BURST(able): A Retrospective, Multicenter Study Examining the Impact of Spinal Cord Stimulation with Burst on Pain and Opioid Consumption in the Setting of Salvage Treatment and “Upgrade”

Abstract

Background Loss of efficacy (LOE) is a well-known phenomenon associated with spinal cord stimulation (SCS) and is the leading cause of explant. Although recent advances in neuromodulation have resulted in a decreased incidence of LOE, it still occurs. Intuition suggests that when LOE ensues, switching to a SCS therapy/platform could potentially be a viable clinical option; however, there are no data presently available to validate this theory. Objectives The primary objective was to evaluate the efficacy of SCS rotation with DeRidder Burst on reversing LOE. A subobjective was to evaluate the hypothesis that the body will treat a novel waveform as a different therapy when introduced for the first time, regardless of the setting. Study design Multicenter, retrospective. Setting Private practice. Methods A total of 307 patients with ongoing SCS had a de novo conversion to DeRidder Burst via surgical revision or software upgrade. Each cohort was split into 2 additional arms/subcohorts: those who were failing their SCS (salvage) versus those who were reporting success with their SCS system but were looking for increased pain relief (upgrade). This study was physician-directed and not commercially funded. Results There were statistically significant reductions in Numeric Rating Scale, percent pain relief in both surgical revision and software upgrade arms. A statistical reduction in opioid dosing was seen in the overall population and the salvage group. Larger reductions in pain/opioid consumption were observed in the surgically revised group when the revision was performed earlier. Subgroup analysis showed both salvage and upgrade groups restored treatment efficacy irrespective of time or the previous frequency/waveform. Limitations The retrospective nature of the study and the inability to eliminate potential confounding variables when evaluating the use of opioids in the study population. Conclusions LOE is an unfortunate occurrence with few evidence-based solutions presently available to reverse it. Our findings suggest that implementing D-Burst stimulation may be an effective option for treating LOE, as well as potentially reducing opioid consumption, regardless of the prior SCS system.