA). Secondary outcome included the Oswestry Disability Index and VAS back pain. Forty-eight patients with baseline and 9-year radiographs from L2- S1 were included. Twenty-three had lumbar fusion and 25 had no fusion. Disc height was reduced at all levels independent of fusion. No difference in disc height and sagittal alignment was observed between patients fused and not fused. There were weak correlations, ranging from 0.04 to 0.36, between clinical and radiological parameters. Lumbar disc degeneration increased at all measured levels independent of fusion and correlated poorly with clinical outcome.
    The Open Orthopaedics Journal 06/2013; 7:258-63. DOI:10.2174/1874325001307010258
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