STUDY PROTOCOL article
Front. Neurol.
Sec. Neurotechnology
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1611970
This article is part of the Research TopicIntegrating Technology and Policy for Enhanced Neurological and Mental Health OutcomesView all articles
10 kHz spinal cord stimulation versus Traditional low-frequency spinal cord stimulation for the treatment of diabetes peripheral neuropathic pain: study protocol for a multi-center randomized controlled clinical trial
Provisionally accepted
Chen Li1
Chun-Hua Liu1
Yi-Fan Li2Hui-Min Hu1Qing Shi1An-Xiang Liu1Wen-Hui Liu1Yi Zhang2
Peng Mao2*Bi-Fa Fan2*- 1Graduate School of Beijing University of Chinese Medicine, Beijing, China
- 2Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China
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Background: Diabetic peripheral neuropathic pain (DPNP), affecting approximately 50% of diabetes patients, imposes major burdens on quality of life and healthcare systems, while current therapies including pharmacotherapy and conventional spinal cord stimulation remain limited by insufficient efficacy and adverse effects. Our study aims to evaluate the clinical efficacy and safety of 10 kHz high-frequency spinal cord stimulation (HF-SCS) compared to traditional low-frequency SCS (T-SCS) in alleviating DPNP.Methods: This prospective, randomized, controlled, multicenter trial will enroll 100 participants with DPNP. Patients aged 18-80 with chronic (≥6-month) lower limb pain will be randomly assigned to HF-SCS (10 kHz) versus T-SCS (40-60 Hz). The primary outcome is the treatment efficacy rate, defined as ≥50% reduction in numeric rating scale (NRS) scores at 3 months post-intervention. Secondary outcomes include improvements in quality of life (Short Form 12), sleep quality (Athens Insomnia Scale), psychological status (Beck Depression Inventory), neuropathy severity (Michigan Neuropathy Screening Instrument), and microcirculatory parameters assessed via infrared thermography. Safety evaluations encompass adverse events, laboratory tests, and imaging findings.Discussion: This study seeks to provide robust evidence on the superiority of HF-SCS in pain relief, functional improvement, and microcirculatory benefits, potentially establishing it as a preferred neuromodulation strategy for DPNP. Findings may advance clinical practice by addressing unmet needs in chronic pain management through targeted, mechanism-driven interventions.Clinical Trial Registration: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR2300078291.
Keywords: Diabetic peripheral neuropathic pain, high-frequency spinal cord stimulation, randomized controlled trial, Neuromodulation, protocol
Received: 15 Apr 2025; Accepted: 06 May 2025.
Copyright: © 2025 Li, Liu, Li, Hu, Shi, Liu, Liu, Zhang, Mao and Fan. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Peng Mao, Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China
Bi-Fa Fan, Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.