Abstract #1399039: Treatment of Painful Diabetic Neuropathy: 10 kHz SCS Provides Durable Pain Relief and Sensory Improvements

Of the 37 million Americans who have diabetes, up to 25% experience painful diabetic neuropathy (PDN). While conventional medical management (CMM), which includes pharmacotherapies, can be ineffective for many patients, high-frequency (10 kHz) spinal cord stimulation (SCS) has been shown provide substantial symptom relief PDN. Here we report durability of outcomes 24 months (24M) 10 kHz SCS treatment We conducted a prospective, multicenter, randomized, controlled trial (RCT) evaluate in PDN patients. Key inclusion criteria were: symptoms ≥12M refractory medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), and hemoglobin A1c ≤10%. Patients (n=216) were randomized 1:1 plus CMM or alone, with optional group crossover at 6M. experienced average 76% 6M, while patients receiving alone increase 2%. After 93% eligible crossed over SCS, no CMM. At 24M, durable relief, 80%. Reductions pain-associated sleep disturbance interference mood daily activities consistent relief. provided reductions vs. 65% decrease 67% activities. Clinician-assessed sensory function improvements feet legs observed SCS. 59% only 9% alone. Sensory as had 24M. In total, 154 received an implant. There eight (5.2%) study-related infections (n=3 resolved; n=5 (3.2%) explanted), is within range reported across all patient populations (2.5-10%). The results this RCT demonstrate that provides effects on health-related quality life acceptable safety, now through 24-month follow-up. highlight disease-modifying potential