42. Prospective trial investigating interactable nonsurgical neuropathic lower lumbar pain (PSPS type1) using mixed waveform SCS therapy: 2 years clinical data

Abstract

Background: Although SCS is a successful treatment for PSPS type 1, the evidence is evolving and is limited by long term data and quality of life outcomes. There is a need to identify underlying pathology in this cohort that may contribute to failure of therapy. The primary objective of the study was to investigate the clinical response following neurostimulation in patients with lumbar PSPS type 1. The secondary objective of the study was to investigate the effect on functionality, quality of life, sleep index and adverse events in the study population. The study also aimed to analyse the failure/explant rate and associated pertinent MRI factors. Method(s): Patients with intractable neuropathic pain PSPS type 1 (n=30) were recruited (2019-22) in a single tertiary neuromodulation centre to undergo SCS (BSC Alpha wavewriter, dual 16 contact infinion leads) direct to implant with anatomical placement at T9-T10. All patients underwent mandatory 1000Hz frequency stimulation until the primary end point (12 weeks) followed by real world waveforms as deemed suitable with patient and clinician compliance. NRS and data from self-reported questionnaires (Oswestry Disability Index (ODI), Pain and Sleep Questionnaire (PSQ), Patient Global Impression of Change), and EQ-5D-5L were collected pre-implant and at 4 weeks, 12 weeks, 6 months, 12 months and 24 months post-implant. All implanted patients underwent MRI imaging preoperatively and images were reviewed by an independent radiologist for all explants/failures to identify any contributing factors. Result(s): Average NRS for back and leg improvement at 4 weeks (n=28) -49% and -54% vs. baseline; at 12 weeks (n=27) -43% and -55% vs. baseline; at 12 weeks (n=27), -43% and -55% vs. baseline; at 6 months (n=22) -50% and -61% vs. baseline; at 12 months (n=19), -46% and -52% vs. baseline; at 24 month (n=13),-50% and -51% vs. baseline. ODI scores at 12 months 42.5+/-23.52 (-23% vs. baseline), and 24 months 38.93+/-24.12 (-29% vs. baseline) were reported. Detailed analysis of explants including MRI imaging will be presented. Conclusion(s): Although this long-term follow-up supports the clinical benefit of SCS up to 50% at 24 months in PSPS type1, there remains a need to identify patients that are poor responders in this cohort. This can potentially help in improving patient selection criteria within this group of population. Copyright © 2025