Acupuncture for Bell's Palsy: Clinical Outcomes from a Real-World Study

注册号:

Registration number:

ITMCTR2025000932

最近更新日期:

Date of Last Refreshed on:

2025-05-08

注册时间:

Date of Registration:

2025-05-08

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

针刺治疗特发性面神经麻痹临床疗效的真实世界研究

Public title:

Acupuncture for Bell's Palsy: Clinical Outcomes from a Real-World Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺治疗特发性面神经麻痹临床疗效的真实世界研究

Scientific title:

Acupuncture for Bell's Palsy: Clinical Outcomes from a Real-World Study

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

申请注册联系人:

潘婷

研究负责人:

白鹏

Applicant:

Ting Pan

Study leader:

Peng Bai

申请注册联系人电话:

Applicant telephone:

17318289392

研究负责人电话:

Study leader's telephone:

18801283507

申请注册联系人传真 :

Applicant Fax:

研究负责人传真:

Study leader's fax:

申请注册联系人电子邮件:

Applicant E-mail:

pttcm2020@163.com

研究负责人电子邮件:

Study leader's E-mail:

baipeng202305@163.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

研究负责人网址(自愿提供):

Study leader's website
(voluntary supply):

申请注册联系人通讯地址:

北京市朝阳区北三环东路11号

研究负责人通讯地址:

北京市朝阳区北三环东路11号

Applicant address:

11 North Third Ring East Road Chaoyang District Beijing

Study leader's address:

11 North Third Ring East Road Chaoyang District Beijing

申请注册联系人邮政编码:

Applicant postcode:

100029

研究负责人邮政编码:

Study leader's postcode:

100029

申请人所在单位:

北京中医药大学第三附属医院

Applicant's institution:

Beijing University of Chinese Medicine Third Affiliated Hospital

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024DZMEC-511-01

伦理委员会批件附件:

Approved file of Ethical Committee:

View

批准本研究的伦理委员会名称:

北京中医药大学东直门医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/11/14 0:00:00

伦理委员会联系人:

韩雪婷

Contact Name of the ethic committee:

Tingxue Han

伦理委员会联系地址:

北京市东城区海运仓5号

Contact Address of the ethic committee:

No.5 Haiyuncang Dongcheng District Beiiing China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 01084012709

伦理委员会联系人邮箱:

Contact email of the ethic committee:

dzmyyec@126.com

研究实施负责(组长)单位:

北京中医药大学东直门医院

Primary sponsor:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

研究实施负责(组长)单位地址:

北京市东城区海运仓5号

Primary sponsor's address:

No.5 Haiyuncang Dongcheng District Beiiing China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京

市(区县):

北京市

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京中医药大学东直门医院

具体地址:

北京市东城区海运仓5号

Institution
hospital:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Address:

No.5 Haiyuncang Dongcheng District Beiiing China

经费或物资来源:

国家中医药管理局青年岐黄学者项目

Source(s) of funding:

Qi Huang Young Scholars Program of the National Administration of Traditional Chinese Medicine

研究疾病:

特发性面神经麻痹

研究疾病代码:

Target disease:

Bell's Palsy

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

队列研究

Cohort study

研究所处阶段:

Study phase:

其它

Others

研究目的:

真实世界中针刺治疗特发性面神经麻痹的影响因素及针刺治疗特发性面神经麻痹的有效性和安全性。

Objectives of Study:

Influencing factors of acupuncture treatment for Bell's Palsy in the real world as well as the effectiveness and safety of acupuncture treatment for Bell's Palsy.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)符合 Bell 麻痹诊断标准; (2)年龄≥18 岁; (3)病程在 2 周以内; (4)干预措施参考《循证针灸临床实践指南·贝尔麻痹(修订版)》中针灸治疗和推荐方案;主穴选用患侧地仓、颊车、阳白、下关;对症配穴:头痛:太阳;皱额、蹙眉差:攒竹、丝竹空;眼睑闭合不全:睛明、瞳子髎、鱼腰;耸鼻不能:迎香;人中沟歪斜:水沟;颏唇沟歪斜:承浆;示齿不能:巨髎;耳鸣、耳聋:听会;乳突部压痛:翳风、风池;具体选穴由临床医生决定。 (5)当前治疗次数≥3 次;

Inclusion criteria

(1) Meet the diagnostic criteria for Bell's Palsy. (2) Age ≥ 18 years old. (3) The course of the disease is within 2 weeks. (4) The intervention measures refer to the acupuncture treatment and recommended protocols in the Evidence - Based Acupuncture Clinical Practice Guidelines for Bell's Palsy (Revised Edition). The main acupoints selected are Dicang (ST4) Jiache (ST6) Yangbai (GB14) and Xiaguan (ST7) on the affected side. Symptom - based acupoint selection: For headache: Taiyang (EX - HN5); for poor forehead wrinkling and frowning: Cuanzhu (BL2) Sizhukong (SJ23); for incomplete eyelid closure: Jingming (BL1) Tongziliao (GB1) Yuyao (EX - HN4); for inability to flare the nostrils: Yingxiang (LI20); for deviation of the philtrum: Shuigou (GV26); for deviation of the mental cleft: Chengjiang (CV24); for inability to show teeth: Juliao (ST3); for tinnitus and deafness: Tinghui (GB2); for mastoid tenderness: Yifeng (SJ17) Fengchi (GB20). The specific acupoint selection shall be determined by the clinician. (

排除标准:

(1)因神智原因无法正常沟通者; (2)患者在患病期间经由不同职称的针灸医生治疗。

Exclusion criteria:

(1) Those who are unable to communicate normally due to mental status reasons. (2) The patient was treated by acupuncturists with different professional titles during the illness.

研究实施时间:

Study execute time:

From 2023-03-01

To      2025-06-30

征募观察对象时间:

Recruiting time:

From 2024-11-14

To      2025-06-30

干预措施:

Interventions:

组别:

电针联合穴位注射组

样本量:

50

Group:

The electroacupuncture combined with acupoint injection group

Sample size:

干预措施:

单纯针刺、电针、穴位注射联合治疗

干预措施代码:

Intervention:

Acupuncture electroacupuncture and acupoint injection used in combination

Intervention code:

组别:

单纯针刺组

样本量:

100

Group:

The simple acupuncture group

Sample size:

干预措施:

单纯针刺治疗

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

电针组

样本量:

50

Group:

The good prognosis group

Sample size:

干预措施:

The electroacupuncture group

干预措施代码:

Intervention:

Acupuncture

Intervention code:

样本总量 Total sample size : 200

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

北京市

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

北京中医药大学东直门医院

单位级别:

三甲

Institution/hospital:

Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

神经电图

指标类型:

主要指标

Outcome:

Nerve Electrography

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑自评量表

指标类型:

次要指标

Outcome:

Self-Rating Anxiety Scale (SAS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表

指标类型:

次要指标

Outcome:

Self-Rating Depression Scale (SDS)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医生命质量评价量表

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Quality of Life Scale (CD-11D)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

面部评价量表

指标类型:

次要指标

Outcome:

Facial Clinimetric Evaluation Scale (FaCE)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

面部残疾指数

指标类型:

次要指标

Outcome:

Facial Disability Index (FDI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

House-Brackmann面神经功能分级量表

指标类型:

主要指标

Outcome:

The House-Brackmann Facial Nerve Grading Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

痊愈时间

指标类型:

次要指标

Outcome:

Recovery Time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Sunnybrook评分

指标类型:

次要指标

Outcome:

Sunnybrook Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌电图

指标类型:

主要指标

Outcome:

Electromyography

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 100
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

非随机对照试验,为观察性研究

Randomization Procedure (please state who generates the random number sequence and by what method):

Non-randomized controlled trial is an observational study.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

通过发表论文共享

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Share data by publishing papers.

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Electronic data capture

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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