Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial

Abstract Background Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis. It causes critical problems in facial appearance of patient as well as social and psychological problems. This study aims to evaluate the efficacy and safety of Thread-embedding acupunctu...

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Autores principales: Binyan Yu, Lihua Xuan, Yutong Jin, Shan Chen, Shan Liu, Yijia Wan
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Lenguaje:EN
Publicado: BMC 2021
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Acceso en línea:https://doaj.org/article/4c37ae6dd43b40e1a024d16ff69a69f7
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spelling oai:doaj.org-article:4c37ae6dd43b40e1a024d16ff69a69f72021-11-08T11:03:04ZEfficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial10.1186/s13063-021-05696-61745-6215https://doaj.org/article/4c37ae6dd43b40e1a024d16ff69a69f72021-10-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05696-6https://doaj.org/toc/1745-6215Abstract Background Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis. It causes critical problems in facial appearance of patient as well as social and psychological problems. This study aims to evaluate the efficacy and safety of Thread-embedding acupuncture (TEA) for the management of facial expression muscles atrophy after peripheral facial paralysis. Methods This is a patient-assessor blinded, randomized, sham-controlled trial. A total of fifty-six eligible patients will be randomly divided into TEA (n=28) and sham TEA (STEA) (n=28) groups. Both groups will receive TEA or STEA treatment at the frontal muscle and the depressor anguli oris muscle, at one predefined points once a week for eight weeks. Additionally, both groups will receive traditional acupuncture treatment at ten acupoints (GB20, LI4, LR3, GB12, ST7, SI18, LI20, BL2, SJ23, ST4) twice a week for eight weeks as a concurrent treatment. B-mode ultrasonography will be used to assess the changes in facial expression muscle thickness ratio of the affected/healthy side at baseline and at 10 weeks after screening, as the primary outcome. House-Brackmann Grade and lip mobility score will be measured and analyzed at baseline and 4, 8, 10, and 12 weeks after screening, as secondary outcomes. Discussion The study will compare TEA with sham TEA to explore the feasibility for TEA in improving facial expression muscles atrophy after peripheral facial paralysis. Trial registration Chinese Clinical Trial Registry, ChiCTR1900027170. Registered on 3 November 2019, http://www.chictr.org.cn/edit.aspx?pid=45173&htm=4Binyan YuLihua XuanYutong JinShan ChenShan LiuYijia WanBMCarticlefacial expression muscles atrophyperipheral facial paralysisthread-embedding acupunctureRandomized controlled trialMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)
institution DOAJ
collection DOAJ
language EN
topic facial expression muscles atrophy
peripheral facial paralysis
thread-embedding acupuncture
Randomized controlled trial
Medicine (General)
R5-920
spellingShingle facial expression muscles atrophy
peripheral facial paralysis
thread-embedding acupuncture
Randomized controlled trial
Medicine (General)
R5-920
Binyan Yu
Lihua Xuan
Yutong Jin
Shan Chen
Shan Liu
Yijia Wan
Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
description Abstract Background Facial expression muscles atrophy is one kind of sequelae after peripheral facial paralysis. It causes critical problems in facial appearance of patient as well as social and psychological problems. This study aims to evaluate the efficacy and safety of Thread-embedding acupuncture (TEA) for the management of facial expression muscles atrophy after peripheral facial paralysis. Methods This is a patient-assessor blinded, randomized, sham-controlled trial. A total of fifty-six eligible patients will be randomly divided into TEA (n=28) and sham TEA (STEA) (n=28) groups. Both groups will receive TEA or STEA treatment at the frontal muscle and the depressor anguli oris muscle, at one predefined points once a week for eight weeks. Additionally, both groups will receive traditional acupuncture treatment at ten acupoints (GB20, LI4, LR3, GB12, ST7, SI18, LI20, BL2, SJ23, ST4) twice a week for eight weeks as a concurrent treatment. B-mode ultrasonography will be used to assess the changes in facial expression muscle thickness ratio of the affected/healthy side at baseline and at 10 weeks after screening, as the primary outcome. House-Brackmann Grade and lip mobility score will be measured and analyzed at baseline and 4, 8, 10, and 12 weeks after screening, as secondary outcomes. Discussion The study will compare TEA with sham TEA to explore the feasibility for TEA in improving facial expression muscles atrophy after peripheral facial paralysis. Trial registration Chinese Clinical Trial Registry, ChiCTR1900027170. Registered on 3 November 2019, http://www.chictr.org.cn/edit.aspx?pid=45173&htm=4
format article
author Binyan Yu
Lihua Xuan
Yutong Jin
Shan Chen
Shan Liu
Yijia Wan
author_facet Binyan Yu
Lihua Xuan
Yutong Jin
Shan Chen
Shan Liu
Yijia Wan
author_sort Binyan Yu
title Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
title_short Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
title_full Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
title_fullStr Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
title_full_unstemmed Efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
title_sort efficacy and safety of thread embedding acupuncture for facial expression muscles atrophy after peripheral facial paralysis: study protocol for a randomized controlled trial
publisher BMC
publishDate 2021
url https://doaj.org/article/4c37ae6dd43b40e1a024d16ff69a69f7
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