Kang Yurong, Hu Hantong, Lin Can, Zheng Yu, Jiang Minjian, Wei Zhouyuan, He Xiaofen, Fang Jianqiao, Jiang Yongliang
Zhejiang Chinese Medical University, Hangzhou, China.
Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, China.
Front Neurol. 2025 Aug 29;16:1609674. doi: 10.3389/fneur.2025.1609674. eCollection 2025.
Diabetic Peripheral Neuropathy (DPN) can markedly diminish patients' quality of life. Current treatments provide limited relief, driving interest in non-invasive options such as moxibustion. Moxibustion, a technique rooted in acupuncture, shows promise for managing pain. However, it lacks standardized protocols for treating DPN, especially concerning moxibustion duration, and its effectiveness for DPN is not well-supported by evidence. Thus, this study seeks to identify the optimal moxibustion duration to relieve DPN symptoms and enhance nerve function, filling an important gap in clinical practice.
Participants will be randomly allocated to three clinical centers, with 30 individuals at each center, and evenly divided among the conventional treatment group, the 15-min moxibustion group, and the 30-min moxibustion group. The conventional treatment group will be administered mecobalamin and epalrestat for a duration of 4 weeks, while the moxibustion groups will receive moxubustion as an add-on therapy treatment twice a week over the same period. The duration of moxibustion differs from the 15-min group, while the procedure remains consistent across the moxibustion groups. The primary outcome is total clinical effectiveness. The second outcomes include electrophysiological examination, the Toronto Clinical Scoring System (TCSS), the Visual Analogue Scale (VAS), the Traditional Chinese Medicine Syndrome Score Scale (TCMS), and infrared thermography testing. The outcomes will be assessed during the baseline period, after the 8th treatment, and at the one-month follow-up.
This trial aims to identify the optimal moxibustion duration for DPN symptom relief and nerve function improvement, offering evidence for standardized clinical protocols. The findings could enhance treatment efficacy, reduce adverse effects, and alleviate DPN's socio-economic burden.
https://clinicaltrials.gov/, NCT06330233.
糖尿病周围神经病变（DPN）会显著降低患者的生活质量。目前的治疗方法缓解效果有限，这激发了人们对艾灸等非侵入性治疗方法的兴趣。艾灸是一种基于针灸的技术，在疼痛管理方面显示出前景。然而，它缺乏治疗DPN的标准化方案，尤其是关于艾灸时长，且其对DPN的有效性缺乏充分证据支持。因此，本研究旨在确定缓解DPN症状和增强神经功能的最佳艾灸时长，填补临床实践中的一项重要空白。
参与者将被随机分配到三个临床中心，每个中心30人，并平均分为传统治疗组、15分钟艾灸组和30分钟艾灸组。传统治疗组将给予甲钴胺和依帕司他，持续4周，而艾灸组将在同一时期每周额外接受两次艾灸治疗。艾灸时长在15分钟组有所不同，而艾灸组的操作过程保持一致。主要结局是总临床疗效。次要结局包括电生理检查、多伦多临床评分系统（TCSS）、视觉模拟评分法（VAS）、中医证候评分量表（TCMS）和红外热成像测试。结局将在基线期、第8次治疗后和1个月随访时进行评估。
本试验旨在确定缓解DPN症状和改善神经功能的最佳艾灸时长，为标准化临床方案提供证据。研究结果可能提高治疗效果，减少不良反应，并减轻DPN的社会经济负担。
