Article

Surgical versus Nonsurgical Therapy for Lumbar Spinal Stenosis

Dartmouth Institute for Health Policy and Clinical Practice, Department of Orthopedics, Dartmouth Medical School, Hanover, NH 03756, USA.
New England Journal of Medicine (Impact Factor: 55.87). 03/2008; 358(8):794-810. DOI: 10.1056/NEJMoa0707136
Source: PubMed

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].).

Download full-text

Full-text

Available from: Scott Boden
  • Source
    • "Acetaminophen And Oxycodone 7.5% (10)[11]9.2% (10)[10]0.82 Celecoxib 4.5% (6)[6]0.9% (1)[1]0.20 Meloxicam 3.8% (5)[5]3.7% "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: Patients suffering from neurogenic claudication due to lumbar spinal stenosis (LSS) often experience moderate to severe pain and significant functional disability. Neurogenic claudication results from progressive degenerative changes in the spine, and most often affects the elderly. Both the MILD® procedure and epidural steroid injections (ESIs) offer interventional pain treatment options for LSS patients experiencing neurogenic claudication refractory to more conservative therapies. MILD provides an alternative to ESIs via minimally invasive lumbar decompression. Study design: Prospective, multi-center, randomized controlled clinical trial. Setting: Twenty-six US interventional pain management centers. Objective: To compare patient outcomes following treatment with either MILD (treatment group) or ESIs (active control group) in LSS patients with neurogenic claudication and verified ligamentum flavum hypertrophy. Methods: This prospective, multi-center, randomized controlled clinical trial includes 2 study arms with a 1-to-1 randomization ratio. A total of 302 patients were enrolled, with 149 randomized to MILD and 153 to the active control. Six-month follow-up has been completed and is presented in this report. In addition, one year follow-up will be conducted for patients in both study arms, and supplementary 2 year outcome data will be collected for patients in the MILD group only. Outcome measures: Outcomes are assessed using the Oswestry Disability Index (ODI), numeric pain rating scale (NPRS) and Zurich Claudication Questionnaire (ZCQ). Primary efficacy is the proportion of ODI responders, tested for statistical superiority of the MILD group versus the active control group. ODI responders are defined as patients achieving the validated Minimal Important Change (MIC) of =10 point improvement in ODI from baseline to follow-up. Similarly, secondary efficacy includes proportion of NPRS and ZCQ responders using validated MIC thresholds. Primary safety is the incidence of device or procedure-related adverse events in each group. Results: At 6 months, all primary and secondary efficacy results provided statistically significant evidence that MILD is superior to the active control. For primary efficacy, the proportion of ODI responders in the MILD group (62.2%) was statistically significantly higher than for the epidural steroid group (35.7%) (P < 0.001). Further, all secondary efficacy parameters demonstrated statistical superiority of MILD versus the active control. The primary safety endpoint was achieved, demonstrating that there is no difference in safety between MILD and ESIs (P = 1.00). Limitations: Limitations include lack of patient blinding due to considerable differences in treatment protocols, and a potentially higher non-responder rate for both groups versus standard-of-care due to study restrictions on adjunctive pain therapies. Conclusions: Six month follow-up data from this trial demonstrate that the MILD procedure is statistically superior to epidural steroids, a known active treatment for LSS patients with neurogenic claudication and verified central stenosis due to ligamentum flavum hypertrophy. The results of all primary and secondary efficacy outcome measures achieved statistically superior outcomes in the MILD group versus ESIs. Further, there were no statistically significant differences in the safety profile between study groups. This prospective, multi-center, randomized controlled clinical trial provides strong evidence of the effectiveness of MILD versus epidural steroids in this patient population. Clinical trial registration: NCT02093520.
    Full-text · Article · Jan 2016 · Pain physician
  • Source
    • "Therefore, the clinicians should not wait too long to observe all the three features of the syndrome. In other patients with signs and symptoms of LSS, a three-month trial of aggressive conservative treatment is usually recommended, but after this time period, surgery has been found to be associated with significant improvement in all primary outcomes [14]. In ordinary LSS, radicular complaints (other than CES) are usually relative surgical indications, even though most of the authors recommend early neural decompression when the radicular pain is present even at rest [15,16]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Lumbar spinal stenosis (LSS) is mostly caused by osteoarthritis (spondylosis). Clinically, the symptoms of patients with LSS can be categorized into two groups; regional (low back pain, stiffness, and so on) or radicular (spinal stenosis mainly presenting as neurogenic claudication). Both of these symptoms usually improve with appropriate conservative treatment, but in refractory cases, surgical intervention is occasionally indicated. In the patients who primarily complain of radiculopathy with an underlying biomechanically stable spine, a decompression surgery alone using a less invasive technique may be sufficient. Preoperatively, with the presence of indicators such as failed back surgery syndrome (revision surgery), degenerative instability, considerable essential deformity, symptomatic spondylolysis, refractory degenerative disc disease, and adjacent segment disease, lumbar fusion is probably recommended. Intraoperatively, in cases with extensive decompression associated with a wide disc space or insufficient bone stock, fusion is preferred. Instrumentation improves the fusion rate, but it is not necessarily associated with improved recovery rate and better functional outcome.
    Full-text · Article · Aug 2014 · Asian spine journal
  • Source
    • "This leads to neurogenic, claudiogenic pain and sometimes low back pain (LBP). The benefits of surgery for this condition is well documented, both in non-randomized and randomized studies [2,3,4,5]. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Retrospective study. The main purpose of this study was to investigate the union-rate of the spinous process after performing a spinous process osteotomy and whether union affects the clinical results after surgery. In the present study, spinous process osteotomy was used to facilitate access to the spinal canal when performing a decompressive procedure for lumbar spinal stenosis. The aim of this study was to evaluate the union rate of the spinous process and its effect on the clinical results of the procedure. All patients were included in the study that underwent a decompressive procedure through spinous process osteotomy be between January 1, 2007 and December 31, 2007. Operation protocols were reviewed. A computed tomography (CT) scan was performed to evaluate the union of the osteotomies of the spinous process. According to the CT-scans, patients were divided into three groups: "complete-union," "partial-union," and "non-union." Patients reported their clinical results through a self-administered questionnaire. The mean period of follow up was 21.6 months (range, 16-28 months). A total of 44% of the performed osteotomies were considered as united. Ten patients (18%) were classified as "complete-union," 30 patients (55%) as "partial-union," and 15 patients (27%) as "non-union." The "complete-union" group showed better clinical results and scored significantly better in the Oswestry Disability Index and EQ-5D. However, no statistical difference was found in the pain-scores. There were no differences between the "partial-union" group and the "no-union" group. We found a radiologic union for 60 out of 135 (44%) spinous process osteotomies.
    Full-text · Article · Apr 2014 · Asian spine journal
Show more