Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain Article Swipe

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Richard Rauck , Eric Loudermilk , Simon Thomson , J. Paz , Louis Bojrab , John Noles , Jan Vesper , Joseph Atallah , Daniel Roth , Joseph Hegarty , Michel Prudhomme , Gregory M Phillips , Stephen G. Smith , Mohab Ibrahim , Channing D Willoughby , Jon B. Obray , Mayank Gupta , Julio Paez , Anthony Berg , Nathan J. Harrison , Paolo Maino , Praveen Mambalam , Matthew McCarty , Glyn Towlerton , Sarah Love‐Jones , Shakil Ahmed , Albert Lee , Binit Shah , Itay Goor‐Aryeh , Marc Russo , Nicolás Díaz Varela , Jeffrey B Phelps , J. Cid , Tacson Fernandez , Concepción Pérez , Douglas Keehn , Joshua M. Rosenow , Nameer Haider , Andrew G. Parrent , Melinda M. Lawrence , Peter Georgius , Laura Demartini , Agustin Mendiola , Vivek Mehta , R. Thoma , Atef F. Israel , Giuliano De Carolis , Sanjay Bhatia , Matthew Green , Armando Villarreal , Matthew T Crooks , Ryder P. Gwinn , Julie G. Pilitsis , Hitoaki Sato , Sergio Maldonado Vega , M. Gabriel Hillegass , Paul Carnes , Christian Scherer , Silviu Brill , James Yu , James Brennan , Kliment Gatzinsky , Annu Navani , Lee T Snook , Borja Mugabure Bujedo , Javier De Andrés Ares , Abel Murillo , Andrew Trobridge , Kamyar Assil , Jawad Ali Shah , Carroll McLeod , Joseph Buwembo , Olivier De Coster , Nathan Miller , Mehendra Sanapati , Medhat Mikhael , René Przkora , Norihiko Sukenaga , Louis J. Raso , Aaron Calodney , Luz Elena Cáceres Jerez , Takuya Uchiyama , Jan Willem Kallewaard , Brett Chandler , Fabián Piedimonte , Kenneth D. Candido , Tristan Weaver , Takashi Agari , David Holthouse , Rex Woon , Nileshkumar Patel , Kristen Lechleiter , Roshini Jain ·

YOU? · · 2023 · Open Access · · DOI: https://doi.org/10.2217/pmt-2022-0091

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).

Related Topics

Medicine

Physical Medicine And Rehabilitation

Transcutaneous Electrical Nerve Stimulation

Concepts

Medicine Chronic pain Spinal cord stimulation Term (time) Physical medicine and rehabilitation Stimulation Prospective cohort study Spinal cord Physical therapy Internal medicine Psychiatry Quantum mechanics Physics

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Type: article
Language: en
Landing Page: https://doi.org/10.2217/pmt-2022-0091
OA Status: hybrid
Cited By: 25
References: 47
Related Works: 10
OpenAlex ID: https://openalex.org/W4317868489

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DOI: https://doi.org/10.2217/pmt-2022-0091

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Title: Long-term Safety of Spinal Cord Stimulation Systems in A Prospective, Global Registry of Patients With Chronic Pain

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Language: en

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Publication year: 2023

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Publication date: 2023-01-24

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Authors: Richard Rauck, Eric Loudermilk, Simon Thomson, J. Paz, Louis Bojrab, John Noles, Jan Vesper, Joseph Atallah, Daniel Roth, Joseph Hegarty, Michel Prudhomme, Gregory M Phillips, Stephen G. Smith, Mohab Ibrahim, Channing D Willoughby, Jon B. Obray, Mayank Gupta, Julio Paez, Anthony Berg, Nathan J. Harrison, Paolo Maino, Praveen Mambalam, Matthew McCarty, Glyn Towlerton, Sarah Love‐Jones, Shakil Ahmed, Albert Lee, Binit Shah, Itay Goor‐Aryeh, Marc Russo, Nicolás Díaz Varela, Jeffrey B Phelps, J. Cid, Tacson Fernandez, Concepción Pérez, Douglas Keehn, Joshua M. Rosenow, Nameer Haider, Andrew G. Parrent, Melinda M. Lawrence, Peter Georgius, Laura Demartini, Agustin Mendiola, Vivek Mehta, R. Thoma, Atef F. Israel, Giuliano De Carolis, Sanjay Bhatia, Matthew Green, Armando Villarreal, Matthew T Crooks, Ryder P. Gwinn, Julie G. Pilitsis, Hitoaki Sato, Sergio Maldonado Vega, M. Gabriel Hillegass, Paul Carnes, Christian Scherer, Silviu Brill, James Yu, James Brennan, Kliment Gatzinsky, Annu Navani, Lee T Snook, Borja Mugabure Bujedo, Javier De Andrés Ares, Abel Murillo, Andrew Trobridge, Kamyar Assil, Jawad Ali Shah, Carroll McLeod, Joseph Buwembo, Olivier De Coster, Nathan Miller, Mehendra Sanapati, Medhat Mikhael, René Przkora, Norihiko Sukenaga, Louis J. Raso, Aaron Calodney, Luz Elena Cáceres Jerez, Takuya Uchiyama, Jan Willem Kallewaard, Brett Chandler, Fabián Piedimonte, Kenneth D. Candido, Tristan Weaver, Takashi Agari, David Holthouse, Rex Woon, Nileshkumar Patel, Kristen Lechleiter, Roshini Jain

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OA URL: https://doi.org/10.2217/pmt-2022-0091

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Concepts: Medicine, Chronic pain, Spinal cord stimulation, Term (time), Physical medicine and rehabilitation, Stimulation, Prospective cohort study, Spinal cord, Physical therapy, Internal medicine, Psychiatry, Quantum mechanics, Physics

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Cited by: 25

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Related works (count): 10

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