10-kHz Spinal Cord Stimulation Treatment for Painful Diabetic Neuropathy: Results from Post-Hoc Analysis of the SENZA-PPN Study

Abstract

Aim: Previous studies of 10 kHz spinal cord stimulation demonstrated its safety and efficacy for treatment of neuropathic pain of the trunk and/or limbs. This study analyzed data from a subset of subjects with painful diabetic neuropathy enrolled in a prospective, multicenter study of peripheral polyneuropathy with various etiologies. Materials & methods: Of the eight subjects that had permanent devices, seven attended the 12-month follow-up assessment. Results & conclusion: At 12 months, 6/7 subjects were treatment responders (≥50% pain relief) and had pain remission (visual analog scale ≤ 3.0 cm). Worsening of neurologic deficits was not reported in any subject. Instead, 5/7 subjects showed improvements in sensory testing and/or reflexes. These results support further investigation of 10 kHz spinal cord stimulation as a safe and effective treatment for intractable painful diabetic neuropathy.

Keywords::

• 10 kHz SCS
• painful diabetic neuropathy
• painful polyneuropathy
• VAS

Author contributions

V Galan, J Scowcroft, P Chang, S Li and P Staats were involved in data collection and interpretation of the results. J Subbaroyan was involved in design, conceptualization, analysis and preparing the outline for the manuscript. A Rotte contributed to the design, preparation of outline and worked with the medical writer in preparing the initial draft. All the authors have reviewed and approved the final version of this manuscript.

Financial & competing interests disclosure

The study was funded by Nevro Corp. Vincent Galan is a consultant to Medtronic. James Scowcroft is a consultant to Nevro Corp. S Li is a consultant to Nevro Corp. P Staats is a consultant Medtronic, SPR therapeutics, electroCore, Nalu Sponsored research Nevro, Saluda. A Rotte and J Subbaroyan are employees of Nevro Corp. Medical writing support was provided by E MackLaren, Galen Medical Writing LLC (drafting the manuscript) and M Bhandaru (preparing the illustrations) and was funded by Nevro Corp. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Additional information

Funding

The study was funded by Nevro Corp. Vincent Galan is a consultant to Medtronic. James Scowcroft is a consultant to Nevro Corp. S Li is a consultant to Nevro Corp. P Staats is a consultant Medtronic, SPR therapeutics, electroCore, Nalu Sponsored research Nevro, Saluda. A Rotte and J Subbaroyan are employees of Nevro Corp. Medical writing support was provided by E MackLaren, Galen Medical Writing LLC (drafting the manuscript) and M Bhandaru (preparing the illustrations) and was funded by Nevro Corp. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. No writing assistance was utilized in the production of this manuscript.