A study 1 on the effectiveness of surgery for spinal stenosis as compared with nonsurgical treatment enrolled a total of 289 patients in a randomized cohort and 365 patients in an observational cohort at 13 U.S. spine clinics. The mean age of study population was 65 years. For most patients, the overall stenosis was graded as severe. Surgical candidates had spinal stenosis without spondylolisthesis as confirmed on imaging and a history of at least 12 weeks of symptoms. Treatment was decompressive surgery or usual nonsurgical care. At 2 years, 67% of patients who were randomized to surgery had undergone surgery, whereas 43% of those who were assigned to 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 (mean difference in change from baseline of 7.8, 95% confidence interval 1.5 to 14.1). 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 a randomized controlled trial 2, a total of 94 patients with lumbar spinal stenosis were randomized into a surgical (n=50) or nonoperative (n=44) treatment group. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. Both treatment groups showed improvement during follow-up. At 1 year, the mean difference in favor of surgery was 11.3 in disability (95% confidence interval [CI] 4.3 to 18.4), 1.7 in leg pain (95% CI 0.4 to 3.0), and 2.3 (95% CI 1.1 to 3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI 0.8 to 14.9) 1.5 in leg pain (95% CI 0.3 to 2.8), and 2.1 in back pain (95% CI 1.0 to 3.3). Walking ability, either reported or measured, did not differ between the two treatment groups.
A prospective observational cohort study 3 on the long-term outcomes of patients with lumbar spinal stenosis treated surgically or nonsurgically initially enrolled 148 eligible patients. 105 were alive after 10 years. Among surviving patients, long-term follow-up between 8 and 10 years was available for 97 of 123 (79%) patients: 56/63 (89%) initially treated surgically and 41/60 (68%) initially treated nonsurgically. Most patients initially undergoing surgery had a laminectomy without fusion performed. Patients undergoing surgery had worse baseline symptoms and functional status than those initially treated nonsurgically. Outcomes at 1 and 4 years favored initial surgical treatment. After 8 to 10 years, a similar percentage of surgical and nonsurgical patients reported that their low back pain was improved (53% vs. 50%, P = 0.8), their predominant symptom (either back or leg pain) was improved (54% vs. 42%, P = 0.3), and they were satisfied with their current status (55% vs. 49%, P = 0.5). However, patients initially treated surgically reported less severe leg pain symptoms and greater improvement in back-specific functional status after 8 to 10 years than nonsurgically treated patients. By 10 years, 23% of surgical patients had undergone at least one additional lumbar spine operation, and 39% of nonsurgical patients had at least one lumbar spine operation. Outcomes according to actual treatment received at 10 years did not differ because individuals undergoing additional surgical procedures had worse outcomes than those continuing with their initial treatment.
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