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

Objective:
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 to provide substantial symptom relief for PDN. Here we report durability of outcomes to 24 months (24M) months for 10 kHz SCS treatment of PDN.

Methods:
We conducted a prospective, multicenter, randomized, controlled trial (RCT) to evaluate 10 kHz SCS in PDN patients. Key inclusion criteria were: PDN symptoms ≥12M refractory to medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), and hemoglobin A1c ≤10%. Patients (n=216) were randomized 1:1 to 10 kHz SCS plus CMM or CMM alone, with optional treatment group crossover at 6M.

Results:
Patients randomized to 10 kHz SCS experienced average pain relief of 76% at 6M, while patients receiving CMM alone experienced average pain increase of 2%. After 6M, 93% of eligible CMM patients crossed over to 10 kHz SCS, while no 10 kHz SCS patients crossed over to CMM. At 24M, patients receiving 10 kHz SCS experienced durable pain relief, with average pain relief of 80%.

Reductions in pain-associated sleep disturbance and pain interference with mood and daily activities were consistent with pain relief. At 6M, 10 kHz SCS provided substantial reductions vs. CMM. At 24M, patients receiving 10 kHz SCS experienced a 65% decrease in pain-associated sleep disturbance and a 67% decrease in pain interference with mood and daily activities.

Clinician-assessed sensory function improvements in the feet and legs were observed with 10 kHz SCS. At 6M, improvements were observed in 59% of patients receiving 10 kHz SCS vs. only 9% of patients receiving CMM alone. Sensory improvements were durable as 65% of patients receiving 10 kHz SCS had improvements at 24M.

In total, 154 patients received an SCS implant. There were eight (5.2%) study-related infections (n=3 resolved; n=5 (3.2%) explanted), which is within the range reported across all SCS patient populations (2.5-10%).

Discussion/Conclusion:
The results of this RCT demonstrate that 10 kHz SCS provides durable reductions in pain and pain-associated effects on health-related quality of life with acceptable safety, now observed through 24-month follow-up. The durable sensory function improvements highlight the disease-modifying potential of 10 kHz SCS.