Study protocol- Lumbar Epidural steroid injections for Spinal Stenosis (LESS): a double-blind randomized controlled trial of epidural steroid injections for lumbar spinal stenosis among older adults.
ABSTRACT Lumbar spinal stenosis is one of the most common causes of low back pain among older adults and can cause significant disability. Despite its prevalence, treatment of spinal stenosis symptoms remains controversial. Epidural steroid injections are used with increasing frequency as a less invasive, potentially safer, and more cost-effective treatment than surgery. However, there is a lack of data to judge the effectiveness and safety of epidural steroid injections for spinal stenosis. We describe our prospective, double-blind, randomized controlled trial that tests the hypothesis that epidural injections with steroids plus local anesthetic are more effective than epidural injections of local anesthetic alone in improving pain and function among older adults with lumbar spinal stenosis.
We will recruit up to 400 patients with lumbar central canal spinal stenosis from at least 9 clinical sites over 2 years. Patients with spinal instability who require surgical fusion, a history of prior lumbar surgery, or prior epidural steroid injection within the past 6 months are excluded. Participants are randomly assigned to receive either ESI with local anesthetic or the control intervention (epidural injections with local anesthetic alone). Subjects receive up to 2 injections prior to the primary endpoint at 6 weeks, at which time they may choose to crossover to the other intervention.Participants complete validated, standardized measures of pain, functional disability, and health-related quality of life at baseline and at 3 weeks, 6 weeks, and 3, 6, and 12 months after randomization. The primary outcomes are Roland-Morris Disability Questionnaire and a numerical rating scale measure of pain intensity at 6 weeks. In order to better understand their safety, we also measure cortisol, HbA1c, fasting blood glucose, weight, and blood pressure at baseline, and at 3 and 6 weeks post-injection. We also obtain data on resource utilization and costs to assess cost-effectiveness of epidural steroid injection.
This study is the first multi-center, double-blind RCT to evaluate the effectiveness of epidural steroid injections in improving pain and function among older adults with lumbar spinal stenosis. The study will also yield data on the safety and cost-effectiveness of this procedure for older adults.
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ABSTRACT: Degenerative lumbar stenosis is a common source of pain and disability in the elderly. It presents clinically with a variety of symptoms, though neurogenic claudication is the hallmark. There is a multifactorial pathogenesis to lumbar stenosis and its symptoms, and thus, there are multiple management approaches available. Epidural steroid injections (ESIs) are a popular choice in management, however, the literature is vague in definitive support of their use, and providers that utilize injections can use variable techniques to access the spinal canal in order to deposit the steroid at the appropriate site. This article will review degenerative lumbar stenosis in general and focus on the use of ESIs to better define their role in this management process. In addition, the evidence to discern the optimal injection route will be presented.Current Reviews in Musculoskeletal Medicine 04/2008; 1(1):32-8.
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ABSTRACT: The management of degenerative spondylolisthesis associated with spinal stenosis remains controversial. Surgery is widely used and has recently been shown to be more effective than nonoperative treatment when the results were followed over two years. Questions remain regarding the long-term effects of surgical treatment compared with those of nonoperative treatment. Surgical candidates from thirteen centers with symptoms of at least twelve weeks' duration as well as confirmatory imaging showing degenerative spondylolisthesis with spinal stenosis were offered enrollment in a randomized cohort or observational cohort. Treatment consisted of standard decompressive laminectomy (with or without fusion) or usual nonoperative care. Primary outcome measures were the Short Form-36 (SF-36) bodily pain and physical function scores and the modified Oswestry Disability Index at six weeks, three months, six months, and yearly up to four years. In the randomized cohort (304 patients enrolled), 66% of those randomized to receive surgery received it by four years whereas 54% of those randomized to receive nonoperative care received surgery by four years. In the observational cohort (303 patients enrolled), 97% of those who chose surgery received it whereas 33% of those who chose nonoperative care eventually received surgery. The intent-to-treat analysis of the randomized cohort, which was limited by nonadherence to the assigned treatment, showed no significant differences in treatment outcomes between the operative and nonoperative groups at three or four years. An as-treated analysis combining the randomized and observational cohorts that adjusted for potential confounders demonstrated that the clinically relevant advantages of surgery that had been previously reported through two years were maintained at four years, with treatment effects of 15.3 (95% confidence interval, 11 to 19.7) for bodily pain, 18.9 (95% confidence interval, 14.8 to 23) for physical function, and -14.3 (95% confidence interval, -17.5 to -11.1) for the Oswestry Disability Index. Early advantages (at two years) of surgical treatment in terms of the secondary measures of bothersomeness of back and leg symptoms, overall satisfaction with current symptoms, and self-rated progress were also maintained at four years. Compared with patients who are treated nonoperatively, patients in whom degenerative spondylolisthesis and associated spinal stenosis are treated surgically maintain substantially greater pain relief and improvement in function for four years.The Journal of Bone and Joint Surgery 07/2009; 91(6):1295-304. · 3.23 Impact Factor
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ABSTRACT: Pedicle screw fixation is frequently used for spinal fusion in elderly patients. The application of pedicle screw fixation for elderly patients with degenerative lumbar disease remains controversial due to problems such as surgical invasion, osteoporosis, and cost performance. Outcomes of spinal fusion using pedicle screw fixation were evaluated in patients older than 70 years with lumbar spinal canal stenosis. Eighty-one patients older than 70 years with degenerative disorders of the lumbar spine were treated with pedicle screw fixation before 1997. They were 70 to 85 years at screw fixation (mean, 74.1 years). The postoperative follow-up period was 3 to 18 years (mean, 8.2 years). The number of fused levels by pedicle screw fixation was 1 to 7 (mean, 2.1), and bone grafting was performed in 19 patients who underwent posterolateral lumbar fusion with posterior lumbar interbody fusion and in 62 (76.5%) who underwent posterolateral lumbar fusion alone. Bone union was radiographically observed in 90.1%. The grade of independence (Independence [Bedridden] Criteria of the Daily Life of the Impaired Elderly) had been rank J (life independence) in all patients 1 year preoperatively, but deteriorated to rank A1 (capable of going out with a helper) in 51.8% of patients and rank B1 (using a wheelchair) in 19.8% immediately preoperatively. The grade of independence was rank J in 85.6% of patients 3 years postoperatively and remained rank J in 40 (87.0%) of the 46 who were alive 10 years postoperatively. Few complications associated with surgical invasion were found, and the grade of independence tended to remain at a high level for 10 years postoperatively.Orthopedics 12/2008; 31(11):1096. · 1.05 Impact Factor