Bian Zhiyuan, Wang Jiawei, Fang Fei, Yu Binyan, Shi Yan, Wan Yijia, Hong Mei, Ji Conghua, Shao Xiaomei, Liang Yi, Fang Jianqiao, Sun Jing
The Third Clinical College of Zhejiang Chinese Medical University, Hangzhou, China.
Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China.
Front Neurol. 2024 Nov 20;15:1471605. doi: 10.3389/fneur.2024.1471605. eCollection 2024.
Bell palsy (BP) is the most common cause of acute peripheral facial palsy which leads to functional and esthetic disturbances in patients and has a negative influence on daily living. Electroacupuncture (EA) has been considered an alternative treatment for improving facial function in patients with BP. However, there is no agreement on the preferred waveform type of the EA for treating BP.
This is a study protocol for a pilot randomized, two-arm, three-center, clinical trial at the Third Affiliated hospital of Zhejiang Chinese Medical University, the First Affiliated hospital of Zhejiang Chinese Medical University, and the Hangzhou First People's Hospital. The trial began in November 2023 and is expected to end in December 2025. Sixty patients with BP whose electroneurography (ENoG) value is at least 20% and 60 patients with BP whose ENoG value is less than 20% will be randomly assigned to the low frequency continuous waveform group or the intermittent waveform group in a 1:1 ratio. Participants will receive 4 weeks of EA treatment and clinical assessments. The primary outcome is the change from baseline score of the Facial Nerve Grading System 2.0. The secondary outcomes include the change from baseline score of the Sunnybrook grading scale and the change from baseline amplitude of the compound muscle action potential of the affected side in the ENoG tests.
This is the first study protocol to compare the treatment effect and safety of EA with low frequency continuous waveform and intermittent waveform for different severity groups of BP. This study will contribute to subsequent studies for exploring optimal EA parameters for BP treatment.
ClinicalTrials.gov, NCT06063954.
贝尔面瘫（BP）是急性周围性面瘫最常见的病因，可导致患者出现功能和美观障碍，对日常生活产生负面影响。电针（EA）被认为是改善BP患者面部功能的一种替代治疗方法。然而，对于治疗BP的电针首选波形类型尚无共识。
这是一项在浙江中医药大学附属第三医院、浙江中医药大学附属第一医院和杭州市第一人民医院进行的前瞻性随机、双臂、三中心临床试验的研究方案。试验于2023年11月开始，预计于2025年12月结束。60例神经电图（ENoG）值至少为20%的BP患者和60例ENoG值小于20%的BP患者将按1:1的比例随机分配到低频连续波形组或间歇波形组。参与者将接受4周的电针治疗和临床评估。主要结局是面神经分级系统2.0的基线评分变化。次要结局包括阳光布鲁克分级量表的基线评分变化和ENoG测试中患侧复合肌肉动作电位的基线波幅变化。
这是第一项比较低频连续波形和间歇波形电针对不同严重程度BP组治疗效果和安全性的研究方案。本研究将为后续探索BP治疗最佳电针参数的研究做出贡献。
ClinicalTrials.gov，NCT06063954。
