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Title: Spinal Cord Stimulation Modalities Used In Combination For Chronic Pain In A Prospective, Randomized Controlled Trial (Combo)
e-poster Number: INSIM6
Category: Pain
Author Name: Mark Wallace
Institute: University of California, San Diego
Co-Author Name: COMBO Clinical Study Group
Abstract :
Background: Spinal Cord Stimulation (SCS) devices that enable fine-tuning of parameters or waveforms offer potential to address variability among chronic pain patients. We endeavored to investigate outcomes associated with neurostimulation modalities used in combination as compared with conventional SCS settings alone in a prospective, randomized controlled trial.
Methods/Materials: COMBO is a prospective, multicenter, randomized controlled trial (NCT03689920). The primary endpoint was proportion of subjects permanently implanted with an SCS system capable of multiple neurostimulation modalities (Spectra WaveWriter, Boston Scientific), demonstrating 50% or greater reduction in average overall pain intensity at 3 months post-randomization (versus Baseline), with no increase in baseline average daily opioid medications used to treat pain. Additional endpoints include assessment of quality of life, disability and adverse events.
Results: The study met its primary endpoint based on a pre-specified cohort of 89 randomized subjects (p<0.001). An interim analysis of 41 subjects using Combination Therapy (paresthesia-based SCS with a customized field shape algorithm) were able to achieve better clinical outcomes than those randomized to using paresthesia alone (monotherapy, 48 subjects) at 3-months post-randomization compared with Baseline as demonstrated by the following: a higher responder rate with no increase in opioid medications (88%), significant improvement in disability (? 25.6 points in ODI score versus subjects using monotherapy), and a very high level of patient satisfaction (90% subjects report very/much improved as measured by Patient Global Impression of Change, PGIC).
Discussion/Conclusion: Outcomes of this prospective RCT provides Level 1 evidence regarding an SCS system capable of neurostimulation modalities used in combination.
