Figures
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.
Citation: Machado GC, Ferreira PH, Harris IA, Pinheiro MB, Koes BW, van Tulder M, et al. (2015) Effectiveness of Surgery for Lumbar Spinal Stenosis: A Systematic Review and Meta-Analysis. PLoS ONE 10(3): e0122800. https://doi.org/10.1371/journal.pone.0122800
Academic Editor: Mohammed Shamji, Toronto Western Hospital, CANADA
Received: November 10, 2014; Accepted: February 13, 2015; Published: March 30, 2015
Copyright: © 2015 Machado et al. 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
Data Availability: All relevant data are within the paper and its Supporting Information files.
Funding: The authors have no support or funding to report.
Competing interests: The authors have declared that no competing interests exist.
Introduction
Lumbar spinal stenosis is a narrowing of the spinal canal by surrounding bone and soft tissues that compromises neural structures. Radiographic findings of spinal stenosis are highly prevalent [1], and 85% of patients typically present with significant long-term symptoms of intermittent neurogenic claudication (radicular pain during walking or standing that resolves with lumbar flexion) [2]. When refractory to conservative treatment, patients are commonly referred for surgery [3, 4]. As a result, the number of surgical procedures performed for lumbar spinal stenosis has increased steadily over the years (e.g., the rates of complex fusion surgery had a 15-fold increase between 2002 and 2007) [5], with costs reaching USD $1.65 billion per year [6]. However, there is still a substantial variation in the surgical technique chosen by surgeons [7, 8], although no clear superiority of one technique over the others has been yet identified [9–11].
The current evidence suggests that surgery for spinal stenosis is more effective than conservative treatment when the latter has failed for up to six months [12, 13]. For instance, in the Spine Patient Outcomes Research Trial (SPORT) patients treated surgically reported lower pain levels compared to patients assigned to nonsurgical care [14]. The gold standard surgical approach for lumbar spinal stenosis is bony decompression by laminectomy [15, 16]. However, due to the occurrence of complications associated with this technique [17], less invasive surgical techniques have been proposed, such as unilateral or bilateral laminotomies [18–20], and spinous process split–laminectomy [21]. Additionally, as spinal instability is a frequent finding following bony decompression [22, 23], surgical fusion has been recommended in addition to decompression of the spinal canal for the management of some patients with spinal stenosis [24]. However, this practice can be associated with higher reoperation rates, post-surgical complications, and costs when compared to decompression alone [25]. Although many surgical techniques are available for the management of lumbar spinal stenosis, there seems to be a paucity of evidence supporting this rapid evolution of surgical techniques, and clinicians are usually asked to rely on their own opinions and experiences [26].
Therefore, in this systematic review we aimed to determine the efficacy of surgery in the management of patients with lumbar spinal stenosis and the comparative effectiveness between commonly performed surgical techniques to treat this condition.
Material and Methods
Data sources and search
We conducted a systematic review and meta-analysis following the recommendations of the PRISMA statement [27]. The methods of this review have been previously registered with PROSPERO, number CRD42013005901. We performed a systematic electronic search on MEDLINE, EMBASE, AMED, CINAHL, Web of Science, LILACS and Cochrane Central Register of Controlled Trials from the date of inception until June 2014. The search strategy is in S1 Table. Hand searches of references were also conducted on relevant reviews and included studies.
Study selection
Two independent reviewers (GM and MP/MR) performed the selection of studies and consensus was used to resolve any disagreement. To be included, studies needed to be full published randomised controlled trials comparing the efficacy of surgery to no treatment, placebo/sham, or comparing the effectiveness of different types of surgical procedures. Trials were included if they explicitly reported that subjects were treated for lumbar spinal stenosis, despite its anatomical classification (central, foraminal or lateral), or diagnostic criteria. There were no restrictions regarding intensity or duration of symptoms, language or publication date. Studies of patients with trauma, tumour, and previous spine surgery were excluded. As degenerative spondylolisthesis is a common finding in patients with lumbar spinal stenosis, only trials including patients with spondylolisthesis greater than grade I were excluded. Review articles, guidelines, observational studies, trials comparing different types of fusion techniques, and surgery for cervical spine stenosis were also excluded.
Data extraction and quality assessment
Using a standardised extraction form, data from each included study were independently extracted by two reviewers (GM and MP) and consensus used to resolve any disagreement. The following information from each study was extracted: participants’ characteristics (age, stenosis duration and diagnosis criteria), type of surgery and outcome measure. Primary outcomes of interest were pain (e.g., back pain, leg pain, overall pain), disability (e.g., Oswestry Disability Index, walking ability), quality of life, and recovery. Quality of life measures of our interest included for example total scores of the 36-item short-form health survey (SF-36) or from the EuroQol questionnaire. However, none of the trials included in our review reported the total scores of these measures. Instead, they reported scores for the sub-items (e.g., Physical Function or Physical Component Scores) and therefore could not be included in our analyses. Recovery was measured using the differences between preoperative and postoperative Japanese Orthopaedic Association (JOA) scores and reported in the included trials. Secondary outcomes included perioperative surgical data (e.g., blood loss, operation time, length of hospitalisation), complications, reoperations, and costs. To enable cross-trial comparisons, terms used to describe surgical complications were coded based on previously established standard definitions for common complications post spine surgery [28]. We extracted sample sizes, means (final values) and standard deviations for continuous outcomes, and number of cases for dichotomous outcomes. If trials reported incomplete data, authors were contacted for further information. If authors were unavailable, missing data were imputed according to recommendations in the Cochrane Handbook for Systematic Reviews of Interventions [29].
We used the Physiotherapy Evidence Database (PEDro) scale to assess the methodological quality of the included studies. The PEDro scale is widely used to assess the quality of clinical trials in various areas of medicine [30], and consists of an 11-item checklist that has been shown to be a valid and reliable tool [31, 32]. Two raters (GM and MR) independently assessed the methodological quality of each included study and a third author resolved any disagreement. Trials were considered to be of high methodological quality when the PEDro final score was ≥6 points.
Data synthesis and analysis
All data on leg pain, back pain or overall pain were extracted from included trials. If trials reported more than one measure of pain intensity (e.g., back and leg pain), the more severe measure at baseline was included in the analyses. Pain and disability outcome measures were converted to scales from 0 (no pain or disability) to 100 (worst possible pain or disability). For data synthesis, follow-up times were categorized as short-term (less than 12 months) and long-term (12 months or more). If studies reported multiple time points within each category, the time point closest to three months for the short-term, and 12 months for the long-term were used. When more than one scale to measure pain or disability was reported, the one cited by the authors as the primary outcome was used. When studies reported results for more than two intervention groups, we combined similar groups according to the recommendations in the Cochrane Handbook [29].
Trials were grouped according to type of surgery comparison, outcomes, and assessment time points. We used a random-effects model to calculate mean differences (MD) and 95% confidence intervals (CI) for continuous measures. For dichotomous outcomes, risk ratio (RR) and 95% CI was used. Descriptive and inferential statistics were used to present complication and reoperation rates, with a significance level at 5%. The I2 statistic was used to assess heterogeneity between trials, and values higher than 50% were defined to identify high heterogeneity [33]. Comprehensive Meta-Analysis version 2.2.064 (Englewood, NJ, USA, 2011) was used for all analyses.
Grading the evidence and applicability
The GRADE (Grading of Recommendations Assessment, Development and Evaluation) system was used to assess the overall quality of the evidence and strength of recommendations for each outcome measure [34]. The quality of evidence was downgraded by one level according to the following criteria: limitation of study design (> 25% of the studies with low methodological quality [PEDro score < 6]), inconsistency of results (statistically significant heterogeneity [I2 > 50%] or ≤ 75% of trials with findings in the same direction), and imprecision (wide confidence intervals or total number of participants < 300 for each pooled analysis). The indirectness criterion was not considered in this review because we included a specific population with relevant outcomes and direct comparisons. Where only single trials were available, evidence from studies with < 300 participants was downgraded for inconsistency and imprecision and rated as “low quality” evidence. They could be further downgraded to “very low quality” evidence if limitations of study design were found. The quality of evidence was defined as: “high quality”, “moderate quality”, “low quality”, and “very low quality” [34].
Results
Study characteristics
A total of 7,284 records were identified. After excluding duplicates 5,148 titles and abstracts were reviewed, and 168 full text records were assessed. Of these, 19 published reports (17 randomised controlled trials) remained eligible for inclusion in our review [9–11, 35–50]. Flow chart diagram of included studies with the main reasons for exclusion are shown in Fig 1. Two records reported results from the same trial, a subgroup analysis and overall results [48, 49]. Therefore, only the full report was included in our analysis. One trial was published in English as well as in German [9, 50], and as they reported similar results we included the English publication in our analyses. All remaining trials included in this review were published in English and therefore no translation was required.
RCT = randomised controlled trial. *Number of citations includes duplicates.
Participant characteristics
The 17 included trials investigated a total of 1,554 patients and most studies defined lumbar spinal stenosis based on clinical assessment with a concordant imaging diagnosis [9–11, 36–38, 40–47, 49]. One study included patients based solely on imaging diagnosis [35], and another study used clinical assessment only [39]. Fourteen out of 17 trials (82%) explicitly reported including only patients who had failed to improve with conservative treatment [9–11, 36–38, 40–43, 45–47, 49]. The characteristics of included studies and participants are described in Table 1.
Quality assessment
The methodological quality of the included trials revealed a mean score of 5.5 (standard deviation 1.8) using the PEDro scale (range, 0 to 10 score). The most common methodological flaws were lack of blinding (therapist, patient and assessor) and failure to use an intention-to-treat analysis. The three studies that blinded the patients reported that all patients gave informed consent and only one trial described that patients were informed about the operation, timing, and potential complications before the procedure [37, 46, 49]. Only half of the included trials reported concealed allocation (Fig 2). Full details of the final PEDro score for each trial is presented in S2 Table. Given the small number of trials included in each meta-analysis, small study bias analysis was not possible.
PEDro = Physiotherapy Evidence Database.
Interventions
No trials comparing surgery to no treatment or placebo/sham were identified. Therefore, all included trials compared different types of surgical techniques for lumbar spinal stenosis. Quality of evidence assessment and summary of findings, as well as the results of perioperative surgical outcomes (operation time, blood loss, and hospitalisation) are shown in Table 2. Pooled effect sizes for pain and disability at both short and long-term follow-up are presented in Figs 3 and 4.
*Decompression technique is laminectomy or laminotomy.
*Decompression technique is laminectomy or laminotomy
Decompression v Decompression plus fusion
The addition of fusion to bony decompression was investigated in three randomised trials reporting data from 133 patients at long-term follow-up [9, 44, 45]. Pooled analysis showed “very low quality” evidence of nonsignificant difference between treatment groups on pain reduction (MD—3.7, 95% CI—15.6 to 8.1). One trial revealed “low quality” evidence of no between-group difference for disability (MD 9.8, 95% CI—9.4 to 28.9). Two trials evaluated the effectiveness of decompression plus fusion compared to decompression alone on walking ability (i.e., patients were considered improved when able to increase their walking distance by 50% at follow-up). The analysis provided “very low quality” evidence of no difference on walking ability between groups (RR 0.9, 95% CI 0.4 to 1.9). Mean direct surgery costs was higher for patients treated by decompression plus fusion (USD $16,115) compared to decompression alone (USD $10,392). However, no inferential statistics were reported for this outcome.
Laminectomy v Laminotomy
Six randomised controlled trials reporting data from 475 patients compared laminectomy to unilateral [10, 36, 38, 39], and bilateral laminotomies [35–37]. For pain, we found “low quality” evidence that laminotomy is not superior to laminectomy at short-term (MD—0.4, 95% CI—4.3 to 3.5) and long-term follow-up (MD 1.7, 95% CI—4.4 to 7.8). Likewise, “high” to “moderate quality” evidence revealed that laminotomy failed to show disability reduction when compared to laminectomy at short-term (MD 1.6, 95% CI—1.0 to 4.2) and long-term follow-up (MD 1.1, 95% CI—1.7 to 3.8). For short-term walking ability (i.e., walking distance in metres without radicular pain), there is “very low quality” evidence that laminotomy is not superior to laminectomy (MD—7.6, 95% CI—37.4 to 22.3), and “moderate quality” evidence of no difference at long-term follow-up (MD—3.0, 95% CI—32.7 to 26.7).
Laminectomy v Split–laminectomy/laminotomy
Three trials reported data of 148 patients treated with bony decompression by laminectomy or with spinous process split–laminectomy/laminotomy at long-term follow-up [39–41]. Pooling showed no statistically significant difference between treatments for pain (MD 2.3, 95% CI—3.8 to 8.4) and disability (MD—1.0, 95% CI—4.8 to 2.9). We also found no difference on long-term recovery rate (MD 2.1, 95% CI—5.7 to 9.8) assessed by the Japanese Association Score (range, 0 to 100). The overall quality of evidence was rated as “very low quality” for all three outcomes, according to the GRADE criteria.
Laminectomy/laminotomy v Endoscopic–laminectomy/laminotomy
The effectiveness of endoscopic–assisted laminectomy/laminotomy was investigated in two randomised trials including 233 patients [42, 43]. Pooling revealed “low quality” evidence of no significant effect of endoscopic approaches compared to conventional laminectomy/laminotomy on disability at short-term (MD 5.2, 95% CI—2.2 to 12.5), and long-term follow-up (MD 3.1, 95% CI—0.7 to 7.0). Pain intensity was not reported in these two studies.
Laminectomy/laminotomy v Interspinous process spacer device
Two high methodological quality trials reported data of 259 patients comparing bony decompression by laminectomy or laminotomies to the X-Stop and Coflex interspinous process spacer devices [11, 46]. At short-term follow-up, “moderate quality” evidence showed no difference on pain reduction (MD—4.8, 95% CI—11.1 to 1.5). Likewise, “low quality” evidence revealed no long-term difference on pain between groups (MD—2.4, 95% CI—13.6 to 8.9). For disability, “low quality evidence” did not reveal any difference at short-term (MD—0.4, 95% CI—6.9 to 6.2) and long-term follow-up (MD—0.8, 95% CI—8.4 to 6.7). Additionally, one study showed “low quality” evidence of no benefit of interspinous spacers compared to decompression on walking ability (i.e., ability to walk 1200 m within 15 minutes or increase of 80 m compared to baseline walking distance) at short-term (OR 0.8, 95% CI 0.4 to 1.3) and long-term follow-up (OR 1.3, 95% CI 0.9 to 1.8).
Decompression plus fusion v Interspinous process spacer device
Two trials compared decompression plus fusion to the X-Stop and Coflex devices [47, 49], including a total of 382 patients analysed at long-term follow-up only. There is “moderate quality” evidence of no difference between groups on pain reduction (MD 5.3, 95% CI—1.1 to 11.6). However, we found “moderate quality” evidence that interspinous spacers are slightly superior to decompression plus fusion on disability outcomes in the long-term (MD 5.7, 95% CI 1.3 to 10.0).
Adverse events and reoperations
We found high variability in the number of reported adverse events across surgical techniques, with rates ranging from 4% to 45%. Trials reported a wide variety of minor and major surgical adverse events, ranging from transient urinary retention to cerebrovascular accident. Overall, reoperation rates ranged from 3% to 28%, with the interspinous process spacer devices revealing the highest rates.
“Very low” and “low quality” evidence revealed that patients undergoing decompression plus fusion had an overall higher rate of adverse events (20/64, 31% v 3/24, 13%; P = 0.07) and reoperations (9/92, 10% v 1/37, 3%; P = 0.47) when compared to decompression alone. This difference was not statistically significant, however. “Moderate quality” evidence showed that laminectomy had nonsignificant higher adverse events (23/154, 15% v 19/192, 10%; P = 0.60) and reoperations rates (6/68, 9% v 4/114, 4%; P = 0.12) than the minimally invasive laminotomies. We found “low” and “very low quality” evidence that conventional laminectomy revealed nonsignificant higher adverse event (3/23, 13% v 1/28, 4%, P = 0.25) and reoperation rates (1/38, 3% v 1/45, 2%, P = 0.90) than the spinous process splitting techniques. There is “very low quality” evidence that laminectomy/laminotomy result in significantly higher adverse event rates (16/100, 16% v 5/92, 5%; P = 0.03) than the endoscopic techniques. However, no difference in reoperation rates was observed (2/80, 3% v 3/81, 4%; P = 0.66). In trials investigating the effectiveness of interspinous process spacer devices, we found “moderate quality” evidence that bony decompression is not associated with higher adverse events (9/129, 7% v 6/130, 5%; P = 0.74). However, interspinous process spacers revealed a significantly higher reoperation rate (34/123, 28% v 9/122, 7%; P < 0.001). Trials comparing decompression plus fusion to interspinous process spacer devices reported similar rates of adverse events for both techniques (45%), and “low quality” evidence revealed no difference in rates of revision surgery (23/215, 11% v 8/107, 7%; P = 0.36).
Discussion
The results of this systematic review have revealed a paucity of evidence on the efficacy of surgery for lumbar spinal stenosis, to date there are no published randomised controlled trials comparing surgery to no treatment or placebo/sham surgery. Placebo-controlled trials in surgery are feasible and powerful to show the efficacy of surgical procedures [51]. Therefore, we identified 17 published randomised trials that reported the comparative effectiveness of different surgical techniques. Our results show that overall there is no difference in the effectiveness among the most commonly used surgical techniques for lumbar spinal stenosis. More importantly, we have demonstrated that the addition of fusion to traditional decompression for the treatment of lumbar spinal stenosis adds no benefit in terms of pain or disability. We found that the interspinous process spacer devices showed better outcomes (disability, operation time, blood loss, and hospitalisation) compared to decompression plus fusion. However, interspinous spacers have significantly higher reoperation rates than bony decompression.
There are several strengths to our review. We have used a prespecified registered protocol, performed a sensitive electronic search on seven different databases, and selected studies with no restrictions for language or publication date. To our knowledge, this is the first review to objectively estimate the effectiveness amongst all surgical techniques for lumbar spinal stenosis focusing on patient-related outcomes, whereas past reviews performed pooled analysis based on surgeon-related outcomes (i.e., the effectiveness of a surgical technique was rated by the surgeon) [16]. Our review included only randomised clinical trials, as causal inference of treatment on clinical outcomes can only be made when patients are truly randomised to treatment groups [52]. A further limitation of past reviews is that many have drawn conclusions based on non-randomised trials (i.e., indirect comparisons, observational studies and case series) [53–55]. Although it is debatable whether meta-analysis from randomised trials can provide accurate estimates about harms of medical interventions [56, 57], this is the first review to assess the safety of all surgical techniques for lumbar spinal stenosis by investigating reported adverse events, reoperation rates, perioperative blood loss, operation time, and length of hospitalisation.
Our review has identified important weaknesses in the literature. Overall, the methodological quality of included studies was poor. Whereas blinding of the caregiver in surgical trials is typically not possible, only six trials reported blinding of outcome assessors and three studies reported that patients were blinded. The reporting of data was also poor among some included studies, and we had to estimate the treatment effect from graphs or by adopting data (e.g., standard deviation) from similar studies. We recommend that future trials follow the CONSORT statement when reporting randomised controlled trials [58]. The safety of surgical interventions also varied largely across studies and not all trials have reported the numbers of adverse events or reoperations. Therefore, it is possible we have underestimated the rates of complications and reoperations and alert that our conclusions on harms of included interventions should be interpreted with caution. Future studies should be more thorough in reporting these surgical outcomes [59]. Another limitation of our study is the inclusion of few studies in each meta-analysis and the variability of techniques used by surgeons.
We found no trials investigating the efficacy of surgery for lumbar spinal stenosis compared to placebo/sham surgery. Therefore its true efficacy rather than the effect of the patient's expectation of the surgical intervention (placebo effect) remains unknown. Given the amount of surgical techniques for the treatment of lumbar spinal stenosis the need for placebo/sham-controlled trials has never been greater. Previous work has proposed the appropriate ethical considerations for sham surgery [60], and demonstrated that placebo/sham-controlled trials in surgery are feasible [51]. For instance, sham-controlled trials have been recently published in investigating the efficacy of vertebroplasty for painful osteoporotic vertebral fractures [61]. In these trials, sham surgery was performed by inserting a blunt stylet and gently tapping the vertebral body. Likewise, Flum has suggested performing minimally invasive approaches to the spine, simulating the decompressive technique, but without actually removing any bone tissue [62]. The addition of fusion to decompression for spinal stenosis has been previously investigated in systematic reviews with conflicting conclusions [63, 64]. We have identified three randomised trials comparing decompression alone to decompression plus fusion, and our results revealed no significant differences between treatment groups on clinical outcomes. In fact, decompression plus fusion revealed significantly higher intraoperative blood loss when compared to decompression alone. These findings are based on “low” to “very low” quality evidence, however. One high quality trial revealed a cost difference of approximately USD $6,290 per patient for an additional fusion implant [45]. Therefore, the superiority of decompression plus fusion to decompression alone is still uncertain and surgeons should choose between these techniques with caution, especially considering the associated costs and perioperative complications of fusion. A systematic review has also investigated the effectiveness of interspinous process spacer devices for spinal stenosis, suggesting that spacer devices are superior to bony decompression [54]. However, this result was based on indirect comparisons through a network meta-analysis. Similarly, a second systematic review has failed to identify trials directly comparing these two techniques [53]. More recently, Wu et al reported results from meta-analyses that included both randomised and non-randomised studies [65]. In our review, pooling of two high methodological quality randomised trials has revealed no difference between treatments on pain, disability, or walking ability. Although the spacer devices showed significantly less operation time, they resulted in higher numbers of revision surgeries. Therefore, due to lack of effectiveness and higher reoperation rates of interspinous process devices compared to bony decompression, the recommendation for the use of decompressive devices is debatable.
Conclusions
In conclusion, there is relatively limited evidence to guide the use of surgery for the management of lumbar spinal stenosis. Overall, the quality of the available evidence ranged from “high” to “very low” revealing nonsignificant differences across surgical techniques for lumbar spinal stenosis, and a small, but clinically debatable, benefit of interspinous spacer devices compared to decompression plus fusion. The addition of fusion to decompression is more costly, leads to more intraoperative blood loss, and fails to promote superior outcomes if compared to decompression alone. Although the operation using interspinous spacers is quicker, these devices are more expensive than conventional bony decompression and are associated with higher revision surgeries. We, therefore, question the use of decompression plus fusion and the safety of interspinous spacers in the management of patients with lumbar spinal stenosis. More high quality trials comparing the effectiveness between techniques are needed to support our findings. Patients and clinicians could use this review as an evidence-based tool to help decide the best surgical option for this condition.
Supporting Information
S2 Table. Risk of Bias (PEDro) of Included Studies.
PEDro = Physiotherapy Evidence Database.
https://doi.org/10.1371/journal.pone.0122800.s003
(DOCX)
Author Contributions
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.
References
- 1. Ishimoto Y, Yoshimura N, Muraki S, Yamada H, Nagata K, Hashizume H, et al. Associations between radiographic lumbar spinal stenosis and clinical symptoms in the general population: the Wakayama Spine Study. Osteoarthritis Cartilage. 2013; 21: 783–788. pmid:23473979
- 2. Benoist M. The natural history of lumbar degenerative spinal stenosis. Joint Bone Spine. 2002; 69: 450–457. pmid:12477228
- 3.
Johnsson KE, Rosen I, Uden A. The natural course of lumbar spinal stenosis. Clin Orthop Relat Res. 1992: 82–86.
- 4. You JJ, Bederman SS, Symons S, Bell CM, Yun L, Laupacis A, et al. Patterns of care after magnetic resonance imaging of the spine in primary care. Spine. 2013; 38: 51–59. pmid:22652596
- 5. Deyo RA, Gray DT, Kreuter W, Mirza S, Martin BI. United States trends in lumbar fusion surgery for degenerative conditions. Spine. 2005; 30: 1441–1445; discussion 1446–1447. pmid:15959375
- 6. Deyo RA, Mirza SK, Martin BI, Kreuter W, Goodman DC, Jarvik JG. Trends, major medical complications, and charges associated with surgery for lumbar spinal stenosis in older adults. JAMA. 2010; 303: 1259–1265. pmid:20371784
- 7. Davis H. Increasing rates of cervical and lumbar spine surgery in the United States, 1979–1990. Spine. 1994; 19: 1117–1123; discussion 1123–1114. pmid:8059266
- 8. Ciol MA, Deyo RA, Howell E, Kreif S. An assessment of surgery for spinal stenosis: time trends, geographic variations, complications, and reoperations. J Am Geriatr Soc. 1996; 44: 285–290. pmid:8600197
- 9. Grob D, Humke T, Dvorak J. Degenerative lumbar spinal stenosis. Decompression with and without arthrodesis. J Bone Joint Surg Am 1995; 77: 1036–1041. pmid:7608225
- 10. Cavusoglu H, Turkmenoglu O, Kaya RA, Tuncer C, Colak I, Sahin Y, et al. Efficacy of unilateral laminectomy for bilateral decompression in lumbar spinal stenosis. Turk Neurosurg. 2007; 17: 100–108. pmid:17935024
- 11. Stromqvist BH, Berg S, Gerdhem P, Johnsson R, Moller A, Sahlstrand T, et al. X-stop versus decompressive surgery for lumbar neurogenic intermittent claudication: Randomized controlled trial with 2-year follow-up. Spine. 2013; 38: 1436–1442. pmid:23403549
- 12. Kovacs FM, Urrútia G, Alarcón JD. Surgery versus conservative treatment for symptomatic lumbar spinal stenosis: a systematic review of randomized controlled trials. Spine. 2011; 36: E1335–1351. pmid:21311394
- 13. May S, Comer C. Is surgery more effective than non-surgical treatment for spinal stenosis, and which non-surgical treatment is more effective? A systematic review. Physiotherapy. 2013; 99: 12–20. pmid:23219644
- 14. Weinstein JN, Tosteson TD, Lurie JD, Tosteson ANA, Blood E, Hanscom B, et al. Surgical versus nonsurgical therapy for lumbar spinal stenosis. N Engl J Med. 2008; 358: 794–810. pmid:18287602
- 15. Jansson KA, Blomqvist P, Granath F, Nemeth G. Spinal stenosis surgery in Sweden 1987–1999. Eur Spine J. 2003; 12: 535–541. pmid:12768381
- 16. Gibson JN, Waddell G. Surgery for degenerative lumbar spondylosis: updated Cochrane Review. Spine. 2005; 30: 2312–2320. pmid:16227895
- 17. Stromqvist F, Jonsson B, Stromqvist B, Swedish Society of Spinal Surgeons. Dural lesions in decompression for lumbar spinal stenosis: incidence, risk factors and effect on outcome. Eur Spine J. 2012; 21: 825–828. pmid:22146791
- 18. Aryanpur J, Ducker T. Multilevel lumbar laminotomies for focal spinal stenosis: case report. Neurosurgery. 1988; 23: 111–115. pmid:2971890
- 19. Spetzger U, Bertalanffy H, Reinges MHT, Gilsbach JM. Unilateral laminotomy for bilateral decompression of lumbar spinal stenosis. Part II: Clinical experiences. Acta Neurochir (Wien). 1997; 139: 397–403. pmid:9204107
- 20. Spetzger U, Bertalanffy H, Naujokat C, von Keyserlingk DG, Gilsbach JM. Unilateral laminotomy for bilateral decompression of lumbar spinal stenosis. Part I: Anatomical and surgical considerations. Acta Neurochir (Wien). 1997; 139: 392–396. pmid:9204106
- 21. Watanabe K, Hosoya T, Shiraishi T, Matsumoto M, Chiba K, Toyama Y. Lumbar spinous process-splitting laminectomy for lumbar canal stenosis. Technical note. J Neurosurg Spine. 2005; 3: 405–408. pmid:16302638
- 22. Johnsson KE, Redlund-Johnell I, Uden A, Willner S. Preoperative and postoperative instability in lumbar spinal stenosis. Spine. 1989; 14: 591–593. pmid:2749373
- 23. Nasca RJ. Rationale for spinal fusion in lumbar spinal stenosis. Spine. 1989; 14: 451–454. pmid:2718051
- 24. Taylor VM, Deyo RA, Cherkin DC, Kreuter W. Low back pain hospitalization. Recent United States trends and regional variations. Spine. 1994; 19: 1207–1212; discussion 1213. pmid:8073311
- 25. Deyo RA, Martin BI, Ching A, Tosteson AN, Jarvik JG, Kreuter W, et al. Interspinous spacers compared with decompression or fusion for lumbar stenosis: complications and repeat operations in the medicare population. Spine. 2013; 38: 865–872. pmid:23324936
- 26. Katz JN, Lipson SJ, Lew RA, Grobler LJ, Weinstein JN, Brick GW, et al. Lumbar laminectomy alone or with instrumented or noninstrumented arthrodesis in degenerative lumbar spinal stenosis. Patient selection, costs, and surgical outcomes. Spine. 1997; 22: 1123–1131. pmid:9160471
- 27. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gotzsche PC, Ioannidis JP, et al. The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009; 339: b2700. pmid:19622552
- 28. Mirza SK, Deyo RA, Heagerty PJ, Turner JA, Lee LA, Goodkin R. Towards standardized measurement of adverse events in spine surgery: conceptual model and pilot evaluation. BMC Musculoskelet Disord. 2006; 7: 53. pmid:16787537
- 29.
Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, 2011. Available from www.cochrane-handbook.org.: The Cochrane Collaboration.
- 30. Elkins MR, Moseley AM, Sherrington C, Herbert RD, Maher CG. Growth in the Physiotherapy Evidence Database (PEDro) and use of the PEDro scale. Br J Sports Med. 2013; 47: 188–189. pmid:23134761
- 31. Maher CG, Sherrington C, Herbert RD, Moseley AM, Elkins M. Reliability of the PEDro scale for rating quality of randomized controlled trials. Phys Ther. 2003; 83: 713–721. pmid:12882612
- 32. de Morton NA. The PEDro scale is a valid measure of the methodological quality of clinical trials: a demographic study. Aust J Physiother. 2009; 55: 129–133. pmid:19463084
- 33. Higgins JP, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002; 21: 1539–1558. pmid:12111919
- 34. Guyatt GH, Oxman AD, Vist GE, Kunz R, Falck-Ytter Y, Alonso-Coello P, et al. GRADE: an emerging consensus on rating quality of evidence and strength of recommendations. BMJ. 2008; 336: 924–926. pmid:18436948
- 35. Postacchini F, Cinotti G, Perugia D, Gumina S. The surgical treatment of central lumbar stenosis. Multiple laminotomy compared with total laminectomy. J Bone Joint Surg Br. 1993; 75: 386–392. pmid:8496205
- 36. Thome C, Zevgaridis D, Leheta O, Bazner H, Pockler-Schoniger C, Wohrle J, et al. Outcome after less-invasive decompression of lumbar spinal stenosis: a randomized comparison of unilateral laminotomy, bilateral laminotomy, and laminectomy. J Neurosurg Spine. 2005; 3: 129–141. pmid:16370302
- 37. Celik SE, Celik S, Goksu K, Kara A, Ince I. Microdecompressive laminatomy with a 5-year follow-up period for severe lumbar spinal stenosis. J Spinal Disord Tech. 2010; 23: 229–235. pmid:20526152
- 38. Gurelik M, Bozkina C, Kars Z, Karadag O, Unal O, Bayrakli F. Unilateral laminotomy for decompression of lumbar stenosis is effective and safe: A prospective randomized comparative study. J Neurol Sci. 2012; 29: 744–753.
- 39. Liu X, Yuan S, Tian Y. Modified unilateral laminotomy for bilateral decompression for lumbar spinal stenosis: Technical note. Spine. 2013; 38: E732–E737. pmid:23466507
- 40. Watanabe K, Matsumoto M, Ikegami T, Nishiwaki Y, Tsuji T, Ishii K, et al. Reduced postoperative wound pain after lumbar spinous process-splitting laminectomy for lumbar canal stenosis: A randomized controlled study. Clinical article. J Neurosurg Spine. 2011; 14: 51–58. pmid:21142464
- 41. Rajasekaran S, Thomas A, Kanna RM, Shetty AP. Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis: A prospective, randomised controlled study of 51 patients. Spine. 2013; 38: 1737–1743. pmid:23797498
- 42. Ruetten S, Komp M, Merk H, Godolias G. Surgical treatment for lumbar lateral recess stenosis with the full-endoscopic interlaminar approach versus conventional microsurgical technique: A prospective, randomized, controlled study—Clinical article. J Neurosurg Spine. 2009; 10: 476–485. pmid:19442011
- 43. Yagi M, Okada E, Ninomiya K, Kihara M. Postoperative outcome after modified unilateral-approach microendoscopic midline decompression for degenerative spinal stenosis: Clinical article. J Neurosurg Spine. 2009; 10: 293–299. pmid:19441985
- 44. Bridwell KH, Sedgewick TA, O'Brien MF, Lenke LG, Baldus C. The role of fusion and instrumentation in the treatment of degenerative spondylolisthesis with spinal stenosis. J Spinal Disord. 1993; 6: 461–472. pmid:8130395
- 45. Hallett A, Huntley JS, Gibson JN. Foraminal stenosis and single-level degenerative disc disease: a randomized controlled trial comparing decompression with decompression and instrumented fusion. Spine. 2007; 32: 1375–1380. pmid:17545903
- 46. Moojen WA, Arts MP, Jacobs WC, van Zwet EW, van den Akker-van Marle ME, Koes BW, et al. Interspinous process device versus standard conventional surgical decompression for lumbar spinal stenosis: randomized controlled trial. BMJ. 2013; 347: f6415. pmid:24231273
- 47. Azzazi A, Elhawary Y. Dynamic stabilization using X-stop versus transpedicular screw fixation in the treatment of lumbar canal stenosis: comparative study of the clinical outcome. Neurosurg Q. 2010; 20: 165–169.
- 48. Davis R, Auerbach JD, Bae H, Errico TJ. Can low-grade spondylolisthesis be effectively treated by either coflex interlaminar stabilization or laminectomy and posterior spinal fusion Two-year clinical and radiographic results from the randomized, prospective, multicenter US investigational device exemption trial: Clinical article. J Neurosurg Spine. 2013; 19: 174–184. pmid:23725394
- 49. Davis RJ, Errico TJ, Bae H, Auerbach JD. Decompression and coflex interlaminar stabilization compared with decompression and instrumented spinal fusion for spinal stenosis and low-grade degenerative spondylolisthesis: Two-year results from the prospective, randomized, multicenter, food and drug administration investigational device exemption trial. Spine. 2013; 38: 1529–1539. pmid:23680830
- 50. Grob D, Humke T, Dvorak J. Surgical decompression of degenerative lumbar spinal stenosis with and without fusion. Orthopade. 1993; 22: 243–249. pmid:8414481
- 51. Wartolowska K, Judge A, Hopewell S, Collins GS, Dean BJ, Rombach I, et al. Use of placebo controls in the evaluation of surgery: systematic review. BMJ. 2014; 348: g3253. pmid:24850821
- 52. Rubin DB. Formal modes of statistical inference for causal effects. Journal of Statistical Planning and Inference. 1990; 25: 279–292.
- 53. Moojen WA, Arts MP, Bartels RH, Jacobs WC, Peul WC. Effectiveness of interspinous implant surgery in patients with intermittent neurogenic claudication: a systematic review and meta-analysis. Eur Spine J. 2011; 20: 1596–1606. pmid:21667130
- 54. Chou D, Lau D, Hermsmeyer J, Norvell D. Efficacy of interspinous device versus surgical decompression in the treatment of lumbar spinal stenosis: a modified network analysis. Evid Based Spine Care J. 2011; 2: 45–56. pmid:23230405
- 55. Turner JA, Ersek M, Herron L, Deyo R. Surgery for lumbar spinal stenosis. Attempted meta-analysis of the literature. Spine. 1992; 17: 1–8. pmid:1531550
- 56. Golder S, Loke YK, Bland M. Meta-analyses of adverse effects data derived from randomised controlled trials as compared to observational studies: methodological overview. PLoS Med. 2011; 8: e1001026. pmid:21559325
- 57. Papanikolaou PN, Christidi GD, Ioannidis JP. Comparison of evidence on harms of medical interventions in randomized and nonrandomized studies. CMAJ. 2006; 174: 635–641. pmid:16505459
- 58. Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010; 340: c332. pmid:20332509
- 59. Ioannidis JP, Evans SJ, Gotzsche PC, O'Neill RT, Altman DG, Schulz K, et al. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004; 141: 781–788. pmid:15545678
- 60. Horng S, Miller FG. Ethical framework for the use of sham procedures in clinical trials. Crit Care Med. 2003; 31: S126–130. pmid:12626957
- 61. Buchbinder R, Osborne RH, Ebeling PR, Wark JD, Mitchell P, Wriedt C, et al. A randomized trial of vertebroplasty for painful osteoporotic vertebral fractures. N Engl J Med. 2009; 361: 557–568. pmid:19657121
- 62. Flum DR. Interpreting surgical trials with subjective outcomes: avoiding UnSPORTsmanlike conduct. JAMA. 2006; 296: 2483–2485. pmid:17119146
- 63. Martin CR, Gruszczynski AT, Braunsfurth HA, Fallatah SM, O'Neil J, Wai EK. The surgical management of degenerative lumbar spondylolisthesis: a systematic review. Spine. 2007; 32: 1791–1798. pmid:17632401
- 64. Resnick DK, Choudhri TF, Dailey AT, Groff MW, Khoo L, Matz PG, et al. Guidelines for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 9: fusion in patients with stenosis and spondylolisthesis. Journal of Neurosurgery Spine. 2005; 2: 679–685. pmid:16028737
- 65. Wu AM, Zhou Y, Li QL, Wu XL, Jin YL, Luo P, et al. Interspinous spacer versus traditional decompressive surgery for lumbar spinal stenosis: a systematic review and meta-analysis. PLoS One. 2014; 9: e97142. pmid:24809680