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

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;  < 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).