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.
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