Durable multimodal and holistic response for physiologic closed-loop spinal cord stimulation supported by objective evidence from the EVOKE double-blind randomized controlled trial.

Autor:	Kapural L; Carolinas Pain Institute, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA., Mekhail NA; Pain Management, Cleveland Clinic, Cleveland, Ohio, USA., Costandi S; Pain Management, Cleveland Clinic, Cleveland, Ohio, USA., Gilmore C; Center for Clinical Research, Winston-Salem, North Carolina, USA., Pope JE; Evolve Restorative Center, Santa Rosa, California, USA., Li S; Premier Pain Centers, Shrewsbury, New Jersey, USA., Hunter CW; Ainsworth Institute of Pain Management, New York, New York, USA., Poree L; University of California at San Francisco, San Francisco, California, USA., Staats PS; Premier Pain Centers, Shrewsbury, New Jersey, USA., Taylor RS; Institute of Health and Well Being, University of Glasgow, Glasgow, UK., Eldabe S; Pain Medicine, James Cook Univesity Hospital, Middlesbrough, UK., Kallewaard JW; Anesthesiology and Pain Medicine, Rijnstate Hospital, Arnhem, The Netherlands.; Anesthesiology and Pain Medicine, Amsterdam University Medical Centre, Amsterdam, The Netherlands., Thomson S; Pain Medicine and Neuromodulation, Mid & South Essex University Hospitals, Essex, UK., Petersen EA; University of Arkansas for Medical Sciences, Little Rock, Arkansas, USA., Sayed D; The University of Kansas Medical Center, Kansas City, Kansas, USA., Deer TR; Spine and Nerve Center of the Virginias, West Virginia University - Health Sciences Campus, Morgantown, West Virginia, USA., Antony A; The Orthopaedic Institute, Gainesville, Florida, USA., Budwany R; West Virginia University, Morgantown, West Virginia, USA., Leitner A; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Soliday N; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia., Duarte RV; Saluda Medical Pty Ltd, Artarmon, New South Wales, Australia rui.duarte@liverpool.ac.uk.; Health Data Science, University of Liverpool, Liverpool, UK., Levy RM; Anesthesia Pain Care Consultants, Boca Raton, Florida, USA.
Jazyk:	angličtina
Zdroj:	Regional anesthesia and pain medicine [Reg Anesth Pain Med] 2024 Apr 02; Vol. 49 (4), pp. 233-240. Date of Electronic Publication: 2024 Apr 02.
DOI:	10.1136/rapm-2023-104639
Abstrakt:	Introduction: Chronic pain patients may experience impairments in multiple health-related domains. The design and interpretation of clinical trials of chronic pain interventions, however, remains primarily focused on treatment effects on pain intensity. This study investigates a novel, multidimensional holistic treatment response to evoked compound action potential-controlled closed-loop versus open-loop spinal cord stimulation as well as the degree of neural activation that produced that treatment response. Methods: Outcome data for pain intensity, physical function, health-related quality of life, sleep quality and emotional function were derived from individual patient level data from the EVOKE multicenter, participant, investigator, and outcome assessor-blinded, parallel-arm randomized controlled trial with 24 month follow-up. Evaluation of holistic treatment response considered whether the baseline score was worse than normative values and whether minimal clinical important differences were reached in each of the domains that were impaired at baseline. A cumulative responder score was calculated to reflect the total minimal clinical important differences accumulated across all domains. Objective neurophysiological data, including spinal cord activation were measured. Results: Patients were randomized to closed-loop (n=67) or open-loop (n=67). A greater proportion of patients with closed-loop spinal cord stimulation (49.3% vs 26.9%) were holistic responders at 24-month follow-up, with at least one minimal clinical important difference in all impaired domains (absolute risk difference: 22.4%, 95% CI 6.4% to 38.4%, p=0.012). The cumulative responder score was significantly greater for closed-loop patients at all time points and resulted in the achievement of more than three additional minimal clinical important differences at 24-month follow-up (mean difference 3.4, 95% CI 1.3 to 5.5, p=0.002). Neural activation was three times more accurate in closed-loop spinal cord stimulation (p<0.001 at all time points). Conclusion: The results of this study suggest that closed-loop spinal cord stimulation can provide sustained clinically meaningful improvements in multiple domains and provide holistic improvement in the long-term for patients with chronic refractory pain. Trial Registration Number: NCT02924129. Competing Interests: Competing interests: LK reports receiving grants from Nevro, Neuros, Avanos, Medtronic, Neuralace, and Xalud Therapeutics and financial support from Nevro, Avanos, and Saluda Medical. NM reports receiving grants from Neuros and Mesoblast, as well as consulting as a medical monitor for Saluda Medical, Nevro, Vivex, Mainstay, and Vertos. SC reports receiving grants from Saluda Medical, Vertos, Mainstay, and Vivex. CG reports personal fees and other from SPR, and personal fees from Nevro, Nalu, Biotronik, Boston Scientific, Saluda Medical, and Shiratronics. JP serves as a consultant for Abbott, Medtronic, Saluda Medical, Flowonix, SpineThera, Vertos, Vertiflex, SPR Therapeutics, Tersera, Aurora, Spark, Ethos, Biotronik, Mainstay, WISE, Boston Scientific, and Thermaquil; has received grant and research support from: Abbott, Flowonix, Saluda Medical, Aurora, Painteq, Ethos, Muse, Boston Scientific, SPR Therapeutics, Mainstay, Vertos, AIS, and Thermaquil; and is a shareholder of Vertos, SPR Therapeutics, Painteq, Aurora, Spark, Celeri Health, Neural Integrative Solutions, Pacific Research Institute, Thermaquil, and Anesthetic Gas Reclamation. SL reports receiving grants from Avanos, Boston Scientific, Nalu Medical, SPR Therapeutics, Saluda Medical, Averitas Pharma, Biotronik, SGX Therapeutics, and PainTeq, as well as serving as a consultant for Abbott, Avanos, Boston Scientific, Nevro, SPR Therapeutics, Averitas Pharma, Biotronik, Nalu Medical, PainTeq, and Saluda Medical, as well as holding stock options for Nalu Medical. CH has received consultancy fees from Saluda Medical and Genecentrix. PSS has received consultancy fees from Medtronic, Saluda Medical, Nalu, and Biotronic and has stock options from Saluda Medical and Nalu. RST reports consultancy fees from Medtronic, Nevro and Saluda Medical. SE reports consultancy fees from Medtronic, Mainstay Medical, Boston Scientific, and Abbott. He has received department research funding from the National Institute of Health Research, Medtronic and Nevro. JWK is an advisory board member for Boston Scientific, Medtronic, Abbott, and Saluda Medical. ST has received consultancy fees from Boston Scientific, Mainstay Medical, and Saluda Medical. He has received department research funding from the National Institute for Health Research, Boston Scientific, Saluda Medical, and Mainstay Medical. EP has received research support from Mainstay, Medtronic, Neuros Medical, Nevro Corp, ReNeuron, SPR, and Saluda Medical, as well as personal fees from Abbott Neuromodulation, Biotronik, Medtronic Neuromodulation, Nalu, Neuros Medical, Nevro, Presidio Medical, Saluda Medical, and Vertos. She holds stock options from SynerFuse and neuro42. DS is a consultant for Abbott, Medtronic, Nevro, SPR, Vertos, PainTEQ, and Saluda Medical and has received research funding from and holds minority equity in Vertos. TD is a consultant for Abbott, Vertos, SpineThera, Saluda Medical, Cornerloc, SPR Therapeutics, PainTeq, Spinal Simplicity, and Biotronik. He has minor equity in form of stock options for Vertos, Saluda Medical, Cornerloc, Nalu, PainTeq, and Spinal Simplicity, and minor equity in common stock for SpineThera, and Ethos. He is an advisory board member or participates on a data safety monitoring board for Abbott, Vertos, SPR Therapeutics, and Biotronik. AA reports consultancy fees from Boston Scientific. AL, NS and RD are employees of Saluda Medical. RD has previously received consultancy fees from Mainstay Medical, Medtronic Ltd, and Saluda Medical. RL is an uncompensated consultant for Nalu, Saluda Medical, and Mainstay Medical and has stock options from Nalu and Saluda Medical obtained before 2019, not exercisable through the duration of his term as International Neuromodulation Society President and editor-in-chief of the journal Neuromodulation: Technology at the Neural Interface. (© American Society of Regional Anesthesia & Pain Medicine 2024. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu