STUDY PROTOCOL article
Front. Neurol.
Sec. Neuromuscular Disorders and Peripheral Neuropathies
Volume 16 - 2025 | doi: 10.3389/fneur.2025.1668688
This article is part of the Research TopicAdvances in the Diagnosis and Treatment of Peripheral Facial Palsy: From Pathophysiology to Rehabilitation/RecoveryView all 4 articles
Effectiveness and safety of thread embedding acupuncture for facial nerve palsy sequelae: A protocol for a multicenter, assessor-blinded, randomized, controlled clinical trial
Provisionally accepted
- 1Kyung Hee University Hospital at Gangdong, Gangdong-gu, Republic of Korea
- 2Jaseng Medical Foundation, Gangnam-gu, Republic of Korea
- 3Kyung Hee University, Dongdaemun-gu, Republic of Korea
- 4Pusan National University - Yangsan Campus, Yangsan-si, Republic of Korea
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Introduction: Facial nerve palsy can result in various sequelae. Recent reviews and clinical studies reported that thread-embedding acupuncture is a safe treatment and can improve facial nerve palsy sequelae. This trial aims to confirm the effectiveness and safety of thread-embedding acupuncture for patients with facial nerve palsy sequelae. Methods: A multicenter, randomized, assessor-blinded clinical trial will be conducted. 142 participants will be recruited by eligibility criteria and be randomly divided into two groups. The intervention group will receive thread-embedding acupuncture in addition to electroacupuncture, while the control group will be given only electroacupuncture. The primary outcome is a change in the physical function score of the Facial Disability Index. The secondary outcome is change in Sunnybrook Facial Grading System, Social/Well-being function score of Facial Disability Index, Synkinesis Assessment Questionnaire, Numeric Rating Scale of stiffness by facial region, Patient Global Impression of Change, Euro-Qol 5-Dimension 5-level, Economic evaluation questionnaire and adverse events. Assessment points include before treatment (Week 1), after treatment completion (Week 6), two weeks post-treatment completion (Week 8, Primary endpoint), and ten weeks post-treatment completion (Week 16). Conclusion: This randomized controlled trial will assess the effectiveness and safety of thread-embedding acupuncture treatment alongside electroacupuncture for facial nerve palsy, using proper sample sizes and rigorous methodologies to address previous research limitations. Clinical trial registration: KCT0008551 (https://cris.nih.go.kr/cris/search/detailSearch.do?seq=25846&status=5&seq_group=24726&search_ page=M)
Keywords: Facial nerve palsy, thread embedding acupuncture, Facial Disability Index, Facial stiffness, Synkinesis, randomized controlled trial
Received: 18 Jul 2025; Accepted: 23 Oct 2025.
Copyright: © 2025 Kim, Goo, Lee, Kim, Park, Kim and Nam. 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: Sang-Soo Nam, dangun66@gmail.com
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