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Review
. 2022 Mar;16(2):332-340.
doi: 10.1177/19322968211060075. Epub 2021 Nov 29.

Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation

Affiliations
Review

Neuromodulation in the Treatment of Painful Diabetic Neuropathy: A Review of Evidence for Spinal Cord Stimulation

Natalie H Strand et al. J Diabetes Sci Technol. 2022 Mar.

Abstract

Background: Neuropathies, the most common complication of diabetes, manifest in various forms, including entrapments, mononeuropathies or, most frequently, a distal symmetric polyneuropathy. Painful diabetic neuropathy (PDN) in the classic "stocking" distribution is a disease of increasing prevalence worldwide and a condition for which standard medical treatment only provides modest relief. Neuromodulation offers a potential alternative to pharmacotherapies given its demonstrated efficacy in other refractory chronic neuropathic pain syndromes. High-quality evidence from randomized controlled trials (RCTs) is available in these other settings for two approaches to spinal cord stimulation (SCS): (1) conventional low-frequency SCS (LF-SCS), which modulates axonal activity in the dorsal column and is paresthesia-dependent, and (2) high-frequency SCS delivered at 10 kilohertz (10 kHz SCS), which targets neurons in the superficial dorsal horn and is paresthesia-independent.

Method: This review examines the evidence for SCS from published RCTs as well as prospective studies exploring the safety and effectiveness of treating PDN with neuromodulation.

Results: Two RCTs enrolling 60 and 36 participants with PDN showed treatment with LF-SCS reduced daytime pain by 45% to 55% for up to two years. An RCT testing 10 kHz SCS versus conventional medical management (CMM) in 216 participants with PDN revealed 76% mean pain relief after six months of stimulation. None of the studies revealed unexpected safety issues in the use of neuromodulation in this patient population.

Conclusion: These well-designed RCTs address the unmet need for improved PDN therapies and provide data on the safety, effectiveness, and durability of SCS therapy.

Keywords: 10 kHz SCS; diabetes; diabetic peripheral neuropathy; neuromodulation; neuropathic pain; painful diabetic neuropathy; spinal cord stimulation.

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Conflict of interest statement

Declaration of Conflicting Interest: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Dr Strand has received consulting fees from Abbott and Nevro, and has stock ownership in Abbott, Dexcom, Nevro, and Tandem Diabetes. Dr Burkey has received consulting fees from Nevro.

Figures

Figure 1.
Figure 1.
Change in mean pain scores over time in PDN RCTs. Abbreviations: PDN, painful diabetic neuropathy; RCT, randomized controlled trial. aDay and night pain scores averaged together.

References

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