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Updated: Jul 2, 2026
Treating Low Back Pain in Failed Back Surgery Patients with Multicolumn-lead Spinal Cord Stimulation
Published on: June 26, 2018
Complication Rates of Spinal Cord Stimulation: A Systematic Review and Meta-Analysis
Nicholas Giulio Raccagni1, Marco Dotti2, Behnaz Goudarzi1
1Department of Medicine and Surgery, Università degli Studi di Milano-Bicocca, Via Cadore 48, 20900 Monza, Italy.
Objectives:
Spinal cord stimulation (SCS) is an established therapy for refractory chronic neuropathic pain; however, reported complication rates vary substantially and are typically derived from heterogeneous patient-level measures. Event-based synthesis, which accounts for recurrent adverse events (AEs) and differential follow-up duration, remains limited. We conducted a systematic review and meta-analysis to quantify complication rates associated with SCS.
Materials And Methods:
PubMed, Embase, Scopus, Web of Science, and the Cochrane Library were systematically searched for randomized trials, cohort, or registry-based studies reporting explicit numerical AE counts in adults undergoing SCS implantation. Primary outcomes were AE burden per patient and AE incidence rate per 100 patient years (PY). Secondary outcomes included lead migration, infection, revision procedures, explantations, and serious AEs (SAEs). Tertiary outcomes captured patient-level risks of experiencing ≥1 AE or ≥1 SAE.
Results:
A total of 33 studies comprising 3445 patients and 1119 AEs were included. The pooled AE burden was 0.35 events per patient (95% CI, 0.28-0.43), and the incidence rate was 34.5 events per 100 PY (95% CI, 24.7-48.3), with substantial heterogeneity. Lead migration occurred more frequently than infection (7.05 vs 2.82 events per 100 PY), and revision procedures exceeded explantations (6.31 vs 2.93 events per 100 PY). At the patient level, 24% experienced ≥1 AE and 3% experienced ≥1 SAE. Lower incidence rates were observed in retrospective studies, paddle lead cohorts, studies evaluating differential target multiplexed stimulation, and in studies with longer follow-up, more recent publication years, and larger sample sizes.
Conclusions:
SCS is associated with a measurable burden of complications that accrues over time and is unevenly distributed across patients. Variability across studies likely reflects differences in study design, follow-up duration, and reporting practices. Standardized AE definitions and reporting frameworks are needed to improve comparability across SCS studies.
