Jason E. Pope reports research and consulting fees from Saluda Medical during the conduct of the study; consultancy for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil outside the submitted work; has received grant and research support from: Abbott, Flowonix, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil outside the submitted work; and is a minority shareholder of Vertos, Stimgenics, SPR Therapeutics, Saluda Medical, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, Abbott and Anesthetic Gas Reclamation. Ajay Antony serves as a consultant/speaker for Boston Scientific, Abbott, Nalu, PainTEQ, Saluda, Vertos; he has received research support from ViaDISC, Abbott, Boston scientific, PainTEQ, Saluda, and SPR. Erika A. Petersen has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical outside the submitted work, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos outside the submitted work. She holds stock options from SynerFuse and neuro42. There are no other relationships that might lead to a conflict of interest in the current study. Steven M. Rosen reports research and consulting fees from Saluda Medical during the conduct of the study. Dawood Sayed reports personal fees from Abbott, Boston Scientific, Flowonix, Medtronic, Nevro, Saluda, and Vertiflex, personal fees and stock options from Mainstay, SPR Therapeutics, PainTEQ, and Vertos, and stock options from Neuralace and Surgentec. Corey W. Hunter reports grants from Saluda Medical during the conduct of the study and consultancy fees from Genecentrix outside the submitted work. Johnathan H. Goree is a consultant for Saluda Medical, Abbott, and Stratus Medical and the recipient of research support paid to the institution by SPR Therapeutics and Mainstay Medical. Chau M. Vu serves as a consultant for Saluda Medical; consultant and principal investigator for PainTEQ. Harjot S. Bhandal serves as a consultant for Saluda Medica and principal investigator for Aurora Spine. Philip M. Shumsky serves as a consultant for Saluda Medical. Todd A. Bromberg reports research and consulting fees from Saluda Medical during the conduct of the study. He is also an advisor for and reports research fees from Medtronic. G. Lawson Smith and Christopher M. Lam report no conflicts of interest. Hemant Kalia serves as a consultant for Abbott, Nevro, Nalu, SPR Therapeutics, and Curonix. He serves on the medical advisory board for Abbott, Equanimity, Nervonik, and Virdio Health and reports research support from Abbott. Jennifer M. Lee is a consultant for and has received research support from Boston Scientific. Abeer Khurram, Ian Gould, and Dean M. Karantonis report being employees of Saluda Medical. Timothy R. Deer reports personal fees from Saluda Medical during the conduct of the study and consultancy for Axonics, Abbott, Nalu, Vertos, SpineThera, Mainstay, CornerLoc, Ethos, SPR Therapeutics, Medtronic, Boston Scientific, PainTEQ, Tissue Tech, Spinal Simplicity, and Avanos outside the submitted work. He is a minor equity holder of Saluda Medical, Nalu, SpineThera, Stimgenics, Vertiflex, Vertos, and Bioness and an advisory board member of Abbott, Vertos, Nalu, SPR Therapeutics, and Tissue Tech.

All subjects gave their informed consent for inclusion before they participated in the ECAP Study (NCT04319887, registered 24 March 2020 on ClinicalTrials.gov, first enrollment 29 October 2020). The ECAP Study was conducted in accordance with the United States Food and Drug Administration (FDA) regulatory requirements, good clinical practice (GCP, per ISO 14155), Western Institutional Review Board approval (WIRB), and the Declaration of Helsinki guided ethical principles.