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STUDY PROTOCOL article

Front. Neurol.
Sec. Neuromuscular Disorders and Peripheral Neuropathies
Volume 15 - 2024 | doi: 10.3389/fneur.2024.1471605

Study protocol for a randomized trial comparing two electroacupuncture waveforms for different severity groups of Bell palsy

Provisionally accepted
Zhiyuan Bian Zhiyuan Bian 1Jiawei Wang Jiawei Wang 1Fei Fang Fei Fang 1Binyan Yu Binyan Yu 2Yan Shi Yan Shi 3Yijia Wan Yijia Wan 2Mei Hong Mei Hong 3Conghua Ji Conghua Ji 4Xiaomei Shao Xiaomei Shao 1Yi Liang Yi Liang 1Jianqiao Fang Jianqiao Fang 1Jing Sun Jing Sun 1*
  • 1 The Third Clinical College of Zhejiang Chinese Medical University, Hangzhou, China., Hangzhou, Zhejiang, China
  • 2 Department of Acupuncture and Moxibustion, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, China
  • 3 Department of Acupuncture and Massage, Hangzhou First People’s Hospital, Hangzhou, Hangzhou, China
  • 4 Zhejiang Chinese Medical University, Hangzhou, Zhejiang Province, China

The final, formatted version of the article will be published soon.

    Background: 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.Methods: 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 four 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.Discussion: 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.Clinical trial registration: ClinicalTrials.gov, ID: NCT06063954.

    Keywords: Bell Palsy, Electroacupuncture, waveform, randomized, Pilot Trial, protocol Bell palsy, protocol

    Received: 28 Jul 2024; Accepted: 05 Nov 2024.

    Copyright: © 2024 Bian, Wang, Fang, Yu, Shi, Wan, Hong, Ji, Shao, Liang, Fang and Sun. 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: Jing Sun, The Third Clinical College of Zhejiang Chinese Medical University, Hangzhou, China., Hangzhou, Zhejiang, 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.