Abstract
Introduction: The field of neurostimulation for the treatment of chronic pain is a rapidly developing area of medicine. Although neurostimulation therapies have advanced significantly as a result of technologic improvements, surgical planning, device placement, and postoperative care are of equal importance to optimize outcomes. This Neurostimulation Appropriateness Consensus Committee (NACC) project intends to provide evidence-based guidance for these often-overlooked areas of neurostimulation practice. Materials and Methods: Authors were chosen based on 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 the last NACC publication in 2017 to the present. Identified studies were graded using the United States Preventive Services Task Force criteria for evidence and certainty of net benefit. Recommendations are based on evidence strength and consensus when evidence was scant. Results: This NACC project provides guidance on preoperative assessment, intraoperative techniques, and postoperative management in the form of consensus points with supportive evidence. These results are based on grade of evidence, strength of consensus, and expert opinion. Conclusions: The NACC has given guidance for a surgical plan that encompasses the patient journey from the planning stage through the surgical experience and postoperative care. The overall recommendations are designed to improve efficacy and the safety of patients undergoing these neuromodulation procedures and are intended to apply throughout the international community.
| Original language | English |
|---|---|
| Pages (from-to) | 1-34 |
| Number of pages | 34 |
| Journal | Neuromodulation |
| Volume | 25 |
| Issue number | 1 |
| DOIs | |
| State | Published - Jan 2022 |
Bibliographical note
Publisher Copyright:© 2021 International Neuromodulation Society
Funding
Although training in neuromodulation is clearly a worldwide endeavor, the following is an overview of the training process within the United States. Traditionally, surgical training within neuromodulation has been achieved through the Accredited Council of Graduate Medical Education (ACGME) residency and fellowship training programs, societal engagement through cadaver laboratory training courses and mentorship programs, and industry-sponsored courses for implantable therapies. However, despite ACGME guidelines, there remains significant variability within and across the specialties delivering education and training for implantable neuromodulation therapies. Furthermore, because of unmet needs in training, industry sponsorship plays a larger-than-desired role in surgical education and training. This presents a separate challenge with respect to conflict of interest and bias. In 2014, Gharibo et al 184 reported that 89.1% of pain fellowship program directors ranked fellowship as the “most valuable” source of fellow SCS training, with manufacturer-sponsored workshops ranked second. 181–188 Source(s) of financial support: This NACC publication was supported by the International Neuromodulation Society (INS) and no authors were paid for their contributions. Sarah Staples, MA, ELS, assisted with manuscript preparation as a part-time contractor for INS.Conflict of Interest: The following authors reported no conflict of interest: Marc A. Russo, Jay S. Grider, Jonathan M. Hagedorn, Stana Bojanic, Alexander L. Green, N. Nick Knezevic, Stefan Schu, Jay M. Shah, Thomas P. Pittelkow, Asokumar Buvanendran, Kenneth Chapman, Jose Manuel Gonzalez, Navdeep Jassal, Peter Pahapill, Pankaj Mehta, Alessandro Dario, Fabian Piedimonte, and Robert M. Levy. Timothy R. Deer consults for Abbott, Axionics, Saluda, Mainstay, Nalu, Stimgenics, and Nevro; holds a patent with Abbott; is on the advisory boards of Abbott and Nalu; owns stock options from Axionics, Saluda, and Nalu; and has institutional research grants from Abbott, Saluda, and Mainstay. Jason Pope serves as a consultant, is on the advisory boards of, and conducts research for Ethos Labs, Flowonix, Saluda, PainTeq, Aurora Spine, Thermaquil, Abbott, Vertiflex, Vertos, and SPARK; owns stock in PainTeq, Aurora Spine, Thermaquil, Spine Thera, AGR, NIS, Vertos, Celeri Health, and SPARK; receives royalties from Aurora Spine; consults for Medtronic, Boston Scientific, and WISE; conducts research for Celeri Health and Boston Scientific; and serves on the advisory board of Spine Thera. Philippe Rigoard consults for Medtronic, Boston Scientific, Abbott, and Allergan, and his institution does clinical research for Medtronic and Boston Scientific. Ramana Naidu reports consulting fees from Abbott, Boston Scientific, and Nalu, outside the submitted work. Denis G. Patterson reports personal fees from Abbott Medical, Saluda, Nevro, Biotronik, and Nuvectra, outside the submitted work. Derron Wilson reports personal fees from Abbott and Boston Scientific, outside the submitted work. Timothy R. Lubenow reports consulting fees for Abbott, Medtronic, Nevro, Boston Scientific, and Vertiflex; payment or honoraria from Abbott, Vertiflex, and Medtronic; and payment for expert testimony as a plaintiff and defense expert. Samir J. Sheth reports personal fees from Medtronic and Boston Scientific, outside the submitted work. Rany Abdallah reports personal fees from Medtronic, Abbott, SPR Therapeutics, and Avanos during the conduct of the study. Harold Nijhuis reports grants and personal fees from Abbott and personal fees from Saluda, outside the submitted work. Ricardo Vallejo has conducted research for Avanos, and his startup company, Stimgenics, was recently acquired by Medtronic. No royalties or licenses are pending. Michael E. Harned received grants for fellowship education from Medtronic and Abbott and research funding from Nevro. Shachi Patel has received consulting fees from Abbott, outside of the submitted work. Natalie Strand consults for Abbott. Fabian Piedimonte received personal fees from Medtronic and Abbott, outside the submitted work. Robert M. Levy is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, and not exercisable through the duration of his term as INS president and editor-in-chief of the journal, Neuromodulation: Technology at the Neural Interface. Source(s) of financial support: This NACC publication was supported by the International Neuromodulation Society (INS) and no authors were paid for their contributions. Sarah Staples, MA, ELS, assisted with manuscript preparation as a part-time contractor for INS. Conflict of Interest: The following authors reported no conflict of interest: Marc A. Russo, Jay S. Grider, Jonathan M. Hagedorn, Stana Bojanic, Alexander L. Green, N. Nick Knezevic, Stefan Schu, Jay M. Shah, Thomas P. Pittelkow, Asokumar Buvanendran, Kenneth Chapman, Jose Manuel Gonzalez, Navdeep Jassal, Peter Pahapill, Pankaj Mehta, Alessandro Dario, Fabian Piedimonte, and Robert M. Levy. Timothy R. Deer consults for Abbott, Axionics, Saluda, Mainstay, Nalu, Stimgenics, and Nevro; holds a patent with Abbott; is on the advisory boards of Abbott and Nalu; owns stock options from Axionics, Saluda, and Nalu; and has institutional research grants from Abbott , Saluda , and Mainstay . Jason Pope serves as a consultant, is on the advisory boards of, and conducts research for Ethos Labs, Flowonix, Saluda, PainTeq, Aurora Spine, Thermaquil, Abbott, Vertiflex, Vertos, and SPARK; owns stock in PainTeq, Aurora Spine, Thermaquil, Spine Thera, AGR, NIS, Vertos, Celeri Health, and SPARK; receives royalties from Aurora Spine; consults for Medtronic, Boston Scientific, and WISE; conducts research for Celeri Health and Boston Scientific; and serves on the advisory board of Spine Thera. Philippe Rigoard consults for Medtronic, Boston Scientific, Abbott, and Allergan, and his institution does clinical research for Medtronic and Boston Scientific. Ramana Naidu reports consulting fees from Abbott, Boston Scientific, and Nalu, outside the submitted work. Denis G. Patterson reports personal fees from Abbott Medical, Saluda, Nevro, Biotronik, and Nuvectra, outside the submitted work. Derron Wilson reports personal fees from Abbott and Boston Scientific, outside the submitted work. Timothy R. Lubenow reports consulting fees for Abbott, Medtronic, Nevro, Boston Scientific, and Vertiflex; payment or honoraria from Abbott, Vertiflex, and Medtronic; and payment for expert testimony as a plaintiff and defense expert. Samir J. Sheth reports personal fees from Medtronic and Boston Scientific, outside the submitted work. Rany Abdallah reports personal fees from Medtronic, Abbott, SPR Therapeutics, and Avanos during the conduct of the study. Harold Nijhuis reports grants and personal fees from Abbott and personal fees from Saluda, outside the submitted work. Ricardo Vallejo has conducted research for Avanos, and his startup company, Stimgenics, was recently acquired by Medtronic. No royalties or licenses are pending. Michael E. Harned received grants for fellowship education from Medtronic and Abbott and research funding from Nevro . Shachi Patel has received consulting fees from Abbott, outside of the submitted work. Natalie Strand consults for Abbott. Fabian Piedimonte received personal fees from Medtronic and Abbott, outside the submitted work. Robert M. Levy is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, and not exercisable through the duration of his term as INS president and editor-in-chief of the journal, Neuromodulation: Technology at the Neural Interface.
| Funders |
|---|
| Accredited Council of Graduate Medical Education |
| International Neuromodulation Society |
| Saluda |
| Technology at the Neural Interface |
| Yaroslav-the-Wise Novgorod State University |
| Abbott Laboratories |
| Medtronic |
| Allergan Incorporated |
| Boston Scientific Neuromodulation Corporation |
| Saluda Medical |
| Nevro Corporation |
Keywords
- Best practices
- consensus
- neurostimulation
- spinal cord stimulation
- surgical technique
ASJC Scopus subject areas
- Neurology
- Clinical Neurology
- Anesthesiology and Pain Medicine
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