ESRA19-0159 A prospective global registry of real-world outcomes using spinal cord stimulation systems for chronic pain. (30th August 2019)

• Record Type: Journal Article
• Authors: Love-Jones, S; Thomson, S; Rauck, R; Group, RELIEFStudy; Woon, R; Jain, R
• Is Part Of: Regional anesthesia and pain medicine. Volume 44(2019)Supplement 1
• Page Start: A77
• Page End: A77
• Publication Date: 2019-08-30
• Subjects: Conduction anesthesia -- Periodicals; Pain medicine -- Periodicals; 617.964
• DOI: 10.1136/rapm-2019-ESRAABS2019.67
• Languages: English
• ISSNs: 1098-7339

Abstract

Abstract : Background and aims: Real world evidence (RWE) derived from clinical registries via application of advanced data analytics represents a potentially important aspect of the on-going rational assessment and future development of commercially-available spinal cord stimulation (SCS) devices. We present here a prospective global registry designed to evaluate long-term, clinical application of neurostimulation therapy for pain. Methods: This is a prospective, multicenter global registry (RELIEF Registry, Boston Scientific) that assesses up to 1700 participants at up to 80 centers (ClinicalTrials.gov Identifier: NCT01719055 ). These assessments will encompass pain relief, satisfaction, quality of life, safety, and other aspects associated with the real-world clinical use of SCS. Eligible study participants are trialed for 'on label' use only with a commercially-approved SCS system (Boston Scientific). All permanently-implanted subjects are followed out to 36-months. Results: A total of 1, 151 subjects have been assessed out to 3-years post-implantation. Patient satisfaction (PGIC) assessment determined that 88% of registry participants reported overall therapeutic improvement within the span of this 3-year duration. In addition, a low incidence of explants due to device-related complications of 7.9% was determined with only 2.4% indicating that this was due to inadequate pain relief (% explant per year: 3.6%). Conclusions: Real-world evidence derived from large patient registries is needed to assess patient quality of life and device longevity when using SCS to treat chronic pain. the 3-year results of this prospective, real-world registry demonstrate a low percent explant rate per year and a high percentage of patients reporting therapeutic improvement when using an SCS device to treat their chronic pain.