A Pilot Study Comparing Algorithmic Adaptive Conventional Stimulation with High-Dose Stimulation in Chronic Pain Patients

Abstract

Spinal cord stimulation is an effective method of treatment for chronic pain. We previously showed that programming using accelerometry was advantageous for paresthesia-based stimulation. However, programming can be labor intensive. Here we focus on standardized programming for both accelerometer-based paresthesia-induced programming (termed "shuffle") and high-dose (HD) subthreshold programming with stimulation delivered over the T9-10 interspace. In this prospective cross-over study, patients received 4 weeks of shuffle programming and 4 weeks of HD programming in a randomized order. In both intervals, contacts overlying T9-10 were programmed. Pain scales with measurements of activity and sleep were collected at the end of each study arm and compared with preoperative baseline scores. Twelve patients were enrolled, with 10 patients completing this study. Compared with baseline, during the HD study period, significant improvements were seen in worst pain of week (P= 0.03) and current pain (P= 0.04) as rated on Numeric Rating Scale scores and walking on the Activity Test (P= 0.012). No difference was seen from baseline compared with shuffle stimulation or in shuffle stimulation compared with HD stimulation. In this pilot study, we demonstrated that HD stimulation at T9-10 is superior to algorithmic programming of paresthesia-based stimulation. These results compared with our previous work with shuffle suggest that paresthesia-based stimulation may necessitate stimulation of additional contact locations and additional programming to optimize. This algorithmic programming of paresthesia-based stimulation continues to warrant exploration.