16-LB - Long-Term 10 kHz Spinal Cord Stimulation in Painful Diabetic Neuropathy: A Randomized Controlled Trial
Author Block: ERIKA PETERSEN, JAMES SCOWCROFT, ELIZABETH S. BROOKS, JUDITH L. WHITE, KASRA AMIRDELFAN, MAGED GUIRGUIS, JIJUN XU, DENIS G. PATTERSON, VINCENT GALAN, NEEL MEHTA, PAUL W. WU, CHARLES ARGOFF, CHRISTIAN E. NASR, ROD TAYLOR, SENZA-PDN STUDY GROUP, Little Rock, AR, Lees Summit, MO, Redwood City, CA, Orlando, FL, Walnut Creek, CA, New Orleans, LA, Cleveland, OH, Reno, NV, Stockbridge, GA, New York, NY, Ft. Lauderdale, FL, Albany, NY, Glasgow, United Kingdom
Disclosure Block: E.Petersen: Consultant; Self; Abbott, Medtronic, Nevro Corp., Research Support; Self; Neuros Medical, Inc., Nevro Corp., ReNeuron Group plc, Saluda, Stock/Shareholder; Self; SynerFuse. N.Mehta: Research Support; Self; Nevro Corp.. P.W.Wu: None. C.Argoff: Consultant; Self; Nevro Corp., Vertex Pharmaceuticals Incorporated, Other Relationship; Self; Amgen Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Speaker's Bureau; Self; AbbVie Inc.. C.E.Nasr: Advisory Panel; Self; Nevro Corp.. R.Taylor: Consultant; Self; Nevro Corp.. Senza-pdn study group: n/a. J.Scowcroft: Research Support; Self; Boston Scientific Corporation, Nevro Corp.. E.S.Brooks: Employee; Self; Nevro Corp.. J.L.White: Advisory Panel; Self; Eli Lilly and Company, Nevro Corp.. K.Amirdelfan: Advisory Panel; Self; Biotronik, Nevro Corp., Consultant; Self; Boston Scientific Corporation. M.Guirguis: Consultant; Self; Avanos medical , Nevro Corp.. J.Xu: None. D.G.Patterson: Advisory Panel; Self; Advanced Infusion Systems (AIS), Spark Biomedical, Consultant; Self; Vivex Biologics, Other Relationship; Self; Abbott Laboratories, CornerLoc, Saluda, Vertos Medical Inc., Speaker's Bureau; Self; AbbVie Inc., Amgen Inc., Lundbeck. V.Galan: None.
Background: Seven million US adults are living with painful diabetic neuropathy (PDN) with current treatments ineffective for many. Recent RCT results demonstrate high-frequency (10 kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms.
Methods: Prospective, multicenter RCT assigned 216 patients 1:1 to 10 kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone (NCT03228420). Patients had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), and hemoglobin A1c ≤10%. Outcomes included pain, neurological function, and quality of life over 12 months. Patients could opt to crossover to the alternative treatment at 6 months.
Results: Baseline characteristics were similar between groups. 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 SCS implant; 5 (3.2%) were explanted for infection. At 12-month follow-up, there were clear, sustained benefits of 10 kHz SCS in lower limb pain, pain interference with daily living, sleep quality, and activity (Figure). Most patients treated with 10 kHz SCS also showed improvements on neurological examination.
Conclusion: The largest RCT to date of SCS management of PDN demonstrates durable pain relief and improved quality of life over 12 months with high-frequency (10 kHz) SCS.