Fast-Acting Subperception Spinal Cord Stimulation for Persistent Spinal Pain Syndromes: Real-World Outcomes for up to 3 Years in an "As-Treated" Cohort from a Global Observational Study.

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.