Abstract No. 267 Treatment of Painful Diabetic Neuropathy: 10-kHz Spinal Cord Stimulation Provides Durable Pain Relief and Sensory Function Improvements

The objective of this study was to evaluate the long-term safety and effectiveness of high-frequency (10 kHz) spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN). This randomized, controlled trial (RCT) evaluated 10 kHz SCS in PDN patients with 24-month (24M) follow-up. Key study inclusion criteria were PDN symptoms ≥12M refractory to medications, lower limb pain intensity ≥5 cm (0-10 cm visual analog scale [VAS]), and hemoglobin A1c ≤10%. Patients (n=216) were randomized 1:1 to 10 kHz SCS plus conventional medical management (CMM) or CMM alone, with optional treatment group crossover at 6M. At 6M, patients randomized to 10 kHz SCS experienced significantly greater pain relief than with CMM alone (10-cm VAS, pain relief of 76% for 10 kHz SCS vs. pain increase of 2% for CMM alone; p< 0.001). After 6M, 93% of eligible CMM patients crossed over to 10 kHz SCS, while no 10 kHz SCS patients crossed over to CMM. When evaluating all patients who received 10 kHz SCS at 24M postimplantation, the average pain relief was 80% (p< 0.001 vs. preimplantation), and the pain responder rate (proportion of patients with ≥50% pain relief) was 90%. Reductions in pain interference with sleep (PSQ-3 questionnaire) were consistent with pain relief. At 6M, 10 kHz SCS provided significant reductions vs. CMM (p< 0.001), and at 24M, patients receiving 10 kHz SCS experienced a 66% decrease in pain interference with sleep (p< 0.001 vs. preimplantation). Protective sensation in the feet was assessed via monofilament sensory function testing and associated risk of foot ulceration per American Diabetes Association guidelines. At 6M, the number of patients with low risk of foot ulceration improved by 90% for patients randomized to 10 kHz SCS and reduced by 11% for patients randomized to CMM alone (p< 0.001). When evaluating all patients who received 10 kHz SCS, the number of patients with low risk of foot ulceration improved by 103% at 24M postimplantation (p=0.006). There were no device explants due to lack of efficacy. There were eight (5.2%) study-related infections (n=3 resolved; n=5 (3.2%) explanted), which is within the range reported for SCS in non-diabetes populations (2.5-10%). The results demonstrate that 10 kHz SCS provides durable pain relief with acceptable safety. The sensory improvements observed via protective sensation evaluation highlight the unique disease-modifying potential of 10 kHz SCS for PDN, and future work will evaluate the effectiveness of 10 kHz SCS for reducing diabetic foot complications and associated healthcare costs.