We randomised a total of 94 patients with long-standing moderate lumbar spinal stenosis (LSS) into a surgical group and a non-operative group, with 50 and 44 patients, respectively. The operative treatment comprised undercutting laminectomy of stenotic segments, augmented with transpedicular-instrumented fusion in suspected lumbar instability. The primary outcome was the Oswestry disability index (ODI), and the other main outcomes included assessments of leg and back pain and self-reported walking ability, all based on questionnaire data from 85 patients at the 6-year follow-up. At the 6-year follow-up, the mean difference in ODI in favour of surgery was 9.5 (95% confidence interval 0.9-18.1, P-value for global difference 0.006), whereas the intensity of leg or back pain did not differ between the two treatment groups any longer. Walking ability did not differ between the treatment groups at any time. Decompressive surgery of LSS provided modest but consistent improvement in functional ability, surpassing that obtained after non-operative measures.
OBJECTIVE: To assess the effectiveness of therapeutic exercises alone and in combination with a single physical agent - ultrasound - in patients with lumbar spinal stenosis. DESIGN: Randomized, prospective, controlled trial. SETTING: Department of Physical Medicine and Rehabilitation, University Hospital. SUBJECTS: Forty-five patients presenting with symptoms of neurological claudication and magnetic resonance image-proven lumbar spinal stenosis were assigned to one of three groups: ultrasound plus exercise group (group 1, n =15), sham ultrasound plus exercise group (group 2, n= 15) and no exercise - no treatment group (control group, n = 15). INTERVENTIONS: Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1 mHz, 1.5 W/cm(2) intensity, in continuous mode on the back muscle for 10 minutes in group 1 while ultrasound on/off mode was applied in group 2. MAIN OUTCOME MEASURES: Before and after a three-week period, all subjects were evaluated by pain, disability, functional capacity and consumption of analgesic. RESULTS: Thirty-two of the participants were women and 13 were men, with an average age of 53.2 +/- 12.68 years (range 25-82 years). After a three-week treatment period, leg pain decreased in group 1 (-1.47 +/- 3.02) and group 2 (-2.47 +/- 3.75) compared with the control group (P<0.05). Disability score decreased in group 1 (-3.94 +/- 7.20) and group 2 (-7.80 +/- 10.26) compared with control group (P<0.05). We did not find any statistically significant difference between groups 1 and 2 (P>0.05). The amount of analgesic consumption is significantly less in the group with ultrasound application compared to that in the control group (P<0.05). CONCLUSION: The results of our study suggest that therapeutic exercises are effective for pain and disability in patients with lumbar spinal stenosis and that addition of ultrasound to exercise therapy lowers the analgesic intake substantially.
BACKGROUND: Surgery for spinal stenosis is widely performed, but its effectiveness as compared with nonsurgical treatment has not been shown in controlled trials.
METHODS: 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.
RESULTS: 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.
CONCLUSIONS: 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].).
STUDY DESIGN: A randomized controlled trial.
OBJECTIVES: To assess the effectiveness of decompressive surgery as compared with nonoperative measures in the treatment of patients with lumbar spinal stenosis.
SUMMARY OF BACKGROUND DATA: No previous randomized trial has assessed the effectiveness of surgery in comparison with conservative treatment for spinal stenosis.
METHODS: Four university hospitals agreed on the classification of the disease, inclusion and exclusion criteria, radiographic routines, surgical principles, nonoperative treatment options, and follow-up protocols. A total of 94 patients were randomized into a surgical or nonoperative treatment group: 50 and 44 patients, respectively. Surgery comprised undercutting laminectomy of the stenotic segments in 10 patients augmented with transpedicular fusion. The primary outcome was based on assessment of functional disability using the Oswestry Disability Index (scale, 0-100). Data on the intensity of leg and back pain (scales, 0-10), as well as self-reported and measured walking ability were compiled at randomization and at follow-up examinations at 6, 12, and 24 months.
RESULTS: 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], 4.3-18.4), 1.7 in leg pain (95% CI, 0.4-3.0), and 2.3(95% CI, 1.1-3.6) in back pain. At the 2-year follow-up, the mean differences were slightly less: 7.8 in disability (95% CI, 0.8-14.9) 1.5 in leg pain (95% CI, 0.3-2.8), and 2.1 in back pain (95% CI, 1.0-3.3). Walking ability, either reported or measured, did not differ between the two treatment groups.
CONCLUSIONS: Although patients improved over the 2-year follow-up regardless of initial treatment, those undergoing decompressive surgery reported greater improvement regarding leg pain, back pain, and overall disability. The relative benefit of initial surgical treatment diminished over time, but outcomes of surgery remained favorable at 2 years. Longer follow-up is needed to determine if these differences persist.
STUDY DESIGN: Randomized controlled study.
OBJECTIVES: To investigate the efficacy of treatment with gabapentin on the clinical symptoms and findings in patients with lumbar spinal stenosis (LSS).
SUMMARY OF BACKGROUND DATA: LSS is a syndrome resulting from the narrowing of the lumbar nerve root canal, spinal canal, and intervertebral foramen, causing compression of the spinal cord. The most significant clinical symptom in patients with LSS is neurologic intermittent claudication (NIC). Gabapentin, which has been used in the treatment of neuropathic pain, may be effective in the treatment of symptoms associated with LSS.
METHODS: Fifty-five patients with LSS, who had NIC as the primary complaint, were randomized into 2 groups. All patients were treated with therapeutic exercises, lumbosacral corset with steel bracing, and nonsteroidal anti-inflammatory drugs. The treatment group received gabapentin orally in addition to the standard treatment.
RESULTS: Gabapentin treatment resulted in an increase in the walking distance better than what was obtained with standard treatment (P = 0.001). Gabapentin-treated patients also showed improvements in pain scores (P = 0.006) and recovery of sensory deficit (P = 0.04), better than could be attained with the standard treatment.
CONCLUSION: Based on the results of our pilot study, extensive clinical studies are warranted to investigate the role of gabapentin in the management of symptomatic LSS.
We randomised a total of 94 patients with long-standing moderate lumbar spinal stenosis (LSS) into a surgical group and a non-operative group, with 50 and 44 patients, respectively. The operative treatment comprised undercutting laminectomy of stenotic segments, augmented with transpedicular-instrumented fusion in suspected lumbar instability. The primary outcome was the Oswestry disability index (ODI), and the other main outcomes included assessments of leg and back pain and self-reported walking ability, all based on questionnaire data from 85 patients at the 6-year follow-up. At the 6-year follow-up, the mean difference in ODI in favour of surgery was 9.5 (95% confidence interval 0.9-18.1, P-value for global difference 0.006), whereas the intensity of leg or back pain did not differ between the two treatment groups any longer. Walking ability did not differ between the treatment groups at any time. Decompressive surgery of LSS provided modest but consistent improvement in functional ability, surpassing that obtained after non-operative measures.
