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

BackgroundLumbar 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.MethodsWe 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.DiscussionThis 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.Trial RegistrationClinicaltrials.gov NCT01238536

Preoperative epidural spinal injections increase the risk of surgical wound complications but do not affect overall complication risk or patient-perceived outcomes

“…1 Despite the debate, the use of injections appears to have increased due to the ubiquitous nature of spinal conditions in the general population and the belief that an injection is a relatively safe method of treating persistent or debilitating spinal pain. 2,[8][9][10]13,18 Certainly, patients' desire to exhaust conservative treatments prior to undergoing surgical intervention likely contributes to the increasing rate of injections.…”

Patient Priority Weighting of the Roland Morris Disability Questionnaire Does Not Change Results of the Lumbar Epidural Steroid Injections for Spinal Stenosis Trial

“…2,5 In brief, LESS is a multicenter randomized clinical trial of 400 patients with symptoms related to lumbar central canal stenosis. Patients were randomized to receive either a fluoroscopically guided epidural injection with corticosteroid + lidocaine or an epidural injection with lidocaine alone.…”

“…2-4 Non-operative treatments are commonly attempted for management of spinal stenosis symptoms; however, many questions remain unanswered regarding both short- and long-term outcomes associated with these treatments. 5 …”

Pain Assessment and Management Strategies for Elderly Patients

“…When conservative treatments for the management of spinal stenosis such as nonsteroidal anti-inflammatory drugs (used cautiously in elderly due to risk of bleeding), activity modifications, and physical therapy are not effective, interventional approaches in the management of back pain may be an alternative. The use of minimally invasive procedures, such as epidural steroid injections (ESI), can provide a safe alternative for pain relief when there are substantial risks to the patient with surgical intervention (Friedly et al, 2012).…”