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Multicenter Study
. 2025 Jan;25(1):e13407.
doi: 10.1111/papr.13407. Epub 2024 Sep 11.

Low-energy differential target multiplexed SCS derivative reduces pain and improves quality of life through 12 months in patients with chronic back and/or leg pain

Jeffery Peacock  1 , David Provenzano  2 , Michael Fishman  3 , Kasra Amirdelfan  4 , Todd Bromberg  5 , Todd Schmidt  6 , Thomas White  7 , Prabhdeep Grewal  8 , Rafael Justiz  9 , Aaron Calodney  10 , Amr El-Naggar  11 , Binit Shah  12 , Michael Esposito  13 , Kliment Gatzinsky  14 , Jan Willem Kallewaard  15   16 , Lawrence Poree  17 , Andrew Cleland  18 , Calysta Rice  18 , Erin Theis  18 , Kate Noel  18 , Maddie LaRue  18
Affiliations
Multicenter Study

Low-energy differential target multiplexed SCS derivative reduces pain and improves quality of life through 12 months in patients with chronic back and/or leg pain

Jeffery Peacock et al. Pain Pract. 2025 Jan.

Abstract

Introduction: Energy-reducing spinal cord stimulation (SCS) approaches have the potential to impact patient experience with rechargeable and non-rechargeable SCS devices through reducing device recharge time or enhancing device longevity. This prospective, multi-center study evaluated the safety, effectiveness, and actual energy usage of differential target multiplexed (DTM) endurance therapy, a reduced energy DTM SCS derivative.

Methods: Subjects who reported an overall pain visual analog score (VAS) of ≥6/10 cm and an Oswestry Disability Index score of 21-80 out of 100 at baseline with moderate to severe chronic, intractable back and/or leg pain were eligible. Evaluation visits occurred at 1, 3, 6, and 12 months post-device activation. The primary objective was to characterize change in overall pain intensity, as measured by VAS, from baseline to 3-month visit.

Results: Fifty-seven subjects enrolled at 12 US sites from November 2020 through June 2021, 35 were implanted with a rechargeable SCS device, and 27 completed the 12-month visit. Subjects experienced a 50.4% mean reduction in overall pain from baseline at the 3-month follow-up that was sustained through 12 months. Additional outcomes including changes in overall, back, and leg pain intensity, quality of life, disability, therapy satisfaction, safety, and current battery usage are shown through 12-month follow-up.

Conclusion: The use of DTM endurance SCS therapy in this study resulted in reductions in pain relief through 12 months, demonstrating that energy-reducing stimulation patterns can provide clinical benefit. Clinically effective, reduced energy SCS derivatives have the potential to impact patient experience through either reduced recharge requirements or increased device longevity.

Keywords: back pain; chronic pain; leg pain; reduced energy; spinal cord stimulation.

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Conflict of interest statement

K. Amirdelfan reports consulting fees and research grant to institution from Medtronic. A. Calodney reports consulting fees to institution from PainTeq and TissueTech, payment/honoraria to institution from Medtronic, Stryker, Nevro, Boston Scientific, and Saluda. A. Calodney is an Editorial Board member of Pain Practice and a co‐author of this article. To minimize bias, A. Calodney was excluded from all editorial decision making related to the acceptance of this article for publication. M. Esposito reports consulting fees from Medtronic, Abbott, Nevro, Boston Scientific, Stimwave/Curonix, and Biotronik; payment/honoraria from Medtronic, Abbott, Nevro, Boston Scientific, Stimwave/Curonix, and Biotronik; travel support from Abbott and Boston Scientific; and advisory board participation at Abbott. M. Fishman reports grants to institution from Abbott, Biotronik, Nalu, Mainstay Medical, Saluda Medical, PainQx, InterAxon, Ethos Lab, Biowave, and Thermaquil, consulting fees from Biotronik, Bixton Biosciences, Medtronic, Foundation Fusion Solutions, payment/honoraria from Medtronic, payment for expert testimony from Nevro, leadership role at the North American Neuromodulation Society, and stock/stock options from Aurora Spine, Thermaquil, Celeri Health. K. Gatzinsky reports payment/honoraria from Boston Scientific and advisory board participation at Medtronic, Nevro, and Boston Scientific. P. K. Grewal reports consulting fees from Medtronic and advisory board participation at Medtronic. J. W. Kallewaard reports consulting fees from Medtronic, Saluda, Boston Scientific, Nevro, and Abbott. J. Peacock reports payment for expert testimony from Warhawk Legal. L. Poree reports consulting fees from Medtronic, Nalu, and Saluda, and stock/stock options from Saluda and Nalu. D. Provenzano reports grants/research funding to institution from Avanos, Medtronic, Stimgenics, Boston Scientific, Nevro, and Abbott and consulting fees from Avanos, Medtronic, SI Bone, Boston Scientific and Nevro. T. White reports consulting fees from Medtronic, payment/honoraria from Medtronic, payment for expert testimony from multiple law firms, travel support from Medtronic, and leadership roles at North Pines Surgery Center and Sprintz Center for Pain. T. Bromberg reports consulting fees from Medtronic, payment/honoraria from Medtronic and Saluda, and advisory board participation at Medtronic. T. Schmidt, R. Justiz, B. Shah, and A. El‐Naggar have no disclosures. A. Cleland, E. Theis, K. Noel, and M. LaRue report stock/stock options from Medtronic. A. Cleland, C. Rice, E. Theis, K. Noel, and M. LaRue are employees of Medtronic.

Figures

FIGURE 1
FIGURE 1
Subject enrollment and disposition. Flowchart showing subject enrollment and follow‐up disposition from enrollment through 12‐month follow‐up visit. Enrollment and disposition information shown for 3‐, 6‐, and 12‐month follow‐ups are presented only for the per‐protocol analysis set.
FIGURE 2
FIGURE 2
Visual analog scale (VAS) scores for overall, back, and leg pain. Values shown represent mean VAS scores (scale of 0–10, with 10 being the most pain) from per‐protocol subjects at baseline, 3‐month (n = 32), 6‐month (n = 29), and 12‐month (n = 27) follow‐ups. Error bars represent standard error (SE).
FIGURE 3
FIGURE 3
Responder rate for overall, back, and leg pain. Bar graphs show average responder rate (≥50% reduction in pain, %) in per‐protocol subjects at the 3‐ (n = 32) and 12‐month (n = 27) follow‐up visits. Error bars represent 95% confidence intervals (95% CI).
FIGURE 4
FIGURE 4
Oswestry Disability Index (ODI) scores. Bar graphs represent the proportion of subjects (%) in the per‐protocol analysis set reporting minimal, moderate, severe, crippled, or bed‐bound disability status on the ODI questionnaire at baseline, 3‐month (n = 32), and 12‐month (n = 27) follow‐ups. The highlighted percentages at each timepoint represent the proportion of subjects (%) reporting minimal to moderate disability.
FIGURE 5
FIGURE 5
EuroQol‐5D (EQ‐5D) scores. Bar graphs represent the proportion of subjects (%) in the per‐protocol analysis set reporting that health state is better, same, mixed, or worse on the EQ‐5D questionnaire at 3‐month (n = 32) and 12‐month (n = 27) follow‐ups. The highlighted proportion of subjects (%) at each timepoint represents subjects who reported that health state is better at the indicated timepoint.
FIGURE 6
FIGURE 6
Subject satisfaction. Bar graphs represent the proportion of subjects (%) in the per‐protocol analysis reporting that they are very satisfied, somewhat satisfied, neutral, somewhat unsatisfied, or very unsatisfied with their therapy at 3‐month (n = 32) and 12‐month (n = 27) follow‐ups. The highlighted percentages represent the proportion of subjects (%) reporting that they are very satisfied or somewhat satisfied with their therapy at the indicated timepoint.
FIGURE 7
FIGURE 7
Patient Global Impression of Change (PGIC). Bar graphs represent the proportion of subjects (%) in the per‐protocol analysis reporting no change, almost the same, a little better, somewhat better, moderately better, better, or a great deal better at 3‐month (n = 32) and 12‐month (n = 27) follow‐ups. The highlighted percentages at each timepoint represent the proportion of subjects (%) reporting feeling better or a great deal better.
FIGURE 8
FIGURE 8
Longevity modeling on Vanta™ recharge‐free neurostimulator at 12 months. Individual subject programing data were entered into the “Estimate Battery Longevity” feature on the Clinician Programmer Application of the commercial Vanta™ neurostimulator system to generate predictions for average Vanta™ battery longevity (years). Data were inputted for low (<600 Ω), medium (<600–1200 Ω), or high (>1200 Ω) impedance values reported from subjects at 12‐months. Error bars represent SE.
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