James P Rathmell1, Honorio T Benzon, Paul Dreyfuss, Marc Huntoon, Mark Wallace, Ray Baker, K Daniel Riew, Richard W Rosenquist, Charles Aprill, Natalia S Rost, Asokumar Buvanendran, D Scott Kreiner, Nikolai Bogduk, Daryl R Fourney, Eduardo Fraifeld, Scott Horn, Jeffrey Stone, Kevin Vorenkamp, Gregory Lawler, Jeffrey Summers, David Kloth, David O'Brien, Sean Tutton. 1. From the Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts (J.P.R., N.S.R.); Northwestern University Feinberg School of Medicine, Chicago, Illinois (H.T.B.); EvergreenHealth, Kirkland, Washington (P.D., R.B.); Vanderbilt University School of Medicine, Nashville, Tennessee (M.H.); University of California San Diego, San Diego, California (M.W.); Washington University School of Medicine, St. Louis, Missouri (K.D.R.); Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio (R.W.R.); Interventional Spine Specialists, Kenner, Louisiana (C.A.); Rush Medical College, Chicago, Illinois (A.B.); Ahwatukee Sports and Spine, Phoenix, Arizona (D.S.K.); University of Newcastle, Newcastle, Australia (N.B.); University of Saskatchewan, Saskatoon, Saskatchewan, Canada (D.R.F.); Southside Pain Solutions, Danville, Virginia (E.F.); APM Spine and Sports Physicians, Virginia Beach, Virginia (S.H.); Mayo Clinic Florida, Jacksonville, Florida (J. Stone); Virginia Mason Medical Center, Seattle, Washington (K.V.); Neuroimaging and Interventional Spine Services, LLC, Ridgefield, Connecticut (G.L.); NewSouth NeuroSpine, Flowood, Mississippi (J. Summers); Danbury Hospital, Danbury, Connecticut (D.K.); University of North Carolina School of Medicine, Winston Salem, North Carolina (D.O.); and Medical College of Wisconsin/Froedtert Hospital, Milwaukee, Wisconsin (S.T.).
Abstract
BACKGROUND: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections. METHODS: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process. RESULTS: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration. CONCLUSION: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.
BACKGROUND: Epidural corticosteroid injections are a common treatment for radicular pain caused by intervertebral disc herniations, spinal stenosis, and other disorders. Although rare, catastrophic neurologic injuries, including stroke and spinal cord injury, have occurred with these injections. METHODS: A collaboration was undertaken between the U.S. Food and Drug Administration Safe Use Initiative, an expert multidisciplinary working group, and 13 specialty stakeholder societies. The goal of this collaboration was to review the existing evidence regarding neurologic complications associated with epidural corticosteroid injections and produce consensus procedural clinical considerations aimed at enhancing the safety of these injections. U.S. Food and Drug Administration Safe Use Initiative representatives helped convene and facilitate meetings without actively participating in the deliberations or decision-making process. RESULTS: Seventeen clinical considerations aimed at improving safety were produced by the stakeholder societies. Specific clinical considerations for performing transforaminal and interlaminar injections, including the use of nonparticulate steroid, anatomic considerations, and use of radiographic guidance are given along with the existing scientific evidence for each clinical consideration. CONCLUSION: Adherence to specific recommended practices when performing epidural corticosteroid injections should lead to a reduction in the incidence of neurologic injuries.
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