title: Long-Term Effects of Repeated Injections of Local Anesthetic With or Without Corticosteroid for Lumbar Spinal Stenosis: A Randomized Trial.
abstract: To determine the overall long-term effectiveness of treatment with epidural corticosteroid injections for lumbar central spinal stenosis and the effect of repeat injections, including crossover injections, on outcomes through 12 months.
  
  
  
  Multicenter, double-blind, randomized controlled trial comparing epidural injections of corticosteroid plus lidocaine versus lidocaine alone.
  
  
  
  Sixteen clinical sites.
  
  
  
  Participants with imaging-confirmed lumbar central spinal stenosis (N=400).
  
  
  
  Participants were randomized to receive either epidural injections with corticosteroid plus lidocaine or lidocaine alone with the option of blinded crossover after 6 weeks to receive the alternate treatment. Participants could receive 1 to 2 injections from 0 to 6 weeks and up to 2 injections from 6 to 12 weeks. After 12 weeks, participants received usual care.
  
  
  
  Primary outcomes were the Roland-Morris Disability Questionnaire (RDQ) (range, 0-24, where higher scores indicate greater disability) and leg pain intensity (range, 0 [no pain] to 10 [pain as bad as you can imagine]). Secondary outcomes included opioid use, spine surgery, and crossover rates.
  
  
  
  At 12 months, both treatment groups maintained initial observed improvements, with no significant differences between groups on the RDQ (adjusted mean difference, -0.4; 95% confidence interval [CI], -1.6 to 0.9; P=.55), leg pain (adjusted mean difference, 0.1; 95% CI, -0.5 to 0.7; P=.75), opioid use (corticosteroid plus lidocaine: 41.4% vs lidocaine alone: 36.3%; P=.41), or spine surgery (corticosteroid plus lidocaine: 16.8% vs lidocaine alone: 11.8%; P=.22). Fewer participants randomized to corticosteroid plus lidocaine (30%, n=60) versus lidocaine alone (45%, n=90) crossed over after 6 weeks (P=.003). Among participants who crossed over at 6 weeks, the 6- to 12-week RDQ change did not differ between the 2 randomized treatment groups (adjusted mean difference, -1.0; 95% CI, -2.6 to 0.7; P=.24). In both groups, participants crossing over at 6 weeks had worse 12-month trajectories compared with participants who did not choose to crossover.
  
  
  
  For lumbar spinal stenosis symptoms, epidural injections of corticosteroid plus lidocaine offered no benefits from 6 weeks to 12 months beyond that of injections of lidocaine alone in terms of self-reported pain and function or reduction in use of opioids and spine surgery. In patients with improved pain and function 6 weeks after initial injection, these outcomes were maintained at 12 months. However, the trajectories of pain and function outcomes after 3 weeks did not differ by injectate type. Repeated injections of either type offered no additional long-term benefit if injections in the first 6 weeks did not improve pain.
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Rehabilitation Medicine, University of Washington, Seattle, WA. Electronic address: friedlyj@uw.edu.
authors.forename: Janna L
authors.initials: JL
authors.lastname: Friedly
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Biostatistics, University of Washington, Seattle, WA.
authors.forename: Bryan A
authors.initials: BA
authors.lastname: Comstock
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Rehabilitation Medicine, University of Washington, Seattle, WA; Department of Psychiatry & Behavioral Sciences, University of Washington, Seattle, WA.
authors.forename: Judith A
authors.initials: JA
authors.lastname: Turner
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Biostatistics, University of Washington, Seattle, WA.
authors.forename: Patrick J
authors.initials: PJ
authors.lastname: Heagerty
authors.affiliation: Departments of Family Medicine and Internal Medicine, Oregon Health and Science University, Portland, OR; Department of Public Health and Preventive Medicine, Oregon Health and Science University, Portland, OR; Center for Research in Occupational and Environmental Toxicology, Oregon Health and Science University, Portland, OR; Kaiser Permanente Center for Health Research, Portland, OR.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Deyo
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Radiology, University of Washington, Seattle, WA.
authors.forename: Zoya
authors.initials: Z
authors.lastname: Bauer
authors.affiliation: Division of Research, Kaiser Permanente Northern California, Oakland, CA.
authors.forename: Andrew L
authors.initials: AL
authors.lastname: Avins
authors.affiliation: Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital and Spine Unit, Harvard Vanguard Medical Associates, Boston, MA.
authors.forename: Srdjan S
authors.initials: SS
authors.lastname: Nedeljkovic
authors.affiliation: Neuroscience Institute, Henry Ford Hospital, Detroit, MI.
authors.forename: David R
authors.initials: DR
authors.lastname: Nerenz
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Biostatistics, University of Washington, Seattle, WA.
authors.forename: Xu Rita
authors.initials: XR
authors.lastname: Shi
authors.affiliation: Physical Medicine and Rehabilitation Service, VA North Texas Health Care System, Department of Physical Medicine and Rehabilitation, UT Southwestern Medical Center, Dallas, TX.
authors.forename: Thiru
authors.initials: T
authors.lastname: Annaswamy
authors.affiliation: Department of Rehabilitation Medicine, University of Washington, Seattle, WA.
authors.forename: Christopher J
authors.initials: CJ
authors.lastname: Standaert
authors.affiliation: Department of Physical Medicine and Rehabilitation, Stanford University Medical Center, Redwood City, CA.
authors.forename: Matthew
authors.initials: M
authors.lastname: Smuck
authors.affiliation: Department of Physical Medicine and Rehabilitation, Stanford University Medical Center, Redwood City, CA.
authors.forename: David J
authors.initials: DJ
authors.lastname: Kennedy
authors.affiliation: Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO.
authors.forename: Venu
authors.initials: V
authors.lastname: Akuthota
authors.affiliation: Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, Portland, OR.
authors.forename: David
authors.initials: D
authors.lastname: Sibell
authors.affiliation: Department of Anesthesiology and Psychiatry, University of Pittsburgh, Pittsburgh, PA.
authors.forename: Ajay D
authors.initials: AD
authors.lastname: Wasan
authors.affiliation: Department of Radiology, Mayo Clinic, Rochester, MN.
authors.forename: Felix
authors.initials: F
authors.lastname: Diehn
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Rehabilitation Medicine, University of Washington, Seattle, WA; VA Puget Sound Health Care System, Seattle, WA.
authors.forename: Pradeep
authors.initials: P
authors.lastname: Suri
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Rehabilitation Medicine, University of Washington, Seattle, WA.
authors.forename: Sean D
authors.initials: SD
authors.lastname: Rundell
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Health Services, University of Washington, Seattle, WA.
authors.forename: Larry
authors.initials: L
authors.lastname: Kessler
authors.affiliation: Department of Rehabilitation and Regenerative Medicine, Columbia University Medical Center, New York, NY.
authors.forename: Allen S
authors.initials: AS
authors.lastname: Chen
authors.affiliation: Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Radiology, University of Washington, Seattle, WA; Department of Health Services, University of Washington, Seattle, WA.
authors.forename: Jeffrey G
authors.initials: JG
authors.lastname: Jarvik
mesh_terms: D000305:Adrenal Cortex Hormones / Q000008:administration & dosage / Q000627:therapeutic use*; D000779:Anesthetics, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D006801:Humans; D007268:Injections, Epidural; D008012:Lidocaine / Q000627:therapeutic use*; D008159:Lumbar Vertebrae; D059408:Pain Management / Q000379:methods; D013130:Spinal Stenosis / Q000188:drug therapy*; D013997:Time Factors
chemical_list: D000305:Adrenal Cortex Hormones; D000779:Anesthetics, Local; D008012:Lidocaine
keywords: Back pain; Injections, epidural; Rehabilitation; Spinal stenosis