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Title: Outcomes Using An SCS Device Capable Of Delivering Combination Therapy And Advanced Waveforms/Field Shapes
e-poster Number: INSIM4
Category: Pain
Author Name: Clark S Metzger
Institute: NeuroMicroSpine
Co-Author Name: MB Hammond, Stephen Pyles, Ed Washabaugh, Romanth Waghmarae
Abstract :
Background: Developing all-in-one spinal cord stimulation (SCS) systems with capability for multiple neurostimulation paradigms likely will empower patients to identify the best treatment approach(es) suitable for their needs. Here, we provide real-world outcomes in patients who used an SCS system designed to combine availability of multiple waveforms, delivered either sequentially and simultaneously, with an algorithm designed to enable highly manipulatable control of field shape.
Methods: This is a consecutive, multi-center case-series based on retrospective chart review (Clinicaltrials.gov identifier: NCT01550575). Patients were implanted with an SCS system (Precision Spectra WaveWriter, Boston Scientific) capable of combination therapy (sequential or simultaneous), multiple waveforms and advanced field shapes for low back and/or leg pain. Data collection included: 1) Baseline characteristics: demographics, pain diagnosis 2) procedural information: lead configuration, programming parameters; and 3) pre- and post- implant numerical rating scale pain intensities (0-10 NRS).
Results A statistically significant improvement in overall targeted pain scores at last follow-up was reported (Baseline NRS: 7.2; mean last follow-up [208±200 days] NRS: 2.4; p<0.0001). Twenty-three percent of patients (95 of 420) indicated being free of pain at last follow-up. At 3-months post-implant (n=256), a mean 5.1±2.4 point improvement (p<0.0001) in overall pain was reported. This reduction was similarly reported in patients at 12-month (n=122) and 24-month timepoints (n=26).
Discussion: These results support the notion that SCS patients do benefit when provided with a single device delivers multiple waveform types, in a sequential or simultaneous manner, and in combination with capability for highly specific targeting of the neurostimulation field.