IDF21-0081 Effect of High-Frequency 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy – A Randomized Controlled Trial

Abstract

Background: The World Health Organization estimates 422 million persons with diabetes globally and approximately 20% with painful diabetic neuropathy (PDN). Current treatment options are ineffective for many patients; however, previous results suggest high-frequency (10kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms. Aim: Prospective, multicenter RCT to evaluate the effectiveness of 10 kHz SCS (Nevro Corp.) plus conventional medical management (CMM) compared with CMM alone for persons with refractory PDN. Method: Participants had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), hemoglobin A1c ≤10%, and were randomized 1:1 between treatment arms. Outcomes included pain, neurological function, and quality of life over 12 months. Patients could opt to crossover to the alternative treatment at 6 months if they had insufficient pain relief (<50%), were dissatisfied, and their physician deemed it was medically appropriate. Results: Baseline characteristics were similar between groups. The mean age of participants was 60.8 years (SD 10.7) with mean hemoglobin A1c of 7.4% (SD 1.2%). Median duration of diabetes was 10.9 years (IQR 6.3-16.4) with median 5.6 years (IQR 3.0-10.1) of peripheral neuropathy symptoms. At 6 months, 82% of the CMM group crossed over to SCS treatment and none in the 10 kHz SCS group crossed over to CMM. In total, 154 patients underwent permanent SCS device implant; 5 (3.2%) were explanted, all due to infection. Participants originally randomized to 10 kHz SCS as well as those who crossed over demonstrated clear, sustained benefits in lower limb pain, pain interference with daily living, sleep quality, and improvement on neurological examination at 12-month follow-up (Table). TableData shown as mean (95% CI) or proportions.CMM Pre- and Post-crossover to 10 kHz SCS10 kHz SCSBaseline6 Months (CMM only)12 Months (6 mo CMM, 6 mo SCS)Baseline6 Months12 MonthsLower Limb Pain VAS17.2 cm (6.8-7.6 cm)7.4 cm (7.0-7.8 cm)2.0 cm (1.6-2.4 cm)7.6 cm (7.2-7.9 cm)1.7 cm (1.3-2.1 cm)1.7 cm (1.3-2.1 cm)Pain relief from baseline--6.7% (-15.0-1.7%)70.3% (63.4-77.1%)-76.3% (70.7-81.9%)77.1% (71.8-82.3%)Pain interference with mood & daily activities (BPI-DPN)25.9 (5.4-6.4)6.2 (5.6-6.8)2.1 (1.6-2.6)6.2 (5.8-6.7)2.2 (1.7-2.6)1.9 (1.5-2.3)Impact of pain on sleep VAS (PSQ-3)36.7 cm (6.1-7.2 cm)7.0 cm (6.3-7.6 cm)2.7 cm (2.0-3.3 cm)5.9 cm (5.4-6.5 cm)2.1 cm (1.6-2.5 cm)2.1 cm (1.6-2.6 cm)Participants with improvement on neurological examination-0/52 (0%)32/52 (62%)-43/73 (59%)52/76 (68%)110 cm visual analog scale. 2Brief Pain Inventory for Diabetic Peripheral Neuropathy questionnaire. 3Pain and Sleep Questionnaire Three-Item index. Open table in a new tab 110 cm visual analog scale. 2Brief Pain Inventory for Diabetic Peripheral Neuropathy questionnaire. 3Pain and Sleep Questionnaire Three-Item index. Discussion: This is the largest RCT to date of SCS management in PDN. Substantial improvements with high-frequency (10kHz) SCS were sustained over 12 months and support this treatment for PDN patients with refractory symptoms.