Synopsis
We endeavored to investigate outcomes associated with use of multiple neurostimulation modalities as compared with conventional SCS settings alone in a prospective, randomized controlled trial. The primary endpoint was proportion of subjects permanently implanted with an SCS system capable of multiple neurostimulation modalities demonstrating 50% or greater reduction in average overall pain intensity at 3-months post-randomization. The study met its primary endpoint based on a pre-specified cohort of 89 randomized subjects (p<0.001). The results provide further support for the advantages of using neuromodulation systems capable of patient-specific stimulation options that enable highly customized therapy for treatment of chronic pain.
Disclosures
- Drs. Wallace, North, Washabaugh, Lee, Phillips, and Trainor have consulting agreements with Boston Scientific.
- Lilly Chen and Roshini Jain are employees of Boston Scientific.
Author(s):
- Mark Wallace, MD, University of California, San Diego
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| Abstract - NPC2021 Wallace COMBO 2021 | Download Abstract |
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Long-Term Outcomes Using an SCS System Capable of Combination Therapy: A Randomized Controlled Trial (COMBO)
Synopsis
We endeavored to investigate outcomes associated with use of multiple neurostimulation modalities as compared with conventional SCS settings alone in a prospective, randomized controlled trial. The primary endpoint was proportion of subjects permanently implanted with an SCS system capable of multiple neurostimulation modalities demonstrating 50% or greater reduction in average overall pain intensity at 3-months post-randomization. The study met its primary endpoint based on a pre-specified cohort of 89 randomized subjects (pxtagstartz0.001). The results provide further support for the advantages of using neuromodulation systems capable of patient-specific stimulation options that enable highly customized therapy for treatment of chronic pain.