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      Effectiveness of Surgery for Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis

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          Abstract

          Background

          The management of spinal stenosis by surgery has increased rapidly in the past two decades, however, there is still controversy regarding the efficacy of surgery for this condition. Our aim was to investigate the efficacy and comparative effectiveness of surgery in the management of patients with lumbar spinal stenosis.

          Methods

          Electronic searches were performed on MEDLINE, EMBASE, AMED, CINAHL, Web of Science, LILACS and Cochrane Library from inception to November 2014. Hand searches were conducted on included articles and relevant reviews. We included randomised controlled trials evaluating surgery compared to no treatment, placebo/sham, or to another surgical technique in patients with lumbar spinal stenosis. Primary outcome measures were pain, disability, recovery and quality of life. The PEDro scale was used for risk of bias assessment. Data were pooled with a random-effects model, and the GRADE approach was used to summarise conclusions.

          Results

          Nineteen published reports (17 trials) were included. No trials were identified comparing surgery to no treatment or placebo/sham. Pooling revealed that decompression plus fusion is not superior to decompression alone for pain (mean difference –3.7, 95% confidence interval –15.6 to 8.1), disability (mean difference 9.8, 95% confidence interval –9.4 to 28.9), or walking ability (risk ratio 0.9, 95% confidence interval 0.4 to 1.9). Interspinous process spacer devices are slightly more effective than decompression plus fusion for disability (mean difference 5.7, 95% confidence interval 1.3 to 10.0), but they resulted in significantly higher reoperation rates when compared to decompression alone (28% v 7%, P < 0.001). There are no differences in the effectiveness between other surgical techniques for our main outcomes.

          Conclusions

          The relative efficacy of various surgical options for treatment of spinal stenosis remains uncertain. Decompression plus fusion is not more effective than decompression alone. Interspinous process spacer devices result in higher reoperation rates than bony decompression.

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          Most cited references48

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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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            The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study.

            Does the PEDro scale measure only one construct ie, the methodological quality of clinical trials? What is the hierarchy of items of the PEDro scale from least to most adhered to? Is there any effect of year of publication of trials on item adherence? Are PEDro scale ordinal scores equivalent to interval data? Rasch analysis of two independent samples of 100 clinical trials from the PEDro database scored using the PEDro scale. Both samples of PEDro data showed fit to the Rasch model with no item misfit. The PEDro scale item hierarchy was the same in both samples, ranging from the most adhered to item random allocation, to the least adhered to item therapist blinding. There was no differential item functioning by year of publication. Original PEDro ordinal scores were highly correlated with transformed PEDro interval scores (r = 0.99). The PEDro scale is a valid measure of the methodological quality of clinical trials. It is valid to sum PEDro scale item scores to obtain a total score that can be treated as interval level measurement and subjected to parametric statistical analysis.
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              Use of placebo controls in the evaluation of surgery: systematic review

              Objective To investigate whether placebo controls should be used in the evaluation of surgical interventions. Design Systematic review. Data sources We searched Medline, Embase, and the Cochrane Controlled Trials Register from their inception to November 2013. Study selection Randomised clinical trials comparing any surgical intervention with placebo. Surgery was defined as any procedure that both changes the anatomy and requires a skin incision or use of endoscopic techniques. Data extraction Three reviewers (KW, BJFD, IR) independently identified the relevant trials and extracted data on study details, outcomes, and harms from included studies. Results In 39 out of 53 (74%) trials there was improvement in the placebo arm and in 27 (51%) trials the effect of placebo did not differ from that of surgery. In 26 (49%) trials, surgery was superior to placebo but the magnitude of the effect of the surgical intervention over that of the placebo was generally small. Serious adverse events were reported in the placebo arm in 18 trials (34%) and in the surgical arm in 22 trials (41.5%); in four trials authors did not specify in which arm the events occurred. However, in many studies adverse events were unrelated to the intervention or associated with the severity of the condition. The existing placebo controlled trials investigated only less invasive procedures that did not involve laparotomy, thoracotomy, craniotomy, or extensive tissue dissection. Conclusions Placebo controlled trial is a powerful, feasible way of showing the efficacy of surgical procedures. The risks of adverse effects associated with the placebo are small. In half of the studies, the results provide evidence against continued use of the investigated surgical procedures. Without well designed placebo controlled trials of surgery, ineffective treatment may continue unchallenged.
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                Author and article information

                Contributors
                Role: Academic Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                30 March 2015
                2015
                : 10
                : 3
                : e0122800
                Affiliations
                [1 ]The George Institute for Global Health, Sydney Medical School, University of Sydney, Sydney, NSW, Australia
                [2 ]Faculty of Health Sciences, University of Sydney, Sydney, NSW, Australia
                [3 ]South Western Sydney Clinical School, Ingham Institute for Applied Medical Research, University of New South Wales, Sydney, NSW, Australia
                [4 ]Department of General Practice, Erasmus Medical Centre, Rotterdam, The Netherlands
                [5 ]Department of Health Sciences, VU University, Amsterdam, The Netherlands
                [6 ]Institute of Bone and Joint Research, Sydney Medical School, University of Sydney, Sydney, NSW, Australia
                Toronto Western Hospital, CANADA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Conceived and designed the experiments: GCM MLF CGM PHF IAH. Performed the experiments: GCM MLF MBP MR. Analyzed the data: GCM MLF CGM IAH. Contributed reagents/materials/analysis tools: MvT BWK MBP MR. Wrote the paper: GCM MLF CGM PHF IAH. Critical revision of the manuscript for important intellectual content: MvT BWK.

                Article
                PONE-D-14-50481
                10.1371/journal.pone.0122800
                4378944
                25822730
                4bf1d725-a0e4-4e27-b50a-9a52803ce663
                Copyright @ 2015

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited

                History
                : 10 November 2014
                : 13 February 2015
                Page count
                Figures: 4, Tables: 2, Pages: 18
                Funding
                The authors have no support or funding to report.
                Categories
                Research Article
                Custom metadata
                All relevant data are within the paper and its Supporting Information files.

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