Results

Demographics

57 subjects enrolled at 12 US sites from November 2020 to June 2021. Patient demographics are shown in Table 1. Post-laminectomy pain/PSPS-T2 was the main etiology (91.2%). 49 subjects underwent trial, 35 were implanted, and 27 completed the 12-Month visit.

Overall, Back, and Leg Pain Scores

The primary objective analysis demonstrated a mean reduction (standard deviation) of 3.9cm (2.5) in overall pain, as measured by Visual Analog Scale (VAS), from baseline at the 3-month follow-up (Figure 1). Changes in overall pain were clinically sustained at 3- , 6-, and 12-months with 50.4%, 52.4%, 56.1% improvement, respectively (Figure 1).

Activity Goals

88.9% of subjects met one or more of their specified activity goals set at baseline by the 12-month visit (Figure 3, Table 2). Activity goals set at baseline fell into 4 of the 5 categories set for analysis (Table 2). Most subjects set baseline goals in the basic movement and sports/higher activity categories (Figure 3). We observed that 94% of responder subjects (≥50% pain relief) at 12-months achieved a goal set at baseline. Interestingly, we observed that 82% of non-responder subjects (did not achieve ≥50% pain relief) at 12-months were still able to achieve a goal set at baseline.

Conclusions