NDLI: Efficacy evaluation and mechanism study of electroacupuncture intervention in acute phase of IFP: study protocol for a randomized controlled trial

Content Provider	Springer Nature : BioMed Central
Author	Qin, Yinan Yang, Lihong Zhang, Man Bai, Yang Li, Zexin Zhao, Nana Li, Zhimei Xu, Tianyu Xie, Yue Du, Yuanhao
Abstract	Background Previous studies had already reported the efficacy of electroacupuncture treatment for idiopathic facial nerve palsy (IFP) in a recovery phase; however, the initial use of electroacupuncture in the acute phase remains controversial. Hence, in the present study, we will add electroacupuncture intervention based on oral prednisone tablets in the acute phase of IFP and compare the clinical effects with simple oral prednisone tablets. Besides, the prognosis and safety will be evaluated. The present study aims to evaluate the clinical efficacy, prognosis, and safety of electroacupuncture combined with oral prednisone tablets in the acute phase of IFP, using surface electromyography (sEMG) to objectively observe the recovery of facial expression muscle function. In addition, the morphological changes of the facial nerve were observed dynamically by magnetic resonance imaging (MRI) in the acute phase to reveal the effect mechanism of this therapy. Methods Randomized controlled trials will be conducted in the first teaching hospital of Tianjin University of Traditional Chinese Medicine in China from September 2020 to April 2021. The treatment will be carried out in two phases, including the acute phase and the recovery phase. Eighty IFP patients will be recruited and randomized into two groups with a 1:1 ratio. Subjects in the acute phases of the control group will be given oral prednisone tablets, based on the control group, and subjects of the experimental group will be given electroacupuncture therapy simultaneously in the acute phase. Both groups will be stopped taking prednisone tablets and turn to electroacupuncture therapy in a recovery phase. Patients in the experimental group will receive treatment at least 6 times in the acute phase and both groups will receive treatment 9 times in the recovery phase, and there will be a follow-up period of 15 days after the treatment. The primary outcome is supposed to be related to the changes observed in the Sunnybrook (Toronto) Facial Grading System (SFGS) on the baseline and day 30 after the onset. Secondary outcome measures will include House-Brackmann Facial Nerve Grading System (H-B), measurement of Numerical Rating Scale (NRS), Facial Disability Index scale (FDI, including physical function subscore, FDIP, and social functioning and well-being subscore, FDIS), surface electromyogram (sEMG), and magnetic resonance imaging (MRI). Adverse events will be recorded for safety assessment. Discussion The results of this trial will allow the present study to compare the difference in efficacy and prognosis between the strategy of combined electroacupuncture in the acute phase and only oral prednisone tablets. The findings from this trial will be published in peer-reviewed journals. Trial registration CHICTR ChiCTR2000038472 . Registered on 23 September 2020
Related Links	https://trialsjournal.biomedcentral.com/counter/pdf/10.1186/s13063-021-05632-8.pdf
Ending Page	12
Page Count	12
Starting Page	1
File Format	HTM / HTML
ISSN	17456215
DOI	10.1186/s13063-021-05632-8
Journal	Trials
Issue Number	1
Volume Number	22
Language	English
Publisher	BioMed Central
Publisher Date	2021-09-28
Access Restriction	Open
Subject Keyword	Medicine Public Health Biomedicine Statistics for Life Sciences Health Sciences Electroacupuncture Idiopathic facial palsy Acute phase Study protocol Medicine/Public Health
Content Type	Text
Resource Type	Article
Subject	Medicine Pharmacology (medical)
Journal Impact Factor	2/2023
5-Year Journal Impact Factor	2.1/2023

Sl.	Authority	Responsibilities	Communication Details
1	Ministry of Education (GoI), Department of Higher Education	Sanctioning Authority	https://www.education.gov.in/ict-initiatives
2	Indian Institute of Technology Kharagpur	Host Institute of the Project: The host institute of the project is responsible for providing infrastructure support and hosting the project	https://www.iitkgp.ac.in
3	National Digital Library of India Office, Indian Institute of Technology Kharagpur	The administrative and infrastructural headquarters of the project	Dr. B. Sutradhar bsutra@ndl.gov.in
4	Project PI / Joint PI	Principal Investigator and Joint Principal Investigators of the project	Dr. B. Sutradhar bsutra@ndl.gov.in Prof. Saswat Chakrabarti will be added soon
5	Website/Portal (Helpdesk)	Queries regarding NDLI and its services	support@ndl.gov.in
6	Contents and Copyright Issues	Queries related to content curation and copyright issues	content@ndl.gov.in
7	National Digital Library of India Club (NDLI Club)	Queries related to NDLI Club formation, support, user awareness program, seminar/symposium, collaboration, social media, promotion, and outreach	clubsupport@ndl.gov.in
8	Digital Preservation Centre (DPC)	Assistance with digitizing and archiving copyright-free printed books	dpc@ndl.gov.in
9	IDR Setup or Support	Queries related to establishment and support of Institutional Digital Repository (IDR) and IDR workshops	idr@ndl.gov.in

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial

Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial

Efficacy of electroacupuncture on acute abdomen emergency care: study protocol for a randomized controlled trial

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial

Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial

Effects of electroacupuncture therapy for Bell’s palsy from acute stage: study protocol for a randomized controlled trial

Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial

Efficacy and safety of electroacupuncture combined with Suanzaoren decoction for insomnia following stroke: study protocol for a randomized controlled trial

Efficacy evaluation and mechanism study of electroacupuncture intervention in acute phase of IFP: study protocol for a randomized controlled trial

Similar Documents

Efficacy of electroacupuncture for symptoms of menopausal transition: study protocol for a randomized controlled trial

Efficacy and safety of electroacupuncture for post stroke depression: study protocol for a randomized controlled trial

Efficacy of electroacupuncture on acute abdomen emergency care: study protocol for a randomized controlled trial

Electroacupuncture for insomnia disorder: study protocol for a randomized controlled trial

Electroacupuncture for pressure ulcer: a study protocol for a randomized controlled pilot trial

Effect of electroacupuncture on discomfort during gastroscopy: a study protocol for a randomized controlled trial

Effects of electroacupuncture therapy for Bell’s palsy from acute stage: study protocol for a randomized controlled trial

Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial

Efficacy and safety of electroacupuncture combined with Suanzaoren decoction for insomnia following stroke: study protocol for a randomized controlled trial

Efficacy evaluation and mechanism study of electroacupuncture intervention in acute phase of IFP: study protocol for a randomized controlled trial