Li Chen, Liu Chun-Hua, Li Yi-Fan, Hu Hui-Min, Shi Qing, Liu An-Xiang, Liu Wen-Hui, Zhang Yi, Mao Peng, Fan Bi-Fa
Graduate School, Beijing University of Chinese Medicine, Beijing, China.
Department of Pain Medicine, China-Japan Friendship Hospital, Beijing, China.
Front Neurol. 2025 Jun 4;16:1611970. doi: 10.3389/fneur.2025.1611970. eCollection 2025.
Diabetic peripheral neuropathic pain (DPNP), affecting ~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.
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) vs. 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.
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.
https://www.chictr.org.cn/indexEN.html, identifier: ChiCTR2300078291.
糖尿病性周围神经病理性疼痛（DPNP）影响着约50%的糖尿病患者，给生活质量和医疗系统带来了重大负担，而目前包括药物治疗和传统脊髓刺激在内的治疗方法仍受疗效不足和不良反应的限制。我们的研究旨在评估10kHz高频脊髓刺激（HF-SCS）与传统低频脊髓刺激（T-SCS）相比，在缓解DPNP方面的临床疗效和安全性。
这项前瞻性、随机、对照、多中心试验将招募100名DPNP患者。年龄在18-80岁、患有慢性（≥6个月）下肢疼痛的患者将被随机分配至HF-SCS（10kHz）组或T-SCS（40-60Hz）组。主要结局是治疗有效率，定义为干预后3个月数字评定量表（NRS）评分降低≥50%。次要结局包括生活质量（简明健康状况调查简表12）、睡眠质量（雅典失眠量表）、心理状态（贝克抑郁量表）、神经病变严重程度（密歇根神经病变筛查工具）的改善，以及通过红外热成像评估的微循环参数。安全性评估包括不良事件、实验室检查和影像学检查结果。
本研究旨在为HF-SCS在缓解疼痛、功能改善和微循环益处方面的优越性提供有力证据，有可能将其确立为DPNP的首选神经调节策略。研究结果可能通过针对性的、机制驱动的干预措施满足慢性疼痛管理中未满足的需求，从而推动临床实践的发展。
https://www.chictr.org.cn/indexEN.html，标识符：ChiCTR2300078291。
