Introduction: Intermittent passive recharge burst therapy is an established therapy to optimize pain relief and mitigate the problems associated with battery life and charging burden. Newer programming parameters have been explored to provide patients with this targeted burst therapy in multiple areas. These areas are programmed separately to optimize pain relief for a complex patient population and those with multiarea pain. This study examined single vs. multi-area passive recharge burst therapy in a naive population during percutaneous SCS trial.
Methods: This study is performed at a single institution by a single trialing physician. Candidates for the study were enrolled on a consecutive basis for any painful condition in the management of chronic, intractable pain of the back, trunk and limbs. Subjects are randomized in a double-blind fashion to start with either single area burst therapy or two-area burst therapy. Programming can be adjusted mid-trial based on pain relief and could include up to four-area burst. Patient outcomes included VAS, percent pain relief, proceeding to implant, and Promis-29 scores.
Results: All of the planned 30 patients have been enrolled and will be presented. This is the interim analysis of the first 20 patients. The average VAS pain score was 69.4 at baseline and 26.5 at the end of the trial (Figure 1). The average pain relief at mid trial was 52% which improved to 64% at the end of the trial with conversion to multi-area programming. There was an overall 87% trial to permanent conversion ratio, with the majority of patients on the two-area burst therapy. Analysis of Promis-29 scores demonstrates the most significant improvements in pain intensity, pain interference, physical function, and anxiety (FIGURE 2).
Conclusion: This real world, physician run prospective double-blind analysis has demonstrated a high trial to perm ratio for the passive recharge burst therapy, but has also demonstrated improved pain relief and conversion utilizing multi-area burst. In addition, there were improvements in pain intensity, pain interference, physical function, and anxiety. Multi-area passive recharge burst therapy is a viable option to be utilized during a trial to improve patient outcomes.
