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The Appropriate Use of Neurostimulation of the Spinal Cord

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The Appropriate Use of Neurostimulation of the Spinal Cord Neuromodulation: Technology at the Neural Interface Received: September 11, 2013 Revised: January 7, 2014 Accepted: February 28, 2014 (onlinelibrary.wiley.com) DOI: 10.1111/ner.12208 The Appropriate Use of Neurostimulation of the Spinal Cord and Peripheral Nervous System for the Treatment of Chronic Pain and Ischemic Diseases: The Neuromodulation Appropriateness Consensus Committee Timothy R. Deer, MD1; Nagy Mekhail, MD, PhD2; David Provenzano, MD3; Jason Pope, MD1; Elliot Krames, MD4; Michael Leong, MD5; Robert M. Levy, MD, PhD6; David Abejon, MD7; Eric Buchser, MD8,9; Allen Burton, MD10; Asokumar Buvanendran, MD11; Kenneth Candido, MD12; David Caraway, MD, PhD13; Michael Cousins, MD14; Michael DeJongste, MD15; Sudhir Diwan, MD16; Sam Eldabe, MD17; Kliment Gatzinsky, MD, PhD18; Robert D. Foreman, PhD19; Salim Hayek, MD, PhD20,21; Philip Kim, MD22,23; Thomas Kinfe, MD24; David Kloth, MD25; Krishna Kumar, MD26; Syed Rizvi, MD26; Shivanand P. Lad, MD, PhD27; Liong Liem, MD28; Bengt Linderoth, MD, PhD29; Sean Mackey, MD, PhD30; Gladstone McDowell, MD31; Porter McRoberts, MD32; Lawrence Poree, MD, PhD33; Joshua Prager, MD, MS34; Lou Raso, MD35; Richard Rauck, MD36; Marc Russo, MD37; Brian Simpson, MD38; Konstantin Slavin, MD39; Peter Staats, MD40,41; Michael Stanton-Hicks, MD42; Paul Verrills, MD43; Joshua Wellington, MD, MS44; Kayode Williams, MD, MBA41; Richard North, MD41,45* Address correspondence to: Timothy Deer, MD, Center for Pain Relief, 400 Court St, Ste 100, Charleston, WV 25301, USA. Email: [email protected] 25 Department of Anesthesiology, Danbury Hospital, Danbury, CT, USA; 26 Regina General Hospital, University of Saskatchewan, Regina, SK, Canada; 1 Center for Pain Relief, Charleston, WV, USA 27 Division of Neurosurgery, Duke University Medical Center, Durham, NC, USA; 2 Cleveland Clinic, Cleveland, OH, USA; 28 St. Antonius Hospital, Nieuwegein, The Netherlands; 3 Institute for Pain Diagnostics and Care, Ohio Valley General Hospital, Pittsburgh, 29 Functional Neurosurgery and Applied Neuroscience Research Unit, Karolinska PA, USA; Institutet & Karolinska University Hospital, Stockholm, Sweden; 4 Pacific Pain Treatment Center, San Francisco, CA, USA; 30 Division of Pain Medicine, Stanford University, Palo Alto, CA, USA; 5 Stanford University, Palo Alto, CA, USA; 31 Integrated Pain Solutions, Columbus, OH, USA; 6 University of Florida College of Medicine, Jacksonville, FL, USA; 32 Holy Cross Hospital, Fort Lauderdale, FL, USA; 7 Hospital Universitario Quiron, Madrid, Spain; 33 Pain Clinic of Monterey Bay, University of California at San Francisco, San Fran- 8 Anaesthesia and Pain Management Department, EHC Hospital, Morges, cisco, CA, USA; Switzerland; 34 University of California—Los Angeles, Los Angeles, CA, USA; 9 CHUV University Hospital, Lausanne, Switzerland; 35 Jupiter Interventional Pain Management Corp., Jupiter, FL, USA; 10 Houston Pain Associates, Houston, TX, USA; 36 Carolina Pain Institute, Wake Forest Baptist Health, Winston-Salem, NC, USA; 11 Department of Anesthesia, Rush University Medical Center, Chicago, IL, USA; 37 Hunter Pain Clinic, Newcastle, NSW, Australia; 12 University of Illinois College of Medicine, Illinois Masonic Medical Center, 38 Department of Neurosurgery, University Hospital of Wales, Cardiff, UK; Chicago, IL, USA; 39 University of Illinois at Chicago, Chicago, IL, USA; 13 Center for Pain Relief, Tri-State, PLLC, Huntington, WV, USA; 40 Premier Pain Management Centers, Shrewsbury, NJ, USA; 14 University of Sydney at the Royal North Shore Hospital Sydney, Sydney, NSW, 41 Department of Anesthesiology and Critical Care Medicine, Johns Hopkins Uni- Australia; versity School of Medicine, Baltimore, MD, USA; 15 University Medical Center Groningen and University of Groningen, Groningen, 42 Department of Pain Management, Cleveland Clinic, Cleveland, OH, USA; The Netherlands; 43 Metro Spinal Clinic, Melbourne, Vic., Australia; 16 Manhattan Spine and Pain Medicine, Lenox Hill Hospital, New York, NY, USA; 44 Indiana University Pain Medicine Center, Indianapolis, IN, USA; and 17 The James Cook University Hospital, Middlesbrough, UK; 45 The Neuromodulation Foundation, Inc., Baltimore, MD, USA 18 Department of Neurosurgery, Sahlgrenska University Hospital, Gothenburg, Sweden; For more information on author guidelines, an explanation of our peer review 19 College of Medicine, University of Oklahoma Health Sciences Center, Okla- process, and conflict of interest informed consent policies, please go to http:// homa City, OK, USA; www.wiley.com/bw/submit.asp?ref=1094-7159&site=1 20 Department of Anesthesiology, Case Western Reserve University, Cleveland, * Retired from Johns Hopkins University School of Medicine. OH, USA; 21 Division of Pain Medicine, University Hospitals Case Medical Center, Cleveland, Sources of financial support: This project was supported by the International OH, USA; Neuromodulation Society and was partially funded by a series of unrestricted 22 Christiana Hospital, Newark, DE, USA; educational grants from Medtronic, Inc., St. Jude Medical, Inc., Boston Scientific 515 23 Bryn Mawr Hospital, Bryn Mawr, PA, USA; Corp., Nevro Corp., and Spinal Modulation, Inc. No corporate entities had any direct 24 Department of Neurosurgery, Heinrich Heine University, Dusseldorf, Germany; input into the contents of this manuscript or the conclusions of the collaborators. www.neuromodulationjournal.com © 2014 International Neuromodulation Society Neuromodulation 2014; 17: 515–550 DEER ET AL. Introduction: The Neuromodulation Appropriateness Consensus Committee (NACC) of the International Neuromodulation Society (INS) evaluated evidence regarding the safety and efficacy of neurostimulation to treat chronic pain, chronic critical limb ischemia, and refractory angina and recommended appropriate clinical applications. Methods: The NACC used literature reviews, expert opinion, clinical experience, and individual research. Authors consulted the Practice Parameters for the Use of Spinal Cord Stimulation in the Treatment of Neuropathic Pain (2006), systematic reviews (1984 to 2013), and prospective and randomized controlled trials (2005 to 2013) identified through PubMed, EMBASE, and Google Scholar. Results: Neurostimulation is relatively safe because of its minimally invasive and reversible characteristics. Comparison with medical management is difficult, as patients considered for neurostimulation have failed conservative management. Unlike alternative therapies, neurostimulation is not associated with medication-related side effects and has enduring effect. Device- related complications are not uncommon; however, the incidence is becoming less frequent as technology progresses and surgical skills improve. Randomized controlled studies support the efficacy of spinal cord stimulation in treating failed back surgery syndrome and complex regional pain syndrome. Similar studies of neurostimulation for peripheral neuropathic pain, postamputation pain, postherpetic neuralgia, and other causes of nerve injury are needed. International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated. Conclusions: Appropriate neurostimulation is safe and effective in some chronic pain conditions. Technological refinements and clinical evidence will continue to expand its use. The NACC seeks to facilitate the efficacy and safety of neurostimulation. Keywords: Angina pectoris, chronic pain, complex regional pain syndrome, failed back surgery syndrome, high-frequency elec- trical stimulation, ischemic pain, neuropathic pain, nociceptive pain, phantom limb pain, postherpetic neuralgia, Reynaud’s syndrome, spinal cord stimulation Conflict of Interest: Dr. Deer holds minor stock options in Bioness, Inc., Spinal Modulation, Inc., and Nevro Corp. He is a paid consultant for St. Jude Medical, Inc., Spinal Modulation, Inc., Bioness, Inc., Nevro Corp., and Medtronic, Inc. He has patent relation- ships with Bioness, Inc. and Nevro Corp. He is an advisor for St. Jude Medical, Inc., Medtronic, Inc., Spinal Modulation, Inc., Bioness, Inc., Nevro Corp., Flowonix Medical, Inc., and Jazz Pharmaceuticals PLC. Dr. Mekhail has no conflicts of interest to report. Dr. Provenzano is a paid consultant for Medtronic, Inc. and St. Jude Medical, Inc. Dr. Pope is a paid consultant for Medtronic, Inc., St. Jude Medical, Inc., and Spinal Modulation, Inc. He is a speaker for Jazz Pharmaceuticals PLC. Dr. Krames holds stock options with Nevro Corp. and Spinal Modulation, Inc. He is a minor stockholder with Medtronic, Inc. Dr. Levy holds stock options with Spinal Modulation, Inc. and Bioness, Inc. He is a paid consultant for St. Jude Medical, Inc., Medtronic, Inc., Spinal Modulation, Inc., Vertos Medical, Inc., Bioness, Inc., and Boston Scientific Corp. Dr. Abejon is a speaker for St. Jude Medical, Inc., Boston Scientific Corp., Medtronic, Inc., Nevro Corp., Cardiva Medical, Inc., and Prim SA. Dr. Buchser is a paid consultant for Medtronic, Switzerland. His employer, EHC Hospital, Morges, Switzerland, has received fees for expert testimony that he provided for Medtronic. He has been reimbursed for travel costs by Medtronic Switzerland. Dr. Burton is a paid consultant for Medtronic, Inc. Dr. Buvanendran consults for Medtronic, Inc. Dr. Candido has no conflicts of interest to report. Dr. Caraway owns stock options in Spinal Modulation, Inc. He has a management/advisory role with Medtronic, Inc., Spinal Modulation, Inc., Nevro Corp., Bioness, Inc., and Jazz Pharmaceuticals PLC. He
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