In June, the Journal of Diabetes Science and Technology published an article entitled “Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic Neuropathy” authored by Dr. David Armstrong, Professor of Surgery Keck School of Medicine of University of Southern California (USC), and Dr. George Grunberger, Past President of the American Association of Clinical Endocrinologists. The publication concluded, “High frequency spinal cord simulation appears to hold promise in treatment of painful diabetic neuropathy. We look forward to future works in the literature that will further elucidate these promising findings.”
Nevro HFX has been used to treat over 80,000 patients with chronic pain with 10 kHz Therapy, since 2015, when it received a superiority claim versus traditional SCS from the FDA. In July 2021, Nevro’s high-frequency, 10 kHz spinal cord stimulation (SCS) therapy received FDA approval for an expanded indication to treat painful diabetic neuropathy (PDN) based on the results of the SENZA-PDN RCT.
The authors note that in PDN, “A common challenge has been in predicting which patients will respond to which treatments…The ability to trial 10 kHz SCS prior to having a permanent implantation procedure affords reassurance patients as well as implanting physicians of the potential benefits from the therapy.”
This publication evaluated 12 month outcomes of the SENZA-PDN RCT, previously published in Diabetes Care2 and more recently Mayo Clinic Proceedings3. The SENZA-PDN RCT includes 216 patients across 18 US sites. Patients were randomized to receive 10 kHz Therapy or optimized conventional medical management (CMM) with the option to cross-over at 6 months if they were not responding to or were unhappy with treatment. At 12 months, reported outcomes included:
- 86% of people with painful diabetic neuropathy experienced substantial, long-term relief2
- 77% average pain relief for painful diabetic neuropathy2
- 68% of people with painful diabetic neuropathy reported improved neurological function, including motor strength, reflexes, and function2
- 92% of participants were satisfied or very satisfied with the 10 kHz SCS Treatment3
“Although no patients crossed from 10 kHz SCS to CMM, 93% of eligible CMM patients crossed over to 10 kHz SCS. The results post-implant were similar to those for patients originally randomized to 10 kHz SCS: 70.3% mean pain relief, 84% of patients with ≥50% pain relief from baseline, and 62% of patients observed to have meaningful neurological improvement.”
The authors went on to note the significance of the SENZA-PDN findings. “The potential disease-modifying findings of this study in terms of neurological function may be of significant value. With pain relief and improved sensory perception in the feet…patients will be able to meaningfully participate in activities of daily living and potentially avoid injuries.”
Based on the strong evidence for 10 kHz SCS from SENZA-PDN, Pop-Busui et al. (2022) recommended 10 kHz SCS as a potential non-pharmacological therapeutic approach to treat painful diabetic peripheral neuropathy.4 Today, patients with PDN who could benefit from this treatment are underserved. There is an unmet need to identify these patients along the disease spectrum and offer them proven pain relief timely. “Strong referral pathways, interdisciplinary care models, and dissemination of the study findings to primary care providers…could be important for patient access to the therapy.”
To find a pain physician or neurosurgeon in your area, visit hfxforpdn.com/find-a-physician, or to learn more, go to hfxforpdn.com/healthcare-providers.
- Armstrong D, Grunberger G. Stimulating Results Signal a New Treatment Option for People Living With Painful Diabetic. Journal of Diabetes Science and Technology, July 2022.
- Petersen EA, et al. Durability of high-frequency 10 kHz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments: 12-month results from a randomized controlled trial. Diabetes Care, November 2021.
- Petersen EA, et al. High-Frequency 10-kHz Spinal Cord Stimulation Improves Health-Related Quality of Life in Patients With Refractory Painful Diabetic Neuropathy: 12-Month Results From a Randomized Controlled Trial. Mayo Clinic Proceedings: Innovations, Quality & Outcomes, August 2022.
- Pop-Busui, R. et al. Diagnosis and Treatment of Painful Diabetic Peripheral Neuropathy, ADA Clinical Compendia Series, 2022.
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