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The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Best Practices for Cervical Neurostimulation

      Abstract

      Introduction

      The International Neuromodulation Society convened a multispecialty group of physicians based on expertise with international representation to establish evidence-based guidance on the use of neurostimulation in the cervical region to improve outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for an often-overlooked area of neurostimulation practice.

      Materials and Methods

      Authors were chosen based upon their clinical expertise, familiarity with the peer-reviewed literature, research productivity, and contributions to the neuromodulation literature. Section leaders supervised literature searches of MEDLINE, BioMed Central, Current Contents Connect, Embase, International Pharmaceutical Abstracts, Web of Science, Google Scholar, and PubMed from 2017 (when NACC last published guidelines) to the present. Identified studies were graded using the US Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on the strength of evidence or consensus when evidence was scant.

      Results

      The NACC examined the published literature and established evidence- and consensus-based recommendations to guide best practices. Additional guidance will occur as new evidence is developed in future iterations of this process.

      Conclusions

      The NACC recommends best practices regarding the use of cervical neuromodulation to improve safety and efficacy. The evidence- and consensus-based recommendations should be utilized as a guide to assist decision making when clinically appropriate.

      Keywords

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      References

        • Nandyala S.V.
        • Marquez-Lara A.
        • Fineberg S.J.
        • Hassanzadeh H.
        • Singh K.
        Complications after lumbar spine surgery between teaching and nonteaching hospitals.
        Spine. 2014; 39: 417-423
        • Marquez-Lara A.
        • Nandyala S.V.
        • Fineberg S.J.
        • Singh K.
        Current trends in demographics, practice, and in-hospital outcomes in cervical spine surgery: a national database analysis between 2002 and 2011.
        Spine. 2014; 39: 476-481
        • Christelis N.
        • Simpson B.
        • Russo M.
        • et al.
        Persistent spinal pain syndrome: a proposal for failed back surgery syndrome and ICD-11.
        Pain Med. 2021; 22: 807-818
        • Provenzano D.A.
        • Amirdelfan K.
        • Kapural L.
        • Sitzman B.T.
        Evidence gaps in the use of spinal cord stimulation for treating chronic spine conditions.
        Spine. 2017; 42: S80-S92
        • Chivukula S.
        • Tomycz N.D.
        • Moossy J.J.
        Paddle lead cervical spinal cord stimulation for failed neck surgery syndrome.
        Clin Neurol Neurosurg. 2013; 115: 2254-2256
        • Taylor R.S.
        • Van Buyten J.P.
        • Buchser E.
        Spinal cord stimulation for complex regional pain syndrome: a systematic review of the clinical and cost-effectiveness literature and assessment of prognostic factors.
        Eur J Pain. 2006; 10: 91-101
        • Rosenberg J.
        • Fabi A.
        • Candido K.
        • et al.
        Spinal cord stimulation provides pain relief with improved psychosocial function: results from EMP3OWER.
        Pain Med. 2016; 17: 2311-2325
        • Deer T.
        • Skaribas I.
        • McJunkin T.
        • et al.
        Results from the partnership for advancement in neuromodulation registry: a 24-month follow-up.
        Neuromodulation. 2016; 19: 179-187
        • Hosobuchi Y.
        Electrical stimulation of the cervical spinal cord increases cerebral blood flow in humans.
        Appl Neurophysiol. 1985; 48: 372-376
        • Swigris J.J.
        • Olin J.W.
        • Mekhail N.A.
        Implantable spinal cord stimulator to treat the ischemic manifestations of thromboangiitis obliterans (Buerger’s disease).
        J Vasc Surg. 1999; 29: 928-935
        • Tomycz N.D.
        • Deibert C.P.
        • Moossy J.J.
        Cervicomedullary junction spinal cord stimulation for head and facial pain.
        Headache. 2011; 51: 418-425
        • Matharu M.S.
        • Bartsch T.
        • Ward N.
        • Frackowiak R.S.
        • Weiner R.
        • Goadsby P.J.
        Central neuromodulation in chronic migraine patients with suboccipital stimulators: a PET study.
        Brain. 2004; 127: 220-230
        • Abdel-Aziz S.
        • Ghaleb A.H.
        Cervical spinal cord stimulation for the management of pain from brachial plexus avulsion.
        Pain Med. 2014; 15: 712-714
        • De Andrés J.
        • Tatay J.
        • Revert A.
        • Valía J.C.
        • Villanueva V.
        The beneficial effect of spinal cord stimulation in a patient with severe cerebral ischemia and upper extremity ischemic pain.
        Pain Pract. 2007; 7: 135-142https://doi.org/10.1111/j.1533-2500.2007.00121.x
        • Deer T.R.
        • Mekhail N.
        • Provenzano D.
        • et al.
        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.
        Neuromodulation. 2014; 17 ([discussion: 550]): 515-550
        • Deer T.R.
        • Lamer T.J.
        • Pope J.E.
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC) safety guidelines for the reduction of severe neurological injury.
        Neuromodulation. 2017; 20: 15-30
        • Deer T.R.
        • Provenzano D.A.
        • Hanes M.
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for infection prevention and management.
        Neuromodulation. 2017; 20: 31-50
        • Deer T.R.
        • Narouze S.
        • Provenzano D.A.
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC): recommendations on bleeding and coagulation management in neurostimulation devices.
        Neuromodulation. 2017; 20: 51-62
        • Deer T.R.
        • Hayek S.M.
        • Pope J.E.
        • et al.
        The Polyanalgesic Consensus Conference (PACC): recommendations for trialing of intrathecal drug delivery infusion therapy.
        Neuromodulation. 2017; 20: 133-154
        • Deer T.R.
        • Pope J.E.
        • Hayek S.M.
        • et al.
        The Polyanalgesic Consensus Conference (PACC): recommendations on intrathecal drug infusion systems best practices and guidelines.
        Neuromodulation. 2017; 20: 96-132
        • Deer T.R.
        • Pope J.E.
        • Hayek S.M.
        • et al.
        The Polyanalgesic Consensus Conference (PACC): recommendations for intrathecal drug delivery: guidance for improving safety and mitigating risks.
        Neuromodulation. 2017; 20: 155-176
        • Harris R.P.
        • Helfand M.
        • Woolf S.H.
        • et al.
        Current methods of the US Preventive Services Task Force: a review of the process.
        Am J Prev Med. 2001; 20: 21-35
        • Deer T.R.
        • Skaribas I.M.
        • Haider N.
        • et al.
        Effectiveness of cervical spinal cord stimulation for the management of chronic pain.
        Neuromodulation. 2014; 17: 265-271
        • Simpson B.A.
        • Bassett G.
        • Davies K.
        • Herbert C.
        • Pierri M.
        Cervical spinal cord stimulation for pain: a report on 41 patients.
        Neuromodulation. 2003; 6: 20-26
        • Whitworth L.A.
        • Feler C.A.
        C1-C2 sublaminar insertion of paddle leads for the management of chronic painful conditions of the upper extremity.
        Neuromodulation. 2003; 6: 153-157
        • Chivukula S.
        • Tempel Z.J.
        • Weiner G.M.
        • et al.
        Cervical and cervicomedullary spinal cord stimulation for chronic pain: efficacy and outcomes.
        Clin Neurol Neurosurg. 2014; 127: 33-41
        • Velásquez C.
        • Tambirajoo K.
        • Franceschini P.
        • Eldridge P.R.
        • Farah J.O.
        Upper cervical spinal cord stimulation as an alternative treatment in trigeminal neuropathy.
        World Neurosurg. 2018; 114: e641-e646
        • Texakalidis P.
        • Tora M.S.
        • Nagarajan P.
        • Keifer O.P.
        • Boulis N.M.
        High cervical spinal cord stimulation for occipital neuralgia: a case series and literature review.
        J Pain Res. 2019; 12: 2547-2553
        • Robaina F.J.
        • Dominguez M.
        • Díaz M.
        • Rodriguez J.L.
        • de Vera J.A.
        Spinal cord stimulation for relief of chronic pain in vasospastic disorders of the upper limbs.
        Neurosurgery. 1989; 24: 63-67
        • Vallejo R.
        • Kramer J.M.
        • Benyamin R.
        Neuromodulation of the cervical spinal cord in the treatment of chronic intractable neck and upper extremity pain: a case series and review of the literature.
        Pain Physician. 2007; 10: 305-311
        • Wolter T.
        • Kiemen A.
        • Kaube H.
        High cervical spinal cord stimulation for chronic cluster headache.
        Cephalalgia. 2011; 31: 1170-1180
        • Al-Kaisy A.
        • Palmisani S.
        • Smith T.
        • Harris S.
        • Pang D.
        The use of 10-kilohertz spinal cord stimulation in a cohort of patients with chronic neuropathic limb pain refractory to medical management.
        Neuromodulation. 2015; 18: 18-23https://doi.org/10.1111/ner.12237
        • De Agostino R.
        • Federspiel B.
        • Cesnulis E.
        • Sandor P.S.
        High-cervical spinal cord stimulation for medically intractable chronic migraine.
        Neuromodulation. 2015; 18: 289-296
        • Lambru G.
        • Trimboli M.
        • Palmisani S.
        • Smith T.
        • Al-Kaisy A.
        Safety and efficacy of cervical 10 kHz spinal cord stimulation in chronic refractory primary headaches: a retrospective case series.
        J Headache Pain. 2016; 17: 66
        • El Majdoub F.
        • Neudorfer C.
        • Richter R.
        • Schieferdecker S.
        • Maarouf M.
        10 kHz cervical SCS for chronic neck and upper limb pain: 12 months’ results.
        Ann Clin Transl Neurol. 2019; 6: 2223-2229
        • Mazzone P.
        • Viselli F.
        • Ferraina S.
        • et al.
        High cervical spinal cord stimulation: a one year follow-up study on motor and non-motor functions in Parkinson’s disease.
        Brain Sci. 2019; 9: 78
        • Sayed D.
        • Salmon J.
        • Khan T.W.
        • et al.
        Retrospective analysis of real-world outcomes of 10 kHz SCS in patients with upper limb and neck pain.
        J Pain Res. 2020; 13: 1441-1448
        • Waltz J.M.
        • Scozzari C.A.
        • Hunt D.P.
        Spinal cord stimulation in the treatment of spasmodic torticollis.
        Appl Neurophysiol. 1985; 48: 324-338
        • Baird T.A.
        • Karas C.S.
        The use of high-dose cervical spinal cord stimulation in the treatment of chronic upper extremity and neck pain.
        Surg Neurol Int. 2020; 10: 1-3
        • Haider S.
        • Owusu-Sarpong S.
        • Peris Celda M.
        • et al.
        A single center prospective observational study of outcomes with tonic cervical spinal cord stimulation.
        Neuromodulation. 2017; 20: 263-268
        • Arcioni R.
        • Palmisani S.
        • Mercieri M.
        • et al.
        Cervical 10 kHz spinal cord stimulation in the management of chronic, medically refractory migraine: a prospective, open-label, exploratory study.
        Eur J Pain. 2016; 20: 70-78
        • Hunter C.W.
        • Carlson J.
        • Yang A.
        • Deer T.
        Spinal cord stimulation for the treatment of failed neck surgery syndrome: outcome of a prospective case series.
        Neuromodulation. 2018; 21: 495-503
        • Verrills P.
        • Salmon J.
        • Russo M.
        • Gliner B.
        • Barnard A.
        • Caraway D.
        10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.
        Eur Spine J. 2020; 29: 2786-2794
        • Grider J.S.
        • Harned M.
        Cervical spinal cord stimulation using monophasic burst waveform for axial neck and upper extremity radicular pain: a preliminary observational study.
        Neuromodulation. 2020; 23: 680-686
        • Amirdelfan K.
        • Vallejo R.
        • Benyamin R.
        • et al.
        High-frequency spinal cord stimulation at 10 kHz for the treatment of combined neck and arm pain: results from a prospective multicenter study.
        Neurosurgery. 2020; 87: 176-185
        • Kumar K.
        • Malik S.
        • Demeria D.
        Treatment of chronic pain with spinal cord stimulation versus alternative therapies: cost-effectiveness analysis.
        Neurosurgery. 2002; 51: 106-115
        • Kapural L.
        • Yu C.
        • Doust M.W.
        • et al.
        Novel 10-kHz high-frequency therapy (HF10 therapy) is superior to traditional low-frequency spinal cord stimulation for the treatment of chronic back and leg pain: the SENZA-RCT randomized controlled trial.
        Anesthesiology. 2015; 123: 851-860
        • North R.B.
        • Recinos V.R.
        • Attenello F.J.
        • Shipley J.
        • Long D.M.
        Prevention of percutaneous spinal cord stimulation electrode migration: a 15-year experience.
        Neuromodulation. 2014; 17: 670-676
      1. US Department of Health and Human Services. Pain management best practices inter-agency task force report: updates, gaps, inconsistencies, and recommendations; May 2019. Accessed May 25, 2021. https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html

        • Kumar K.
        • Rizvi S.
        • Bnurs S.B.
        Spinal cord stimulation is effective in management of complex regional pain syndrome I: fact or fiction.
        Neurosurgery. 2011; 69: 566-578
        • Richardson J.
        • Groen G.J.
        Applied epidural anatomy.
        Contin Educ Anaesth Crit Care Pain. 2005; 5: 98-100https://doi.org/10.1093/bjaceaccp/mki026
        • Hogan Q.
        Distribution of solution in the epidural space: examination by cryomicrotome section.
        Reg Anesth Pain Med. 2002; 27: 150-156https://doi.org/10.1053/rapm.2002.29748
        • Enix D.E.
        • Scali F.
        • Pontell M.E.
        The cervical myodural bridge, a review of literature and clinical implications.
        J Can Chiropr Assoc. 2014; 58: 184-192
        • Figley C.R.
        • Stroman P.W.
        Investigation of human cervical and upper thoracic spinal cord motion: implications for imaging spinal cord structure and function.
        Magn Reson Med. 2007; 58: 185-189https://doi.org/10.1002/mrm.21260
        • Fyneface-Ogan S.
        Epidural Analgesia—Current Views and Approaches.
        InTech Open, 2012https://doi.org/10.5772/2167
        • Hirabayashi Y.
        • Saitoh K.
        • Fukuda H.
        • Igarashi T.
        • Shimizu R.
        • Seo N.
        Magnetic resonance imaging of the extradural space of the thoracic spine.
        Br J Anaesth. 1997; 79: 563-566https://doi.org/10.1093/bja/79.5.563
        • Eldabe S.
        • Buchser E.
        • Duarte R.V.
        Complications of spinal cord stimulation and peripheral nerve stimulation techniques: a review of the literature.
        Pain Med. 2016; 17: 325-336
        • Chan A.K.
        • Winkler E.A.
        • Jacques L.
        Rate of perioperative neurological complications after surgery for cervical spinal cord stimulation.
        J Neurosurg Spine. 2016; 25: 31-38
        • Gazelka H.M.
        • Freeman E.D.
        • Hooten W.M.
        • et al.
        Incidence of clinically significant percutaneous spinal cord stimulator lead migration.
        Neuromodulation. 2015; 18: 123-125
        • Ali R.
        • Chon J.
        • Mathews L.
        • Yu H.
        • Konrad P.
        Novel technique for insertion of cervical spinal cord stimulator percutaneous leads: technical note and institutional experience.
        World Neurosurg. 2018; 119: 118-122
        • Falowski S.
        • Ooi Y.C.
        • Sabesan A.
        • Sharan A.
        Spinal cord injury induced by a cervical spinal cord stimulator.
        Neuromodulation. 2011; 14: 34-36
        • Holsheimer J.
        • den Boer J.A.
        • Struijk J.J.
        • Rozeboom A.R.
        MR assessment of the normal position of the spinal cord in the spinal canal.
        AJNR Am J Neuroradiol. 1994; 15: 951-959
        • Morishita Y.
        • Naito M.
        • Hymanson H.
        • Miyazaki M.
        • Wu G.
        • Wang J.C.
        The relationship between the cervical spinal canal diameter and the pathological changes in the cervical spine.
        Eur Spine J. 2009; 18: 877-883https://doi.org/10.1007/s00586-009-0968-y
        • Pahapill P.A.
        A novel nonanchoring technique for implantation of paddle leads in the cervical spine with conscious sedation.
        Neuromodulation. 2015; 18: 472-477https://doi.org/10.1111/ner.12283
        • Deer T.R.
        • Levy R.M.
        • Kramer J.
        • et al.
        Comparison of paresthesia coverage of patient's pain: dorsal root ganglion vs. spinal cord stimulation. An ACCURATE study sub-analysis.
        Neuromodulation. 2019; 22: 930-936
        • Verrills P.
        • Mitchell B.
        • Vivian D.
        • Cusack W.
        • Kramer J.
        Dorsal root ganglion stimulation is paresthesia-independent: a retrospective study.
        Neuromodulation. 2019; 22: 937-942
        • Skaribas I.M.
        • Peccora C.
        • Skaribas E.
        Single S1 dorsal root ganglia stimulation for intractable complex regional pain syndrome foot pain after lumbar spine surgery: a case series.
        Neuromodulation. 2019; 22: 101-107
        • Chapman K.B.
        • Groenen P.S.
        • Vissers K.C.
        • van Helmond N.
        • Stanton-Hicks M.D.
        The pathways and processes underlying spinal transmission of low back pain: observations from dorsal root ganglion stimulation treatment.
        Neuromodulation. 2021; 24: 610-621https://doi.org/10.1111/ner.13150
        • Piedade G.S.
        • Vesper J.
        • Chatzikalfas A.
        • Slotty P.J.
        Cervical and high-thoracic dorsal root ganglion stimulation in chronic neuropathic pain.
        Neuromodulation. 2019; 22: 951-955
        • Morgalla M.H.
        • Fortunato M.
        • Lepski G.
        • Chander B.S.
        Dorsal root ganglion stimulation (DRGS) for the treatment of chronic neuropathic pain: a single-center study with long-term prospective results in 62 cases.
        Pain Physician. 2018; 21: E377-E387
        • Kretzschmar M.
        • Reining M.
        • Schwarz M.A.
        Three-year outcomes after dorsal root ganglion stimulation in the treatment of neuropathic pain after peripheral nerve injury of upper and lower extremities.
        Neuromodulation. 2021; 24: 700-707
        • Chapman K.B.
        • Kloosterman J.
        • Schor J.A.
        • Girardi G.E.
        • van Helmond N.
        • Yousef T.A.
        Objective improvements in peripheral arterial disease from dorsal root ganglion stimulation: a case series.
        Ann Vasc Surg. 2021; 74 (519.e7–519.e16)
        • Deer T.R.
        • Grider J.S.
        • Russo M.A.
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for the mitigation of complications of neurostimulation.
        Neuromodulation. 2021;
      2. Centers for Disease Control and Prevention. Guidelines Library. Updated February 28, 2017. Accessed May 5, 2021. https://www.cdc.gov/infectioncontrol/guidelines/index.htm

        • Bendel M.A.
        • O'Brien T.
        • Hoelzer B.C.
        • et al.
        Spinal cord stimulator related infections: findings from a multicenter retrospective analysis of 2737 implants.
        Neuromodulation. 2017; 20: 553-557https://doi.org/10.1111/ner.12636
        • Pahapill P.A.
        Incidence of revision surgery in a large cohort of patients with thoracic surgical three-column paddle leads: a retrospective case review.
        Neuromodulation. 2015; 18: 367-375https://doi.org/10.1111/ner.12239
        • Arocho-Quinones E.V.
        • Huang C.C.
        • Ward B.D.
        • Pahapill P.A.
        Care bundle approach to minimizing infection rates after neurosurgical implants for neuromodulation: a single-surgeon experience.
        World Neurosurg. 2019; 128: e87-e97https://doi.org/10.1016/j.wneu.2019.04.003
      3. Practice advisory for the prevention, diagnosis, and management of infectious complications associated with neuraxial techniques: an updated report by the American Society of Anesthesiologists Task Force on infectious complications associated with neuraxial techniques and the American Society of Regional Anesthesia and Pain Medicine.
        Anesthesiology. 2017; 126: 585-601
        • Esquer Garrigos Z.
        • Farid S.
        • Bendel M.A.
        • Sohail M.R.
        Spinal cord stimulator infection: approach to diagnosis, management, and prevention.
        Clin Infect Dis. 2020; 70: 2727-2735
        • Narouze S.
        • Benzon H.T.
        • Provenzano D.
        • et al.
        Interventional spine and pain procedures in patients on antiplatelet and anticoagulant medications (second edition): guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain.
        Reg Anesth Pain Med. 2018; 43: 225-262
        • Petraglia 3rd, F.W.
        • Farber S.H.
        • Gramer R.
        • et al.
        The incidence of spinal cord injury in implantation of percutaneous and paddle electrodes for spinal cord stimulation.
        Neuromodulation. 2016; 19: 85-90
        • Rosenow J.M.
        • Stanton-Hicks M.
        • Rezai A.R.
        • Henderson J.M.
        Failure modes of spinal cord stimulation hardware.
        J Neurosurg Spine. 2006; 5: 183-190
        • Mekhail N.A.
        • Mathews M.
        • Nageeb F.
        • Guirguis M.
        • Mekhail M.N.
        • Cheng J.
        Retrospective review of 707 cases of spinal cord stimulation: indications and complications.
        Pain Pract. 2011; 11: 148-153
        • Pope J.E.
        • Deer T.R.
        • Falowski S.
        • et al.
        Multicenter retrospective study of neurostimulation with exit of therapy by explant.
        Neuromodulation. 2017; 20: 543-552
        • Baranidharan G.
        • Bretherton B.
        • Richert G.
        • et al.
        Pocket pain, does location matter: a single-centre retrospective study of patients implanted with a spinal cord stimulator.
        Reg Anesth Pain Med. 2020; 45: 891-897
        • Deer T.R.
        • Russo M.
        • Grider J.S.
        • et al.
        The Neurostimulation Appropriateness Consensus Committee (NACC) recommendations for therapy salvage and persistent outcome optimization.
        Neuromodulation. 2021;
        • Mekhail N.
        • Levy R.M.
        • Deer T.R.
        • et al.
        Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.
        Lancet Neurol. 2020; 19: 123-134

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        • Erratum
          NeuromodulationVol. 25Issue 3
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            With regard to the article in the January 2022 issue entitled “The Neurostimulation Appropriateness Consensus Committee (NACC): Recommendations on Best Practices for Cervical Neurostimulation” (Neuromodulation 2022;25(1):35-52), the 27th author’s name was listed incorrectly. It should be “Miguel D. Attias, MD.” The authors regret the error.
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