Background: Treating chronic pain using sub-perception Spinal Cord Stimulation (SCS) does not elicit paresthesia but is associated with long analgesic ‘wash-in’ (i.e. duration until maximum pain relief) and prolonged assessment of therapy. We describe the attainment of clinically meaningful and rapid-onset analgesic outcomes using a novel sub-perception SCS approach. Methods: This observational case-series evaluated patients implanted with an SCS device for chronic pain, who underwent re-programming utilizing a new methodology in which paresthesia was used to guide sub-perception stimulation field targeting at specific parameters including charge-balanced symmetrical pulses at 90 Hz (termed Fast-Acting Sub-Perception Therapy, FAST). Pain scores (NRS) were collected as reported per standard-of-care from patient charts. Results: Mean overall pain score at baseline was 8.4 ± 0.2 (n = 41). After activation of FAST, a 7.1-point reduction in overall pain score was (1.3 ± 0.2, p < 0.0001) reported within 11.2 ± 1.9 minutes (n = 34). This decrease in pain score was sustained out to 3-month (1.6 ± 0.3, n = 26) and 6-month follow-up (1.7 ± 0.4, n = 18). At last follow up (mean = 223 ± 132 days), a pain score of 1.6 ± 0.3, n = 30 was determined. Conclusions: After FAST implementation, a profound analgesic response, requiring substantially less energy than conventional sub-perception methodologies, was observed. This rapid analgesic onset achieved with the novel FAST technique suggests the potential for an alternative mechanism of action(s) of sub-perception SCS.

Given the range of subjective experiences reported by patients with chronic pain, Spinal Cord Stimulation (SCS) systems designed for tailored delivery of analgesic therapy may help improve treatmen...

Background/Objectives: Evidence on the effectiveness of spinal cord stimulation using fast-acting subperception therapy (FAST-SCS) in patients with persistent spinal pain syndrome (PSPS) remains limited. We evaluated clinical outcomes of FAST-SCS in patients with PSPS types 1 (i.e., non-surgical back pain) and 2 (i.e., failed back surgery syndrome). Methods: Our global, multicenter, retrospective, observational chart review included all consecutive adults with chronic low back and/or leg pain due to PSPS who received SCS with a multimodal device and reported using FAST-SCS at their latest follow-up. Available data from the patients’ medical files, documented by site personnel per their standard of care, were collected and analyzed. Pain intensity was assessed using the numerical rating scale (NRS); percent pain relief (PPR) was recorded where available. Main outcomes included changes in overall pain (NRS) compared to baseline, proportion of patients with ≥50% reduction in overall pain (NRS), proportion of patients with minimal pain (NRS ≤ 2), and high responder rates (PPR ≥ 80%). Data was analyzed for all PSPS patients at the last follow-up, with preliminary analysis of patients who completed 3-year assessments. Results in PSPS type 1 and 2 patients at the last follow-up are also presented. Results: In total, 424 patients (mean age 61.6 ± 13.5 years; 57% female; 61% PSPS type 2) were included. Mean baseline NRS was 8.0 ± 1.4. At the last follow-up (mean 1.6 ± 1.5 years post-implantation), NRS decreased by 5.3 points to 2.7 ± 2.3 (p < 0.0001), 77% of patients achieved ≥50% reduction in pain, 56% reported minimal pain, and 62% were high responders. Similar improvements were observed in the preliminary analysis of 104 PSPS patients who completed the 3-year follow-up, with ≥5-point reduction in the NRS, 77% responder rate, 60% patients with minimal pain, and 70% high responders. The analysis of PSPS type 1 and 2 populations, adjusted for baseline NRS and follow-up durations, showed comparable outcomes. Conclusions: In this global, observational, “as-treated” cohort, favorable real-world outcomes were observed in PSPS patients using FAST-SCS, supporting its use as an effective treatment option in chronic spinal pain management.