Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States.

Abstract

Background: Fast-acting Sub-perception Therapy (FAST) is a novel spinal cord stimulation (SCS) modality delivering paresthesia-free pain relief. Our study evaluated the longer-term, real-world impact of FAST on chronic pain.

Research design and methods: As part of a multicenter, real-world, consecutive case series, we retrospectively identified patients who used FAST-SCS and analyzed their data. The numerical rating scale (NRS) was used to evaluate the overall pain.

Results: Data from 315 patients were analyzed at baseline and their last available follow-up (median 6.8 months after SCS implantation). At the time of the analysis, 12-, 18-, and 24-month data were available for 112, 86, and 50 patients, respectively. At the last follow-up, NRS pain score was reduced by 5.5 ± 2.5 compared to baseline (from 7.8 ± 1.7 to 2.3 ± 2.0; p < 0.0001). Interim long-term analysis showed that results were sustained for up to 2 years, with 64% of patients reporting a minimal overall pain score (NRS ≤2/10).

Conclusion: This ongoing, real-world, multicenter study showed that FAST-SCS achieved significant paresthesia-free pain relief, while long-term interim analysis suggests that outcomes could be sustained for up to 2 years. Our data provide preliminary insights into the potential utility of this low-frequency sub-perception SCS paradigm using a biphasic active recharge pulse shape.

Trial registration: ClinicalTrials.gov (CT.gov identifier: NCT01550575).