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Papers of the Week

Papers: 21 Jan 2023 - 3 Feb 2023

2023 Jan 24

Pain Manag

Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.


Rauck RL, Loudermilk E, Thomson SJ, Paz-Solis J F, Bojrab L, Noles J, Vesper J, Atallah J, Roth D, Hegarty J, Prud'Homme M, Phillips GM, Smith SG, Ibrahim M, Willoughby CD, Obray JB, Gupta M, Paez J, Berg AP, Harrison NJ, et al.
Pain Manag. 2023 Jan 24.
PMID: 36691862.


The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. : NCT01719055 (ClinicalTrials.gov).