ObjectiveThe aim of this study was to investigate the long-term efficacy and safety of paresthesia-free high-frequency spinal cord stimulation (HF10 SCS) for the treatment of chronic, intractable pain of the low back and legs.DesignProspective, multicenter, observational study.MethodPatients with significant chronic low back pain underwent implantation of a spinal cord stimulator capable of HF10 SCS. Patients' pain ratings, disability, sleep disturbances, opioid use, satisfaction, and adverse events were assessed for 24 months.ResultsAfter a trial period, 88% (72 of 82) of patients reported a significant improvement in pain scores and underwent the permanent implantation of the system. Ninety percent (65 of 72) of patients attended a 24-month follow-up visit. Mean back pain was reduced from 8.4 ± 0.1 at baseline to 3.3 ± 0.3 at 24 months (P < 0.001), and mean leg pain from 5.4 ± 0.4 to 2.3 ± 0.3 (P < 0.001). Concomitantly to the pain relief, there were significant decreases in opioid use, Oswestry Disability Index score, and sleep disturbances. Patients' satisfaction and recommendation ratings were high. Adverse Events were similar in type and frequency to those observed with traditional SCS systems.ConclusionsIn patients with chronic low back pain, HF10 SCS resulted in clinically significant and sustained back and leg pain relief, functional and sleep improvements, opioid use reduction, and high patient satisfaction. These results support the long-term safety and sustained efficacy of HF10 SCS.

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ObjectivesClinical trials of spinal cord stimulation (SCS) have largely focused on conversion from trial to permanent SCS and the first years after implant. This study evaluates the association of type of SCS and patient characteristics with longer‐term therapy‐related explants.Materials and MethodsImplanting centers in three European countries conducted a retrospective chart review of SCS systems implanted from 2010 to 2013. Ethics approval or waiver was obtained, and informed consent was not required. The chart review recorded implants, follow‐up visits, and date and reasons for any explants through mid‐2016. Results are presented using Cox regression to determine factors associated with explant for inadequate pain relief.ResultsFour implanting centers in three countries evaluated 955 implants, with 8720 visits over 2259 years of follow‐up. Median age was 53 years; 558 (58%) were female. Explant rate was 7.9% per year. Over half (94 of 180) of explants were for inadequate pain relief, including 32/462 (6.9%) of implants with conventional nonrechargeable SCS, 37/329 (11.2%) with conventional rechargeable and 22/155 (14.2%) with high‐frequency (10 kHz) rechargeable SCS. A higher explant rate was found in univariate regression for conventional rechargeable (HR 1.98, p = 0.005) and high‐frequency stimulation (HR 1.79, p = 0.035) than nonrechargeable SCS. After covariate adjustment, the elevated explant rate persisted for conventional rechargeable SCS (HR 1.95, p = 0.011), but was not significant for high‐frequency stimulation (HR 1.71, p = 0.069).ConclusionsThis international, real‐world study found higher explant rates for conventional rechargeable and high‐frequency SCS than nonrechargeable systems. The increased rate for conventional rechargeable stimulation persisted after covariate adjustment.