Introduction and Objective: Individuals with PDN experience substantial reductions in quality of life due to both pain and loss of sensory function. A multicenter RCT evaluated the effectiveness of 10kHz SCS plus conventional medical management (CMM) versus CMM alone for improving pain and sensory function in people with PDN.Methods: Eligible PDN participants with lower-limb pain ≥5 cm on a 10-cm visual analog scale and sensory loss defined by a modified Toronto Neuropathic Clinical Score (mTNCS) >5 were randomized 1:1 to receive 10kHz-SCS (Nevro Corp.) or CMM alone (NCT05777317). The key endpoints were pain responder rate (≥50% pain relief) and sensory improvement of ≥3 mTNCS points, assessed by an allocation-blinded evaluator. Participants could cross over to the alternate treatment after 6 months (6M), with follow-up of 12 months (12M).Results: Of 91 randomized participants, 50 were assigned to CMM and 41 to SCS. At 6M both the pain (P<0.0001) and the sensory (P=0.014) responder rate endpoints were met. None of the SCS group crossed over to CMM, while 92% of the CMM crossed over to SCS treatment. One explant (1.4%) occurred for implant site pain, with none for lack of efficacy. Improvements in both sensory function and pain were significant and sustained at 12 M, including crossovers (Figure 1).Conclusion: The study provides the first prespecified evidence of significant sensory function improvement in PDN participants using 10kHz SCS.
E.S. Siraj: Speaker’s Bureau; Current; Boehringer Ingelheim International GmbH. Research Support; Current; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Current; Novo Nordisk. Consultant; Current; Novo Nordisk. Consultant; Ended; Eli Lilly and Company. Consultant; Current; Nevro Corp. R.W. Hurley: Research Support; Current; Nevro Corp. Consultant; Current; State Farm Insurance. Research Support; Current; National Institutes of Health. S.M. Sills: Research Support; Current; Nevro Corp. R. Pop-Busui: Board Member; Current; American Diabetes Association. Consultant; Current; Averitas Pharma, Inc. Research Support; Current; Bayer AG. Consultant; Current; Lexicon Pharmaceuticals, Inc. Research Support; Current; National Institutes of Health. Consultant; Current; Novo Nordisk, Roche Diagnostics, Vertex Pharmaceuticals Incorporated. Consultant; Ended; Viatris Inc. D. Armstrong: None. A.J. Boulton: None. Q. Nguyen: None. B.L. Levy: Advisory Panel; Current; Nevro Corp., CeQur SA. S. Tesfaye: Advisory Panel; Current; AstraZeneca, Nevro Corp. Speaker’s Bureau; Current; Novo Nordisk, Viatris Inc., Medtronic. Advisory Panel; Current; Bayer AG, Wörwag Pharma GmbH & Co. KG. Advisory Panel; Ended; Procter & Gamble, Grünenthal Group. G. Grunberger: Speaker’s Bureau; Current; Abbott Diabetes, Eli Lilly and Company. Advisory Panel; Current; MannKind Corporation, Vertex Pharmaceuticals Incorporated. E.A. Petersen: Consultant; Current; Nevro Corp., Biotronik, Saluda Medical, Medtronic. Other – sponsored research at institution; Ended; Nevro Corp. Other – sponsored research at institution; Current; Saluda Medical, ShiraTronics. Stock/Shareholder; Current; SynerFuse, US Pain Care, Equanimity.ai. S. Nakhle: None. J. Jameson: Consultant; Current; SPR, Boston Scientific Corporation. Consultant; Ended; Nevro Corp., Abbott. M. Guirguis: Consultant; Current; Boston Scientific Corporation, Saluda Medical, Averitas Pharma, Inc., Avanos Medical, Inc. Consultant; Ended; Vertex Pharmaceuticals Incorporated. R. Province-Azalde: Employee; Current; Nevro Corp. D. Caraway: Employee; Current; Nevro Corp.
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