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Lumbar Spinal Surgery Versus Conservative Treatment
Abstract & Commentary
By Michael Rubin, MD, Professor of Clinical Neurology, NewYork-Presbyterian Hospital, Weill Cornell Medical Center. Dr. Rubin is on the speaker's bureau for Athena Diagnostics, and does research for Pfizer and Merck.
Synopsis: Surgery for a herniated lumbar disc with sciatica does not have a better long-term result than conservative therapy. However, surgical decompression for spondylolisthesis with symptomatic spinal stenosis results in better pain relief and functionality, than does conservative treatment.
Sources: Peul WC, et al. Surgery versus prolonged conservative treatment for sciatica. N Engl J Med 2007;356;2245-2256.Weinstein JN, et al. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. ibid 2257-2270.Deyo RA. Back surgery—who needs it? Editorial. ibid 2239-2243.
Two articles, one Dutch and one American, recently reported in the New England Journal of Medicine, provide further support to a growing body of literature that supports the notion that lumbar spine surgery should be undertaken for indications that are more limited than what is currently practiced in the United States.
In the Dutch paper by Peul et al, a prospective, 9-center, randomized study of early surgery vs. conservative treatment was undertaken to determine which strategy provided the better outcome for severe sciatica. Criteria for inclusion required radiologic confirmation of disc herniation in patients 18-65 years old, with incapacitating sciatica of 6-12 weeks duration, diagnosed by a neurologist. Exclusionary criteria included cauda equina syndrome, inability to counter gravity in any muscle tested, prior spine surgery, bony stenosis, spondylolisthesis, pregnancy, or other severe complicating disease. Surgery within 2 weeks of enrollment defined early surgery and comprised a minimal unilateral transflaval approach with nerve root decompression, annular fenestration, curettage, and removal of loose disc material, without performing subtotal discectomy. Patients randomized to conservative management were treated by their family physician, with pain medication as needed, and formal physical therapy if patients were fearful of mobilizing on their own. Surgery was offered if sciatica persisted for another 6 months, and earlier if pain increased or neurologic deficits developed. Primary outcome measures were the Roland (100 point) Disability Questionnaire for Sciatica, the Likert (7 point) self-rating scale for global recovery, and intensity of leg pain during 7 visits over the next 52 weeks. Secondary outcome measures included the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) scale, the Sciatica Frequency and Bothersome Index, and a 100-mm visual analog scale for health perception. Students t-test, Kaplan-Meier survival analysis, and Cox modeling were used for statistical analysis.
Among 283 patients who met inclusion criteria, 141 were randomly assigned to early surgery, but 16 improved before surgery was performed, leaving the remaining 89% to undergo surgery within a mean of 1.9 weeks. Among 142 patients initially assigned to conservative management, 55 (39%) underwent surgery after a mean of 18.7 weeks due to intractable pain. 3.2% of early surgery patients required repeat operations due to recurrence of pain. Pain relief and perceived recovery were faster in the surgery cohort (P < 0.001) but probability of perceived recovery at 1 year was 95% in both groups.
Management of lumbar spinal stenosis due to degenerative spondylolisthesis was the subject of the American paper, authored by Weinstein, et al. 607 patients with neurogenic claudication or radicular leg pain of at least 12 weeks duration, with radiographic evidence of spondylolisthesis on lateral lumbar X-rays and spinal stenosis on cross sectional imaging, were offered enrollment into a randomized (n = 304) or observational (n = 303) cohort, comparing standard nonsurgical care to decompressive laminectomy, with or without bilateral single level fusion with or without posterior pedicle-screw instrumentation. Multiple levels of stenosis was an exclusionary criteria but spondylolysis and isthmic spondylolisthesis were not. Primary outcome measures included the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36) scale and the Oswestry Disability Index at 3, 6, 12, and 24 months following enrollment, whereas secondary outcome measures included the Stenosis Bothersome index, the Low Back Pain Bothersome scale, and patient-reported improvement and satisfaction with current status.
Among 304 randomized patients, 159 were assigned to surgery, of which 64% underwent operation by 2 years. Of 145 patients assigned to the nonsurgery treatment group, 49% had surgery by 2 years. Among 303 patients in the observational group, 173 chose surgery and 97% underwent the operation within 1 year. 130 chose nonsurgical treatment but by 2 years, 25% had surgery. Intention-to-treat analysis revealed no significant difference within the randomized cohort for primary outcome measures. As-treated analysis for both cohorts demonstrated a significant benefit from surgery, in both function and disability index, at 3 months, which increased, and then slightly decreased, at 1 and 2 years, respectively. Surgery, more so than conservative measures, provides significant pain relief and improved functionality for spinal stenosis due to degenerative spondylolisthesis.
Low back pain is big business in the United States. It is the second leading cause of physician visits, the third leading cause for surgical procedures, and the fifth leading cause of hospitalizations, amounting to $24 billion annually in direct medical costs alone. It is crucial to know which patients truly benefit from surgical therapy. As emphasized in the accompanying editorial by Deyo, surgery appears beneficial for degenerative spondylolisthesis resulting in spinal stenosis, a condition predominantly of the elderly, but this benefit must be weighed against the increased risk of complications seen in this age group. Disc herniation, present in up to 40% of asymptomatic young adults (mean age 35 years), when accompanied by sciatica, responds to conservative management if the patient is not in intractable pain and can tolerate the time it takes to recover. Of note, even when surgery in the disc herniation group was delayed for months, the ultimate outcome was no different in the surgical vs. conservatively treated group. Surgery remains an important option in the choice of interventions for low back pain, but its indications and documented benefits are slowly being whittled away.