Systematic reviews including this primary study

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Systematic review

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Journal Cochrane Database of Systematic Reviews
Year 2016
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Background: Lumbar spinal stenosis (LSS) is a debilitating condition associated with degeneration of the spine with aging. Objectives: To evaluate the effectiveness of different types of surgery compared with different types of non-surgical interventions in adults with symptomatic LSS. Primary outcomes included quality of life, disability, function and pain. Also, to consider complication rates and side effects, and to evaluate short-, intermediate- and long-term outcomes (six months, six months to two years, five years or longer). Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, five other databases and two trials registries up to February 2015. We also screened reference lists and conference proceedings related to treatment of the spine. Selection criteria: Randomised controlled trials (RCTs) comparing surgical versus non-operative treatments in participants with lumbar spinal stenosis confirmed by clinical and imaging findings. Data collection and analysis: For data collection and analysis, we followed methods guidelines of the Cochrane Back and Neck Review Group (Furlan 2009) and those provided in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011). Main results: From the 12,966 citations screened, we assessed 26 full-text articles and included five RCTs (643 participants). Low-quality evidence from the meta-analysis performed on two trials using the Oswestry Disability Index (pain-related disability) to compare direct decompression with or without fusion versus multi-modal non-operative care showed no significant differences at six months (mean difference (MD) -3.66, 95% confidence interval (CI) -10.12 to 2.80) and at one year (MD -6.18, 95% CI -15.03 to 2.66). At 24 months, significant differences favoured decompression (MD -4.43, 95% CI -7.91 to -0.96). Low-quality evidence from one small study revealed no difference in pain outcomes between decompression and usual conservative care (bracing and exercise) at three months (risk ratio (RR) 1.38, 95% CI 0.22 to 8.59), four years (RR 7.50, 95% CI 1.00 to 56.48) and 10 years (RR 4.09, 95% CI 0.95 to 17.58). Low-quality evidence from one small study suggested no differences at six weeks in the Oswestry Disability Index for patients treated with minimally invasive mild decompression versus those treated with epidural steroid injections (MD 5.70, 95% CI 0.57 to 10.83; 38 participants). Zurich Claudication Questionnaire (ZCQ) results were better for epidural injection at six weeks (MD -0.60, 95% CI -0.92 to -0.28), and visual analogue scale (VAS) improvements were better in the mild decompression group (MD 2.40, 95% CI 1.92 to 2.88). At 12 weeks, many cross-overs prevented further analysis. Low-quality evidence from a single study including 191 participants favoured the interspinous spacer versus usual conservative treatment at six weeks, six months and one year for symptom severity and physical function. All remaining studies reported complications associated with surgery and conservative side effects of treatment: Two studies reported no major complications in the surgical group, and the other study reported complications in 10% and 24% of participants, including spinous process fracture, coronary ischaemia, respiratory distress, haematoma, stroke, risk of reoperation and death due to pulmonary oedema. Authors' conclusions: We have very little confidence to conclude whether surgical treatment or a conservative approach is better for lumbar spinal stenosis, and we can provide no new recommendations to guide clinical practice. However, it should be noted that the rate of side effects ranged from 10% to 24% in surgical cases, and no side effects were reported for any conservative treatment. No clear benefits were observed with surgery versus non-surgical treatment. These findings suggest that clinicians should be very careful in informing patients about possible treatment options, especially given that conservative treatment options have resulted in no reported side effects. High-quality research is needed to compare surgical versus conservative care for individuals with lumbar spinal stenosis. © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

Systematic review

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Authors Chou D , Lau D , Hermsmeyer J , Norvell D
Journal Evidence-based spine-care journal
Year 2011
STUDY DESIGN: Systematic review using a modified network analysis. OBJECTIVES: To compare the effectiveness and morbidity of interspinous-device placement versus surgical decompression for the treatment of lumbar spinal stenosis. SUMMARY: Traditionally, the most effective treatment for degenerative lumbar spinal stenosis is through surgical decompression. Recently, interspinous devices have been used in lieu of standard laminectomy. METHODS: A review of the English-language literature was undertaken for articles published between 1970 and March 2010. Electronic databases and reference lists of key articles were searched to identify studies comparing surgical decompression with interspinous-device placement for the treatment of lumbar spinal stenosis. First, studies making the direct comparison (cohort or randomized trials) were searched. Second, randomized controlled trials (RCTs) comparing each treatment to conservative management were searched to allow for an indirect comparison through a modified network analysis approach. Comparison studies involving simultaneous decompression with placement of an interspinous device were not included. Studies that did not have a comparison group were not included since a treatment effect could not be calculated. Two independent reviewers assessed the strength of evidence using the GRADE criteria assessing quality, quantity, and consistency of results. The strengths of evidence for indirect comparisons were downgraded. Disagreements were resolved by consensus. RESULTS: We identified five studies meeting our inclusion criteria. No RCTs or cohort studies were identified that made the direct comparison of interspinous-device placement with surgical decompression. For the indirect comparison, three RCTs compared surgical decompression to conservative management and two RCTs compared interspinous-device placement to conservative management. There was low evidence supporting greater treatment effects for interspinous-device placement compared to decompression for disability and pain outcomes at 12 months. There was low evidence demonstrating little to no difference in treatment effects between the groups for walking distance and complication rates. CONCLUSION: The indirect treatment effect for disability and pain favors the interspinous device compared to decompression. The low evidence suggests that any further research is very likely to have an important impact on the confidence in the estimate of effect and is likely to change the estimate. No significant treatment effect differences were observed for postoperative walking distance improvement or complication rates; however, findings should be considered with caution because of indirect comparisons and short follow-up periods.

Systematic review

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Journal Spine
Year 2011
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STUDY DESIGN: Systematic review. OBJECTIVE: To compare the effectiveness of surgery versus conservative treatment on pain, disability, and loss of quality of life caused by symptomatic lumbar spinal stenosis (LSS). SUMMARY OF BACKGROUND DATA: LSS is the most common reason for spine surgery in persons older than 65 years in the United States. METHODS: Randomized controlled trials (RCTs) comparing any form of conservative and surgical treatment were searched in CENTRAL, MEDLINE, EMBASE, and TripDatabase databases until July 2009, with no language restrictions. Additional data were requested from the authors of the original studies. The methodological quality of each study was assessed independently by two reviewers, following the criteria recommended by the Cochrane Back Review Group. Only data from randomized cohorts were extracted. RESULTS: A total of 739 citations were reviewed. Eleven publications corresponding to five RCTs were included. All five scored as high quality despite concerns deriving from heterogeneity of treatment, lack of blinding, and potential differences in the size of the placebo effect across groups. They included a total of 918 patients in whom conservative treatments had failed for 3 to 6 months, and included orthosis, rehabilitation, physical therapy, exercise, heat and cold, transcutaneous electrical nerve stimulation, ultrasounds, analgesics, nonsteroidal anti-inflammatory drugs, and epidural steroids. Surgical treatments included the implantation of a specific type of interspinous device and decompressive surgery (with and without fusion, instrumented or not). In all the studies, surgery showed better results for pain, disability, and quality of life, although not for walking ability. Results of surgery were similar among patients with and without spondylolisthesis, and slightly better among those with neurogenic claudication than among those without it. The advantage of surgery was noticeable at 3 to 6 months and remained for up to 2 to 4 years, although at the end of that period differences tended to be smaller. CONCLUSION: In patients with symptomatic LSS, the implantation of a specific type of device or decompressive surgery, with or without fusion, is more effective than continued conservative treatment when the latter has failed for 3 to 6 months.