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Turtle-probing needling guided by high frequency ultrasound for facial muscle inversion following facial paralysis inversion - a randomized controlled trial

注册号：

Registration number：

ITMCTR2025000783

最近更新日期：

Date of Last Refreshed on：

2025-04-17

注册时间：

Date of Registration：

2025-04-17

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

高频超声引导下苍龟探穴针法治疗面瘫后面肌倒错的随机对照试验

Public title：

Turtle-probing needling guided by high frequency ultrasound for facial muscle inversion following facial paralysis inversion - a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

高频超声引导下苍龟探穴针法治疗面瘫后面肌倒错的临床研究

Scientific title：

Turtle-probing needling guided by high frequency ultrasound for facial muscle inversion following facial paralysis inversion - a clinical 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：

2022MSXM155

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：

周源

研究负责人：

周源

Applicant：

Zhou yuan

Study leader：

Zhou yuan

申请注册联系人电话：

Applicant telephone：

18725827175

研究负责人电话：

Study leader's telephone：

18725827175

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：

328367865@qq.com

研究负责人电子邮件：

Study leader's E-mail：

328367865@qq.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：

重庆市江北区盘溪七支路六号

研究负责人通讯地址：

重庆市江北区盘溪七支路六号

Applicant address：

No.6 Seventh Branch Road Panxi Jiangbei District Chongqing China

Study leader's address：

No.6 Seventh Branch Road Panxi Jiangbei District Chongqing China

申请注册联系人邮政编码：

Applicant postcode：

400021

研究负责人邮政编码：

Study leader's postcode：

400021

申请人所在单位：

重庆市中医院

Applicant's institution：

Chongqing Hospital of Traditional Chinese Medicine

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：

2022-ky-36

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：

重庆市中医院伦理委员会

Name of the ethic committee：

Ethics Committee of Chongqing Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2022/6/15 0:00:00

伦理委员会联系人：

魏知

Contact Name of the ethic committee：

023-67630637

伦理委员会联系地址：

重庆市江北区盘溪七支路六号重庆市中医院GCP办公室

Contact Address of the ethic committee：

GCP Office Chongqing Hospital of Traditional Chinese Medicine No.6 Panxi Seven Branch Road Jiangbei District Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

023-67630637

伦理委员会联系人邮箱：

Contact email of the ethic committee：

cqszyyllwyh@163.com

研究实施负责（组长）单位：

重庆市中医院

Primary sponsor：

Chongqing Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

重庆市江北区盘溪七支路六号

Primary sponsor's address：

No.6 Seventh Branch Road Panxi Jiangbei District Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

重庆市

Country：

China

Province：

Chongqing

City：

Chongqing

单位(医院)：

重庆市中医院

具体地址：

重庆市江北区盘溪七支路六号

Institution
hospital：

Chongqing Hospital of Traditional Chinese Medicine

Address：

No.6 Seventh Branch Road Panxi Jiangbei District Chongqing

经费或物资来源：

重庆市科卫联合医学科研项目

Source(s) of funding：

Chongqing medical scientific research project (Joint project of Chongqing Health Commission and Science and Technology Bureau)

研究疾病：

面瘫

研究疾病代码：

Target disease：

facial paralysis

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

观察高频超声引导下苍龟探穴针法治疗面瘫后面肌倒错的临床疗效。

Objectives of Study：

To evaluate the clinical efficacy of Turtle-probing needling guided by high-frequency ultrasound in treating facial muscle inversion following facial paralysis.

药物成份或治疗方案详述：

采用临床随机对照试验方法，通过SAS软件产生的随机序列将60例患者按1:1的比例随机分为治疗组和对照组。治疗组采用苍龟探穴针法，对患侧提口角肌、降口角肌和降下唇肌中杨氏模量值异常增高点进行针刺，对照组以循经配合面部三线法选穴并行常规针刺，两组患者均每周治疗2次，连续治疗3周，共治疗6次。主要结局指标为治疗前后杨氏模量值的改善情况，次要结局指标为面神经功能分级标准（House-Brackmann，H-B）量表、面部残疾指数量表（Facial disability index，FDI）量表及有效率。

Description for medicine or protocol of treatment in detail：

Clinical randomized controlled trial method was used. 60 patients were randomly divided into treatment group and control group according to 1:1 ratio by random sequence generated by SAS software. In the treatment group we used Turtle-probing needling to acupuncture the abnormal points of increase of Young's modulus in the affected side levator anguli oris muscle the depressor anguli oris muscle and the depressor labii inferioris muscle. And in the control group acupuncture was performed by selecting acupoints according to meridians and facial three-line method. Both groups were treated twice a week for 3 consecutive weeks and 6 times in total. The primary outcome was the improvement of the Young's model before and after treatment. The secondary outcomes included the House-Brackmann (H-B) scale the Facial disability index (FDI) scale and the response rate.

纳入标准：

①符合诊断标准；②临床表现为面肌倒错者；③年龄16～75岁；④病程大于三个月；⑤均为单侧发病，面神经功能分级标准（House-Brackmann，H-B）分级为II级以上；⑥患者知情并自愿接受治疗。

Inclusion criteria

① Meet the diagnostic criteria; ② The clinical manifestations is facial muscle inversion; ③ Age 16-75 years old; ④ The course of the disease is greater than three months; (5) All patients had unilateral disease and the classification standard of facial nerve function (House-Brackmann H-B) was grade II or above; ⑥ Patients are informed and willing to receive treatment.

排除标准：

①面瘫假倒错；②双侧面瘫或中枢性面瘫；③手术、外伤、颅内病变及格林-巴利综合征导致的面瘫；④合并糖尿病、库欣综合征、中重度骨质疏松症、严重高血压病或严重精神病等；⑤严重的凝血功能障碍者；⑥妊娠或哺乳期妇女；⑦惧针或晕针的患者；⑧参与了其他临床研究的患者。

Exclusion criteria：

① False facial muscle inversion; ② Bilateral or central facial paralysis; ③ Facial paralysis caused by surgery trauma intracranial lesions and Guillain-Barre syndrome; (4) Combined with diabetes Cushing's syndrome moderate to severe osteoporosis severe hypertension or severe mental illness; ⑤ serious coagulation disorders; ⑥ Pregnant or lactating women;⑦Patients afraid of needles or fainting needles; ⑧ Patients participating in other clinical studies.

研究实施时间：

Study execute time：

从From 2022-01-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2022-07-01

至To      2023-05-31

干预措施：

Interventions：

组别：

治疗组

样本量：

30

Group：

The treatment group

Sample size：

干预措施：

采用苍龟探穴针法，对患侧提口角肌、降口角肌和降下唇肌中杨氏模量值异常增高点进行针刺

干预措施代码：

Intervention：

Turtle-probing needling was used to acupuncture the abnormal points of increase of Young's modulus in the affected side levator anguli oris muscle the depressor anguli oris muscle and the depressor labii inferioris muscle.

Intervention code：

组别：

对照组

样本量：

30

Group：

The control group

Sample size：

干预措施：

以循经取穴配合面部三线法取穴进行常规针刺

干预措施代码：

Intervention：

acupuncture was performed by selecting acupoints according to meridians and facial three-line method

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

重庆市

市(区县)：

重庆市

Country：

China

Province：

Chongqing province

City：

Chongqing

单位(医院)：

重庆市中医院

单位级别：

省级

Institution/hospital：

Chongqing Hospital of Traditional Chinese Medicine

Level of the institution：

provincial level

测量指标：

Outcomes：

指标中文名：

杨氏模量值

指标类型：

主要指标

Outcome：

Young's modulus of expression muscle

Type：

Primary indicator

测量时间点：

治疗前及治疗结束后

测量方法：

采用高频超声测量

Measure time point of outcome：

Before and after treatment

Measure method：

High frequency ultrasonic measurement

指标中文名：

面部残疾指数量表

指标类型：

次要指标

Outcome：

the Facial disability index (FDI) scale

Type：

Secondary indicator

测量时间点：

治疗前及治疗结束后

测量方法：

填写量表

Measure time point of outcome：

Before and after treatment

Measure method：

Fill in the scale

指标中文名：

面神经功能分级标准（H-B分级）

指标类型：

次要指标

Outcome：

the House-Brackmann (H-B) scale

Type：

Secondary indicator

测量时间点：

治疗前及治疗结束后

测量方法：

填写量表

Measure time point of outcome：

Before and after treatment

Measure method：

Fill in the scale

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

结束

Completed

年龄范围：

最小 16 岁
Min age years
最大 75 岁
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）：

通过SAS软件产生的随机序列将60例患者按1:1的比例随机分为治疗组和对照组。

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

The patients were randomly divided into treatment group and control group in a 1:1 ratio by SAS software

盲法：

由于两组干预方式差异过大，无法对操作者、受试者实行盲法，所以由不了解受试者情况的人员进行统计分析。并且在试 验过程中实行疗效评价者、操作者、统计分析人员三分离，以尽可能减小偏倚。

Blinding：

Since the intervention methods of the two groups were too different, it was impossible to blind the operators and subjects, so statistical analysis was carried out by personnel who did not know the conditions of the subjects. In order to minimize bias, the evaluators, operators and statistical analysts were separated during the trial.

是否共享原始数据：

IPD sharing：

是

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）：

本研究产生和使用的数据将按照法律和道德要求提供

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

The data generated from our research and used in this study will be made accessible in accordance with the legal and ethical requirements.

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：

数据采集：由专业医生填写FDI、HB量表，杨氏模量值均由同一经验丰富的操作者通过高频超声仪器读取并记录，操作过程及方法一致，尽可能减小认为误差。 数据管理：由两名专门的数据录入人员将CRF表中的数据录入EXCEL表格，由双人独立录入，交叉验证纠错，数据备份并管理访问权限，由统计分析人员进行数据分析。

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

Data collection: The FDI and HB scales are filled in by professional doctors and the Young's modulus values are read and recorded by the same experienced operator through the high-frequency ultrasound instrument with the same operation process and method to minimize the perceived error. Data management: Two dedicated data entry personnel will enter the data in the CRF table into the EXCEL table and the data will be independently entered by two people cross-verification and error correction data backup and access management and data analysis will be carried out by statistical analysts.

数据管理委员会：

Data Managemen Committee：

无

No

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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