Single-Area Versus Multiple-Area Passive Recharge Burst During Spinal Cord Stimulator Trials: An Independent Prospective Randomized, Double-Blind Study

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Abstract

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 multi-area pain. This study examined single vs. multi-area passive recharge burst therapy in a neurostimulation naive population during percutaneous SCS trial. METHODS: This study was 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 were randomized to receive either single area burst therapy or two-area burst therapy-with both subject and physician blinding. Programming was adjusted mid-trial based on optimizing 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 planned 30 patients completed follow up. The average VAS pain score was 70.2 at baseline and 22.2 at the end of the trial. The average pain relief at mid-trial was 53%, which improved to 67% at the end of the trial with conversion to multi-area programming. There was an overall 87% trial to permanent conversion ratio, with 83% of the patients ending trial on multi-area burst therapy. Analysis of PROMIS-29 scores demonstrates the most significant improvements in pain intensity, pain interference, physical function, sleep, and anxiety. CONCLUSION: Multi-area passive recharge burst has demonstrated a high rate of trial success with significant pain and symptom relief. In addition, there were improvements in pain intensity, pain interference, physical function, sleep, and anxiety. Multi-area passive recharge burst therapy is a viable option to be utilized during a trial to improve patient outcomes and optimize trial success.

Abstract as published, via PubMed.