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- W3172783126 abstract "Objective: To document the safety and effectiveness of 10kHz high frequency SCS (HF-SCS) in treatment of chronic intractable pain from peripheral polyneuropathy (PPN). Background: Current treatment options for neuropathic pain are primarily pharmacological with limited effectiveness and sometimes intolerable side effects1. Based on documented long-term pain relief seen in previous studies, we hypothesized that paresthesia-independent, 10 kHz HF-SCS may provide effective pain relief for neuropathic pain2,3. Design/Methods: Subjects with chronic, intractable pain of ≥5 cm (on a 0–10 cm visual analog scale) of the upper/lower limb from PPN were enrolled in a prospective, multi-center study following IRB approval. Subjects with successful trial stimulation were implanted with a Senza system (Nevro Corp., Redwood City, CA) with two epidural leads spanning C2–C6 or T8–T11 vertebral bodies for upper limb pain and lower limb pain, respectively. Interim 12-month results are presented as mean±95% CI. Results: Twenty-two of the 26 subjects (84.6%) trialed had a successful trial and 18 received a permanent implant . Five procedure related adverse events or serious adverse events were reported. In addition to improvements in pain and disability (Table 1), neurological assessment demonstrated either sensory, motor or reflex improvements in 12, and 14 subjects at end of trial and 3 months, respectively. Conclusions: 10 kHz HF-SCS resulted in long-term clinically meaningful improvements with concomitant improvements in subjects’ neurological status. Disclosure: Dr. Galan has nothing to disclose. Dr. Chang has nothing to disclose. Dr. Scowcroft has nothing to disclose. Dr. Li has nothing to disclose. Dr. Saats has nothing to disclose. Dr. Subbaroyan has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Nevro Corp. Dr. Subbaroyan holds stock and/or stock options in Nevro Corp which sponsored research in which Dr. Subbaroyan was involved as an investigator. Dr. Subbaroyan holds stock and/or stock options in Nevro Corp." @default.
- W3172783126 created "2021-06-22" @default.
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- W3172783126 date "2019-04-09" @default.
- W3172783126 modified "2023-09-23" @default.
- W3172783126 title "A Prospective Clinical Trial to Assess High Frequency Spinal Cord Stimulation (HF-SCS) at 10 kHz in the Treatment of Chronic Intractable Pain from Peripheral Polyneuropathy (P2.6-065)" @default.
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