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Abstract Details

10 kHz Spinal Cord Stimulation for Treatment of Painful Diabetic Neuropathy-A Multicenter Randomized Controlled Trial
Pain
P11 - Poster Session 11 (8:00 AM-9:00 AM)
6-003
Prospective, multicenter, randomized controlled trial (SENZA-PDN) to document the impact of 10 kHz spinal cord stimulation (SCS) on painful diabetic neuropathy (PDN).
The Centers for Disease Control and Prevention estimates there are 29 and 86 million people in the US living with diabetes and prediabetes, respectively.1 Approximately 20% of patients with diabetes will develop PDN,2 a debilitating, progressive chronic pain condition that significantly impacts patients’ health-related quality of life (HRQoL). Neither pharmacological treatments nor low-frequency SCS has provided significant, long-term relief for PDN patients;3-6 however, preliminary observational data suggest 10 kHz SCS may relieve pain and reverse sensory deficits from peripheral polyneuropathy.7

In total, 216 subjects with PDN were assigned 1:1 to 10 kHz SCS combined with conventional medical management (CMM) or CMM alone. Key inclusion criteria included: clinical diagnosis of PDN with symptoms ≥12 months, average lower limb pain intensity ≥5 cm (on a 0-10 cm visual analog scale [VAS]), and appropriate candidate for SCS. Key exclusion criteria included: hemoglobin A1c >10%, daily opioid dosage >120 mg morphine equivalents, and average upper limb pain intensity ≥3 cm.

The primary endpoint compares responder rates (≥50% pain relief) and safety rates between the treatment groups at 3 months. Secondary endpoints include neurological function, HRQoL, sleep quality, patient satisfaction, and cost-effectiveness data. Participant follow-up will last 24 months.
Enrollment in SENZA-PDN commenced in 2017 and completed in 2019. Screening 430 candidates resulted in 113 subjects randomized to 10 kHz SCS+CMM and 103 to CMM alone. Outcomes reported will include demographics, and 3-month follow-up of average VAS scores, responder rates, adverse events, neurological assessment, and other secondary and observational outcomes.
The SENZA-PDN study is the largest RCT to date of SCS management of PDN patients and will help inform the place of 10 kHz SCS in the PDN treatment continuum.
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.
No disclosure on file
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Judith A. White, MD, PhD (Swedish Neurosciences Institute Balance Center) No disclosure on file
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Neel Mehta, Neel Mehta (EpiFinder Inc.) No disclosure on file
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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.
No disclosure on file
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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.
No disclosure on file
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