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REAL WORLD EVIDENCE OF CLINICAL OUTCOMES OF MULTIMODAL SPINAL CORD STIMULATION: A PROSPECTIVE GLOBAL REGISTRY STUDY
ESRA Academy. Mekel-Bobrov N. Sep 8, 2016; 138425
Topic: NEUROPATHIC PAIN
Disclosure(s): Dr. Nitzan Mekel-Bobrov is a full time employee of Boston Scientific.
Dr. NItzan Mekel-Bobrov
Dr. NItzan Mekel-Bobrov

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Abstract
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Background and Aims:

Different treatment modalities in Spinal Cord Stimulation (SCS) are now available including standard rate, 1K, burst, anode intensification, 10K, Multiple Independent Current Control (MICC), etc. On the other hand, identification and analysis of clinically-relevant patient sub-populations using these different modalities, via mining large datasets of real word evidence (RWE) and implementation of advanced analytics, have not yet been conducted. We report here the largest SCS study of its kind designed to investigate real-world, multimodal SCS.

Methods:

This is a prospective, multi-center, global registry study (RELIEF Registry, Boston Scientific) enrolling up to 4800 subjects at up to 150 centers. All subjects undergo a trial for pain with a commercially-approved neurostimulator and followed up to 36-months.  Previously collected utilization data from 800 patients using a system capable of multiple programs/waveforms was collected.

Results:

Analyzed subjects used several programs/waveforms from 0-30 days post-implant (10-11 programs) but stabilize by 6 months post-implant (2-3 programs). Most subjects utilized the standard SCS waveform (62.6%) compared to others (1k, anode intensification, burst). Seventy-two percent of subjects utilized multimodal SCS versus single mode (28%). Of these, approximately 90% of subjects use at least 2 modes (~10% use 3 or more) with most using a combination of 1 kilohertz and standard rate programs (29%).

Conclusions:

This study collects and analyzes a large dataset of RWE. Subjects have so far been found to use multiple modalities/waveforms long-term, using a variety of options at different times each day. This initial observation underscores the clinical-relevance of a single device capable of multimodal SCS.

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