• Marc A Russo, Willem Volschenk, Dominic Bailey, Danielle M Santarelli, Elizabeth Holliday, Daniel Barker, Jason Dizon, and Brett Graham.
• Hunter Pain Specialists, Broadmeadow, New South Wales, Australia; Genesis Research Services, Broadmeadow, New South Wales, Australia; School of Biomedical Sciences and Pharmacy, College of Health, Medicine and Wellbeing, University of Newcastle, Callaghan, New South Wales, Australia; Hunter Medical Research Institute, New Lambton Heights, New South Wales, Australia. Electronic address: algoguy@gmail.com.
• Neuromodulation. 2024 Oct 21.

ObjectivesThe aim of this study was to evaluate the effectiveness and safety of a novel subperception spinal cord stimulation (SCS) waveform paradigm designed to target the dorsal horn dendrites for treating chronic neuropathic low back pain (LBP). The final 12-month results are reported here.Materials And MethodsTwenty-seven participants were implanted with a commercial SCS system. Devices were programmed to deliver the waveform (frequency 100 Hz, pulse width 1000 μsec, T9-T10 disk bipole) at decreasing stimulation perception threshold amplitudes (80%, 60%, then 40%) over a 14-week period. Participants were blinded to the program settings. Participants then received their preferred program for further evaluation at 26 and 52 weeks after activation. Outcome measures included back pain score (visual analogue scale [VAS]), Brief Pain Inventory (BPI), EuroQol 5-Dimension 5-Level (EQ-5D-5L), 36-Item Short Form Health Survey (SF-36), treatment satisfaction, and clinician global impression of change (CGIC).ResultsAt 52 weeks (n = 24), the responder rate (≥50% pain relief) was 65.6%, and the high-responder rate (≥80% pain relief) was 56.5%. The mean change from baseline in pain VAS was -43.94 mm (95% CI -57.89, -30.00; p < 0.001) and mean pain relief was 64.69% ± 39.43%. BPI and SF-36 scores remained significantly improved (p ≤ 0.001). EQ-5D-5L index and EuroQoL-VAS further improved, and 87.0% of participants met the minimum clinically important difference for the EQ-5D-5L index. Treatment satisfaction was 83%, and 91% of participants had a CGIC rating of "much improved" or above. No serious study-related adverse events were reported.ConclusionsThe 12-month trial results show sustained improvements in pain, quality of life, and health-related outcomes. This novel subperception dorsal horn dendrite SCS approach seems a safe and promising treatment option for patients with chronic neuropathic LBP. The open-source availability of this waveform on commercial SCS platforms allows widespread patient access. Further evaluation seems warranted.Clinical Trial RegistrationThe Clinicaltrials.gov registration number for the study is ACTRN12618000647235 (anzctr.org.au).Copyright © 2024 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.

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