title: 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: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT01238536.
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, USA. friedlyj@uw.edu
authors.forename: Janna L
authors.initials: JL
authors.lastname: Friedly
authors.forename: Brian W
authors.initials: BW
authors.lastname: Bresnahan
authors.forename: Bryan
authors.initials: B
authors.lastname: Comstock
authors.forename: Judith A
authors.initials: JA
authors.lastname: Turner
authors.forename: Richard A
authors.initials: RA
authors.lastname: Deyo
authors.forename: Sean D
authors.initials: SD
authors.lastname: Sullivan
authors.forename: Patrick
authors.initials: P
authors.lastname: Heagerty
authors.forename: Zoya
authors.initials: Z
authors.lastname: Bauer
authors.forename: Srdjan S
authors.initials: SS
authors.lastname: Nedeljkovic
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Avins
authors.forename: David
authors.initials: D
authors.lastname: Nerenz
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Jarvik
mesh_terms: D000367:Age Factors; D000779:Anesthetics, Local / Q000008:administration & dosage; D001416:Back Pain / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000208:ethnology / Q000503:physiopathology; D003362:Cost-Benefit Analysis; D018592:Cross-Over Studies; D004185:Disability Evaluation; D004311:Double-Blind Method; D016527:Drug Costs; D004359:Drug Therapy, Combination; D006801:Humans; D007268:Injections, Epidural; D008159:Lumbar Vertebrae / Q000187:drug effects* / Q000503:physiopathology; D008875:Middle Aged; D010147:Pain Measurement; D011446:Prospective Studies; D020127:Recovery of Function; D012042:Registries; D012107:Research Design; D012720:Severity of Illness Index; D013130:Spinal Stenosis / Q000175:diagnosis / Q000188:drug therapy* / Q000191:economics / Q000208:ethnology / Q000503:physiopathology; D013256:Steroids / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States / Q000453:epidemiology
chemical_list: D000779:Anesthetics, Local; D013256:Steroids