10 kHz SCS Provides Durable Pain Relief and Neurological Improvements for Patients with Painful Diabetic Neuropathy: 24-Month RCT Results
Erika Petersen1, Thomas Stauss2, James Scowcroft3, Michael Jaasma4, Judith White5, Shawn Sills6, Kasra Amirdelfan7, Charles Argoff8, Rod Taylor9, David Caraway4, Nagy Mekhail10
1University of Arkansas for Medical Sciences, 2Advanced Pain Management, 3Pain Management Associates, 4Nevro Corp., 5Synexus Research, 6Touchstone Interventional Pain Center, 7IPM Medical Group, 8Albany Medical Center, 9University of Glasgow, 10Cleveland Clinic Foundation

To evaluate the long-term safety and effectiveness of 10 kHz spinal cord stimulation (SCS) for the treatment of painful diabetic neuropathy (PDN).


Approximately 37 million Americans have diabetes,1 and ~ 25% of these patients experience PDN.2 Conventional medical management (CMM), which includes pharmacotherapies, is ineffective for many PDN patients.2 Here we report outcomes through 24-month (24M) follow-up for high-frequency (10 kHz) SCS treatment of PDN.

In this RCT, patients had 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 crossover at 6M.

At 6M, patients receiving 10 kHz SCS experienced average pain relief of 76%, while patients receiving CMM alone experienced average pain increase of 2%. At 6M, no 10 kHz SCS patients crossed over to CMM, while 93% of eligible CMM patients elected to cross over to 10 kHz SCS. Pain relief with 10 kHz SCS was durable as patients experienced average pain relief of 80% at 24M.

At 6M, clinician-assessed neurological improvements were observed in 62% of patients in the 10 kHz SCS arm and 3% in the CMM arm. Neurological improvements were durable as 66% of patients receiving 10 kHz SCS had improvement at 24M.

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 across all/non-diabetic SCS patients (2.5-10%).3


The results demonstrate that 10 kHz SCS provides durable pain relief with acceptable safety. The improvements in neurological function highlight the unique disease-modifying potential of 10 kHz SCS for PDN.

References:  1CDC. National Diabetes Statistics Report; May 2022. 2Shillo et al. Curr Diab Rep 2019; 14(2):162-73. 3Eldabe et al. Pain Med 2016; 17(2):325-36.