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Pain Pract. 2021 Jul;21(6):680-691. doi: 10.1111/papr.13008. Epub 2021 May 2.
ECAP-Controlled Closed-Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24-Months: Final Results of the Prospective, Multicenter, Open-Label Avalon Study
Charles Brooker 1 2, Marc Russo 3, Michael J Cousins 1 2, Nathan Taylor 1 2, Lewis Holford 1 2, Rebecca Martin 1, Tillman Boesel 4, Richard Sullivan 5, Erin Hanson 6, Gerrit Eduard Gmel 6, Nastaran Hesam Shariati 6, Lawrence Poree 7, John Parker 6 8
Affiliations expand
PMID: 33768664 PMCID: PMC8359972 DOI: 10.1111/papr.13008
Free PMC article
Abstract
Introduction: Chronic pain is a major public health concern, as is the associated use of opioid medications, highlighting the importance of alternative treatments, such as spinal cord stimulation (SCS). Here, we present the final 24-month results of the Avalon study, which investigated the use of the first closed-loop SCS system in patients with chronic pain. The system measures the evoked compound action potentials (ECAPs) elicited by each stimulus pulse and drives a feedback loop to maintain the ECAP amplitude near constant.
Methods: Fifty patients were implanted with the Evoke system (Saluda Medical) and followed over 24-months. Pain, quality of life (QOL), function, sleep, and medication use were collected at baseline and each scheduled visit. ECAP amplitudes and programming adjustments were also monitored.
Results: At 24 months, responder rates (≥ 50% pain reduction) and high responder rates (≥ 80% pain reduction) for overall pain were 89.5% and 68.4%, respectively, the latter up from 42.2% at 3 months. Significant improvements from baseline were observed in QOL, function, and sleep over the 24 months, including ≥ 80% experiencing a minimally important difference in QOL and > 50% experiencing a clinically significant improvement in sleep. At 24 months, 82.8% of patients with baseline opioid use eliminated or reduced their opioid intake. Over the course of the study, reprogramming need fell to an average of less than once a year.
Conclusion: Over a 24-month period, the Evoke closed-loop SCS maintained its therapeutic efficacy despite a marked reduction in opioid use and steady decrease in the need for reprogramming.
Keywords: Chronic; closed-loop SCS; evoke; evoked compound action potential; feedback; opioid; pain; spinal cord stimulation.
Pain Pract. 2021 Jul;21(6):680-691. doi: 10.1111/papr.13008. Epub 2021 May 2.
ECAP-Controlled Closed-Loop Spinal Cord Stimulation Efficacy and Opioid Reduction Over 24-Months: Final Results of the Prospective, Multicenter, Open-Label Avalon Study
Charles Brooker 1 2, Marc Russo 3, Michael J Cousins 1 2, Nathan Taylor 1 2, Lewis Holford 1 2, Rebecca Martin 1, Tillman Boesel 4, Richard Sullivan 5, Erin Hanson 6, Gerrit Eduard Gmel 6, Nastaran Hesam Shariati 6, Lawrence Poree 7, John Parker 6 8
Affiliations expand
PMID: 33768664 PMCID: PMC8359972 DOI: 10.1111/papr.13008
Free PMC article
Abstract
Introduction: Chronic pain is a major public health concern, as is the associated use of opioid medications, highlighting the importance of alternative treatments, such as spinal cord stimulation (SCS). Here, we present the final 24-month results of the Avalon study, which investigated the use of the first closed-loop SCS system in patients with chronic pain. The system measures the evoked compound action potentials (ECAPs) elicited by each stimulus pulse and drives a feedback loop to maintain the ECAP amplitude near constant.
Methods: Fifty patients were implanted with the Evoke system (Saluda Medical) and followed over 24-months. Pain, quality of life (QOL), function, sleep, and medication use were collected at baseline and each scheduled visit. ECAP amplitudes and programming adjustments were also monitored.
Results: At 24 months, responder rates (≥ 50% pain reduction) and high responder rates (≥ 80% pain reduction) for overall pain were 89.5% and 68.4%, respectively, the latter up from 42.2% at 3 months. Significant improvements from baseline were observed in QOL, function, and sleep over the 24 months, including ≥ 80% experiencing a minimally important difference in QOL and > 50% experiencing a clinically significant improvement in sleep. At 24 months, 82.8% of patients with baseline opioid use eliminated or reduced their opioid intake. Over the course of the study, reprogramming need fell to an average of less than once a year.
Conclusion: Over a 24-month period, the Evoke closed-loop SCS maintained its therapeutic efficacy despite a marked reduction in opioid use and steady decrease in the need for reprogramming.
Keywords: Chronic; closed-loop SCS; evoke; evoked compound action potential; feedback; opioid; pain; spinal cord stimulation.
