Abstract Details

Title Durability of 10-kHz Spinal Cord Stimulation for Painful Diabetic Neuropathy: 18-Month Multicenter Randomized Controlled Trial Results

Topic Pain

Presentation(s) P1 - Poster Session 1 (9:00 AM-5:00 PM)

Poster/Presentation
Number 445

Objective Prospective, multicenter, randomized controlled trial (SENZA-PDN) to document the impact of 10-kHz spinal cord stimulation (SCS) on painful diabetic neuropathy (PDN).

Background Approximately 6 million US adults are living with PDN and many find conventional treatments ineffective.^1-3 The published 6-month SENZA-PDN data demonstrated 10-kHz SCS substantially relieves pain and may improve sensation in patients with refractory symptoms.⁴

Design/Methods Participants had PDN symptoms ≥12 months, refractory to medications, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), and hemoglobin A1c ≤10%. Patients (n=216) were allocated 1:1 to 10-kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone and followed for 18 months with an option to crossover at 6 months.

Results

Patients assigned 10-kHz SCS experienced substantial, sustained pain relief with 78% improvement over 18 months (baseline VAS=7.6 cm, 18-month VAS=1.7 cm). Additionally, this group reported average 65% reduction in sleep disturbance due to pain and 65% improvement in pain interference with mood and daily activities. No 10-kHz SCS participants elected to crossover.

At 6-month follow-up, 93% of eligible CMM patients elected to crossover and results were similar to those seen in the original SCS group: 70% pain relief over 18 months (baseline VAS=7.4 cm, 18-month VAS=2.2 cm). Crossover patients reported average 54% reduction in sleep disturbance due to pain and 62% improvement in pain interference. There were no significant differences between the crossover results and those observed in patients originally assigned 10-kHz SCS.

There were no stimulation-related neurological deficits and no explants due to ineffectiveness. There were 6 total explants (3.9%), 5 due to procedure-related infections and 1 as a precaution for endocarditis.

Conclusions SENZA-PDN, the largest RCT to-date of SCS management of PDN, will inform the treatment continuum. Observed short-term results are durable over 18 months for patients with symptoms refractory to conservative care.

Authors/Disclosures
Erika Petersen, MD PRESENTER	Erika Petersen, MD has received personal compensation in the range of $50,000-$99,999 for serving as a Consultant for Nevro. Erika Petersen, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Abbott Neuromodulation. Erika Petersen, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Medtronic. Erika Petersen, MD has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Vertos. Erika Petersen, MD has received personal compensation in the range of $10,000-$49,999 for serving as a Consultant for Saluda. Erika Petersen, MD has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for American Society of Pain and Neurosciences. Erika Petersen, MD has received personal compensation in the range of $0-$499 for serving as an officer or member of the Board of Directors for SynerFuse. Erika Petersen, MD has stock in SynerFuse. Erika Petersen, MD has stock in neuro.42. The institution of Erika Petersen, MD has received research support from Saluda. The institution of Erika Petersen, MD has received research support from Nevro. The institution of Erika Petersen, MD has received research support from ReNeuron. The institution of Erika Petersen, MD has received research support from Neuros. Erika Petersen, MD has received intellectual property interests from a discovery or technology relating to health care.
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Lisa Brooks	Lisa Brooks has received personal compensation for serving as an employee of Nevro. Lisa Brooks has received stock or an ownership interest from Nevro.
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Charles E. Argoff, MD (Albany Medical Center)	Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Nevro. Dr. Argoff has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for XGene. Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Vertex. Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Scilex. Dr. Argoff has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Colllegium. Dr. Argoff has received personal compensation in the range of $5,000-$9,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Vertex. Dr. Argoff has received personal compensation in the range of $10,000-$49,999 for serving on a Speakers Bureau for Allergan/Abbvie. Dr. Argoff has received personal compensation in the range of $5,000-$9,999 for serving on a Speakers Bureau for Lundbeck. Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Scilex. Dr. Argoff has received personal compensation in the range of $500-$4,999 for serving as an Expert Witness for Scilex. The institution of Dr. Argoff has received research support from Lilly. The institution of Dr. Argoff has received research support from Lundbeck. The institution of Dr. Argoff has received research support from Abbvie. The institution of Dr. Argoff has received research support from Vertex. Dr. Argoff has received publishing royalties from a publication relating to health care.
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