Janna L Friedly1, Bryan A Comstock2, Judith A Turner3, Patrick J Heagerty2, Richard A Deyo4, Zoya Bauer5, Andrew L Avins6, Srdjan S Nedeljkovic7, David R Nerenz8, Xu Rita Shi2, Thiru Annaswamy9, Christopher J Standaert10, Matthew Smuck11, David J Kennedy11, Venu Akuthota12, David Sibell13, Ajay D Wasan14, Felix Diehn15, Pradeep Suri16, Sean D Rundell17, Larry Kessler18, Allen S Chen19, Jeffrey G Jarvik20. 1. 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. 2. Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Biostatistics, University of Washington, Seattle, WA. 3. 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. 4. 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. 5. Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Radiology, University of Washington, Seattle, WA. 6. Division of Research, Kaiser Permanente Northern California, Oakland, CA. 7. Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital and Spine Unit, Harvard Vanguard Medical Associates, Boston, MA. 8. Neuroscience Institute, Henry Ford Hospital, Detroit, MI. 9. Physical Medicine and Rehabilitation Service, VA North Texas Health Care System, Department of Physical Medicine and Rehabilitation, UT Southwestern Medical Center, Dallas, TX. 10. Department of Rehabilitation Medicine, University of Washington, Seattle, WA. 11. Department of Physical Medicine and Rehabilitation, Stanford University Medical Center, Redwood City, CA. 12. Department of Physical Medicine and Rehabilitation, University of Colorado, Aurora, CO. 13. Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, Portland, OR. 14. Department of Anesthesiology and Psychiatry, University of Pittsburgh, Pittsburgh, PA. 15. Department of Radiology, Mayo Clinic, Rochester, MN. 16. 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. 17. Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Rehabilitation Medicine, University of Washington, Seattle, WA. 18. Comparative Effectiveness, Cost and Outcomes Research Center, University of Washington, Seattle, WA; Department of Health Services, University of Washington, Seattle, WA. 19. Department of Rehabilitation and Regenerative Medicine, Columbia University Medical Center, New York, NY. 20. 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.
Abstract
OBJECTIVE: 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. DESIGN: Multicenter, double-blind, randomized controlled trial comparing epidural injections of corticosteroid plus lidocaine versus lidocaine alone. SETTING: Sixteen clinical sites. PARTICIPANTS: Participants with imaging-confirmed lumbar central spinal stenosis (N=400). INTERVENTIONS: 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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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.
RCT Entities:
OBJECTIVE: 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. DESIGN: Multicenter, double-blind, randomized controlled trial comparing epidural injections of corticosteroid plus lidocaine versus lidocaine alone. SETTING: Sixteen clinical sites. PARTICIPANTS: Participants with imaging-confirmed lumbar central spinal stenosis (N=400). INTERVENTIONS: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. MAIN OUTCOME MEASURES: 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. RESULTS: 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. CONCLUSIONS: 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: Crystian B Oliveira; Christopher G Maher; Manuela L Ferreira; Mark J Hancock; Vinicius Cunha Oliveira; Andrew J McLachlan; Bart W Koes; Paulo H Ferreira; Steven P Cohen; Rafael Zambelli Pinto Journal: Cochrane Database Syst Rev Date: 2020-04-09
Authors: Stephen Schaaf; Wan Huang; Subashan Perera; Yvette Conley; Inna Belfer; Prakash Jayabalan; Katie Tremont; Paulo Coelho; Sara Ernst; Megan Cortazzo; Debra Weiner; Nam Vo; James Kang; Gwendolyn Sowa Journal: Am J Phys Med Rehabil Date: 2021-01-01 Impact factor: 3.412
Authors: Maurizio Fornari; Scott C Robertson; Paulo Pereira; Mehmet Zileli; Carla D Anania; Ana Ferreira; Silvano Ferrari; Roberto Gatti; Francesco Costa Journal: World Neurosurg X Date: 2020-06-23
Authors: Carlo Ammendolia; Corey Hofkirchner; Joshua Plener; André Bussières; Michael J Schneider; James J Young; Andrea D Furlan; Kent Stuber; Aksa Ahmed; Carol Cancelliere; Aleisha Adeboyejo; Joseph Ornelas Journal: BMJ Open Date: 2022-01-19 Impact factor: 2.692