Background: Six million adults in the U.S. are living with painful diabetic neuropathy (PDN) and current treatments are ineffective for many. Preliminary data suggest 10 kHz spinal cord stimulation (SCS) relieves pain and may improve sensation in refractory patients.
Methods: Prospective, multicenter, randomized controlled trial (SENZA-PDN) with 216 subjects assigned 1:1 to 10 kHz SCS (Nevro Corp.) combined with conventional medical management (CMM) or CMM alone. Patients with PDN symptoms ≥12 months, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), hemoglobin A1c ≤10%, and upper limb pain intensity <3cm were included. Outcomes include pain, neurological function, and quality of life.
Results: Randomization of 113 subjects to 10 kHz SCS+CMM and 103 to CMM resulted in groups well-matched at baseline. There were 2 procedure-related infections in the 10 kHz SCS+CMM group (1.8%). At 3-month follow-up, there were clear differences in lower limb pain scores (Fig 1A) and Diabetes Quality of Life (Fig 1B). Patients in the 10 kHz SCS+CMM group demonstrated improvements in sensation on physical examination (Fig 1C) and by patient report of numbness (Fig 1D). In addition, differences between treatment groups were observed in 6-minute walk test distance (Fig 1E) and sleep (Fig 1F).
Conclusion: SENZA-PDN is the largest RCT to-date of SCS management of PDN and will inform the treatment continuum.
E. Petersen: Consultant; Self; Abbott, Medtronic, Neuros Medical, Nevro. Research Support; Self; Medtronic, Neuros Medical, Nevro, ReNeuron. T. Stauss: None. J.L. White: Research Support; Self; Allergan plc., Astellas Pharma Inc., Bayer Healthcare Pharmaceuticals Inc., Bristol-Myers Squibb, Eli Lilly and Company, Fitbit, Inc., Nevro, NovMetaPharma Co. Ltd., Theracos, Inc. S.M. Sills: None. K. Amirdelfan: Consultant; Self; Biotronik, Medtronic, Nevro Corporation, Saluda. M. Guirguis: Consultant; Self; Boston Scientific, nevro incop, spr. J. Xu: None. C. Yu: None. A. Nairizi: None. D.G. Patterson: Research Support; Self; Nevro Corporation. V. Galan: None. N. Mehta: Advisory Panel; Self; Nevro. Research Support; Self; Nevro. S.P. Lad: None. D. DiBenedetto: None. P.W. Wu: None. C.E. Nasr: Other Relationship; Self; Exilxis, Neurogastrx, Nevro Corp. R. Taylor: Consultant; Self; Nevro. E.S. Brooks: Employee; Self; Nevro. J. Subbaroyan: Employee; Self; Nevro Corp. B. Gliner: Employee; Self; Nevro Corp. D.L. Caraway: Employee; Self; Nevro. N. Mekhail: Consultant; Self; Boston Scientific, Nevro, Nuvectra, Relievant, Saluda, Sollis Therapeutics, Vertos Medical. Research Support; Self; Halyard, Mallinckrodt Pharmaceuticals, Mesoblast, Neuros Medical.