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Surgical versus nonsurgical therapy for lumbar spinal stenosis.

ABSTRACT: Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary outcomes were measures of bodily pain and physical function on the Medical Outcomes Study 36-item Short-Form General Health Survey (SF-36) and the modified Oswestry Disability Index at 6 weeks, 3 months, 6 months, and 1 and 2 years.A total of 289 patients were enrolled in the randomized cohort, and 365 patients were enrolled in the observational cohort. At 2 years, 67% of patients who were randomly assigned to surgery had undergone surgery, whereas 43% of those who were randomly assigned to receive nonsurgical care had also undergone surgery. Despite the high level of nonadherence, the intention-to-treat analysis of the randomized cohort showed a significant treatment effect favoring surgery on the SF-36 scale for bodily pain, with a mean difference in change from baseline of 7.8 (95% confidence interval, 1.5 to 14.1); however, there was no significant difference in scores on physical function or on the Oswestry Disability Index. The as-treated analysis, which combined both cohorts and was adjusted for potential confounders, showed a significant advantage for surgery by 3 months for all primary outcomes; these changes remained significant at 2 years.In the combined as-treated analysis, patients who underwent surgery showed significantly more improvement in all primary outcomes than did patients who were treated nonsurgically. (ClinicalTrials.gov number, NCT00000411 [ClinicalTrials.gov].).

SUBMITTER: Weinstein JN

PROVIDER: S-EPMC2576513 | biostudies-literature | 2008 Feb

REPOSITORIES: biostudies-literature

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Surgical versus nonsurgical therapy for lumbar spinal stenosis.

Weinstein James N JN Tosteson Tor D TD Lurie Jon D JD Tosteson Anna N A AN Blood Emily E Hanscom Brett B Herkowitz Harry H Cammisa Frank F Albert Todd T Boden Scott D SD Hilibrand Alan A Goldberg Harley H Berven Sigurd S An Howard H

The New England journal of medicine 20080201 8

<h4>Background</h4>Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.<h4>Methods</h4>Surgical candidates with a history of at least 12 weeks of symptoms and spinal stenosis without spondylolisthesis (as confirmed on imaging) were enrolled in either a randomized cohort or an observational cohort at 13 U.S. spine clinics. Treatment was decompressive surgery or usual nonsurgical care. The primary out ...[more]

PMID: 18287602

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Project description:Management of degenerative spondylolisthesis with spinal stenosis is controversial. Surgery is widely used, but its effectiveness in comparison with that of nonsurgical treatment has not been demonstrated in controlled trials.Surgical candidates from 13 centers in 11 U.S. states who had at least 12 weeks of symptoms and image-confirmed degenerative spondylolisthesis were offered enrollment in a randomized cohort or an observational cohort. Treatment was standard decompressive laminectomy (with or without fusion) or usual nonsurgical care. The primary outcome measures were the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) bodily pain and physical function scores (100-point scales, with higher scores indicating less severe symptoms) and the modified Oswestry Disability Index (100-point scale, with lower scores indicating less severe symptoms) at 6 weeks, 3 months, 6 months, 1 year, and 2 years.We enrolled 304 patients in the randomized cohort and 303 in the observational cohort. The baseline characteristics of the two cohorts were similar. The one-year crossover rates were high in the randomized cohort (approximately 40% in each direction) but moderate in the observational cohort (17% crossover to surgery and 3% crossover to nonsurgical care). The intention-to-treat analysis for the randomized cohort showed no statistically significant effects for the primary outcomes. The as-treated analysis for both cohorts combined showed a significant advantage for surgery at 3 months that increased at 1 year and diminished only slightly at 2 years. The treatment effects at 2 years were 18.1 for bodily pain (95% confidence interval [CI], 14.5 to 21.7), 18.3 for physical function (95% CI, 14.6 to 21.9), and -16.7 for the Oswestry Disability Index (95% CI, -19.5 to -13.9). There was little evidence of harm from either treatment.In nonrandomized as-treated comparisons with careful control for potentially confounding baseline factors, patients with degenerative spondylolisthesis and spinal stenosis treated surgically showed substantially greater improvement in pain and function during a period of 2 years than patients treated nonsurgically. (ClinicalTrials.gov number, NCT00000409 [ClinicalTrials.gov].).

Project description:Importance:Lumbar spinal stenosis (LSS) is the most common reason for spine surgery in older US adults. There is an evidence gap about nonsurgical LSS treatment options. Objective:To explore the comparative clinical effectiveness of 3 nonsurgical interventions for patients with LSS. Design, Setting, and Participants:Three-arm randomized clinical trial of 3 years' duration (November 2013 to June 2016). Analysis began in August 2016. All interventions were delivered during 6 weeks with follow-up at 2 months and 6 months at an outpatient research clinic. Patients older than 60 years with LSS were recruited from the general public. Eligibility required anatomical evidence of central canal and/or lateral recess stenosis (magnetic resonance imaging/computed tomography) and clinical symptoms associated with LSS (neurogenic claudication; less symptoms with flexion). Analysis was intention to treat. Interventions:Medical care, group exercise, and manual therapy/individualized exercise. Medical care consisted of medications and/or epidural injections provided by a physiatrist. Group exercise classes were supervised by fitness instructors in senior community centers. Manual therapy/individualized exercise consisted of spinal mobilization, stretches, and strength training provided by chiropractors and physical therapists. Main Outcomes and Measures:Primary outcomes were between-group differences at 2 months in self-reported symptoms and physical function measured by the Swiss Spinal Stenosis questionnaire (score range, 12-55) and a measure of walking capacity using the self-paced walking test (meters walked for 0 to 30 minutes). Results:A total of 259 participants (mean [SD] age, 72.4 [7.8] years; 137 women [52.9%]) were allocated to medical care (88 [34.0%]), group exercise (84 [32.4%]), or manual therapy/individualized exercise (87 [33.6%]). Adjusted between-group analyses at 2 months showed manual therapy/individualized exercise had greater improvement of symptoms and physical function compared with medical care (-2.0; 95% CI, -3.6 to -0.4) or group exercise (-2.4; 95% CI, -4.1 to -0.8). Manual therapy/individualized exercise had a greater proportion of responders (?30% improvement) in symptoms and physical function (20%) and walking capacity (65.3%) at 2 months compared with medical care (7.6% and 48.7%, respectively) or group exercise (3.0% and 46.2%, respectively). At 6 months, there were no between-group differences in mean outcome scores or responder rates. Conclusions and Relevance:A combination of manual therapy/individualized exercise provides greater short-term improvement in symptoms and physical function and walking capacity than medical care or group exercises, although all 3 interventions were associated with improvements in long-term walking capacity. Trial Registration:ClinicalTrials.gov Identifier: NCT01943435.

Project description:INTRODUCTION:Symptomatic lumbar spinal stenosis is the most common indication for spinal surgery. However, more than one-third of the patients undergoing surgery for lumbar stenosis report dissatisfaction with the results. On the other hand, conservative treatment has shown positive results in some cases. This trial will compare the outcomes of surgical versus non-surgical treatment for lumbar stenosis. The study includes a multidimensional follow-up, aiming to study the association between outcome and other studied parameters, mainly electromyography and nerve conduction. Moreover, it may contribute to a better understanding of the pathophysiology of lumbar stenosis and to the development of future pharmacological treatments. METHODS AND ANALYSIS:UppSten is a single-centre randomised controlled trial in which 150 patients with symptomatic lumbar spinal stenosis will be randomised into one of two treatment arms. The patients in the surgical arm will undergo laminectomy; the patients in the non-surgical arm will be given a structured physical training programme. The primary outcome of the study will be the Oswestry Disability Index. Secondary outcomes will include motor amplitude and degree of denervation activity obtained by means of nerve conduction studies and electromyography. Patient-reported outcome measures will be also used as secondary outcomes. Blood sample analysis and the investigation of potential inflammation markers are the additional secondary outcome parameters. Laboratory evaluation will include blood sample collection before the treatment initiation and after 6 months. Flavum ligament biopsies will be performed in the surgical group. Finally, tertiary outcomes will include neurophysiological measures, the objective walking ability and radiological evaluation. ETHICS AND DISSEMINATION:The study is approved by the Local Ethics Committee (Dnr 2017-506), the Hospital's Clinical Trials Committee (2018-0001) and the National Biobank Council and Uppsala Biobank (BbA-827-2018-025). The results will be presented in peer-reviewed journals and at international conferences. TRIAL REGISTRATION NUMBER:NCT03495661.

Project description: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.

Project description:Study designSecondary analysis from a randomized controlled trial on nonsurgical interventions for patients with lumbar spinal stenosis (LSS).ObjectiveThe aim of this study was to assess the responsiveness of the Self-Paced Walking Test (SPWT), Swiss Spinal Stenosis Questionnaire (SSS), and Oswestry Disability Index (ODI) and determine their minimal clinically important differences (MCID) in nonsurgical LSS patients.Summary of background dataLimited information is available about the responsiveness of these tests in nonsurgical LSS population.MethodsA total of 180 participants completed the SPWT, SSS, and ODI at baseline, 2, and 6 months. Responsiveness was assessed by distribution-based method, including effect size and standardized response mean, and anchor-based method, using the patient global index of change (PGIC) as the external anchor to distinguish responders and non-responders. Areas under the curve (AUC) were calculated along with MCIDs for "minimal" and "moderate improvement" subgroups.ResultsThe following values represent 2- and 6-month analyses of each outcome measure, respectively. Standard effect sizes: 0.48 and 0.50 for SPWT, -0.42 and -0.36 for SSS, and -0.29 and -0.25 for ODI. Spearman correlation coefficients between PGIC and outcomes were: 0.44 and 0.39 for SPWT, -0.53 and -0.55 for SSS, and -0.46 and -0.54 for ODI. MCIDs for the "minimal improvement" subgroup were: 375.9 and 319.3 ms for SPWT, -5.3 and -5.8 points for SSS, and -9.3 and -10.8 points for ODI. AUCs was 0.68 to 0.76. MCIDs for the "moderate improvement" subgroup were: 344.2 and 538.2 m for SPWT, -5.5 and -7.5 points for SSS, and -9.1 and -13.6 points for ODI. AUCs ranged from 0.68 to 0.76.ConclusionThe SPWT, SSS, and ODI are responsive outcome measures to assess nonsurgical patients with LSS. This finding, along with the reported MCIDs, can help clinicians to monitor changes in their patients' walking and physical function over time and make clinical decisions. They also provide researchers with reference for future studies in LSS.Level of Evidence: 2.

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Surgical versus nonsurgical therapy for lumbar spinal stenosis.

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Surgical versus nonsurgical therapy for lumbar spinal stenosis.

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