• Neuromodulation · Jan 2022

    Multicenter Study

    Ultra-Low Energy Cycled Burst Spinal Cord Stimulation Yields Robust Outcomes in Pain, Function, and Affective Domains: A Subanalysis From Two Prospective, Multicenter, International Clinical Trials.

    • Timothy Deer, Derron Wilson, David Schultz, Steven Falowski, Ed Tavel, Gregory Moore, Robert Heros, Denis Patterson, Marie Fahey, Robyn Capobianco, and Magdalena Anitescu.
    • The Spine and Nerve Center of the Virginias, Charleston, WV, USA. Electronic address: doctdeer@aol.com.
    • Neuromodulation. 2022 Jan 1; 25 (1): 137-144.

    IntroductionDeRidder's burst stimulation design has become a key spinal cord stimulation (SCS) waveform because it reduces the intensity of pain as well as its associated emotional distress. The brain pathways underlying these outcomes may also allow for the effects of stimulation to carry over after stimulation is turned off, making it amenable to intermittent application. Here, the utility of intermittently cycled burst was evaluated using data from two large real-world prospective studies (TRIUMPH, REALITY).Materials And MethodsSubjects used intermittent dosing in a 1:3 ratio (30 sec on, 90 sec off; N = 100) in TRIUMPH and 1:12 ratio in REALITY (30-sec on, 360-sec off; N = 95) for six months. Pain intensity (0-10 numeric rating scale), pain-related emotions on the pain catastrophizing scale (PCS), and physical function on PROMIS questionnaires were compared with preimplant baseline ratings and by group.ResultsIn both groups, mean pain intensity decreased by nearly 50% relative to baseline, PCS scores significantly decreased, and physical function improved. Importantly, no differences between the 1:3 and 1:12 groups were identified. A high proportion, 80% and 77% of the 1:3 and 1:12 groups, respectively, were considered responders on a multiple measures. No adverse events were associated with intermittent stimulation.DiscussionIntermittent cycling of burst SCS lowers the overall electric charge delivered to the spinal cord and preserves battery consumption, without compromising pain relief and associated symptoms.Copyright © 2021 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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