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Clinical study on the treatment of intractable facial paralysis by special acupuncture and moxibustion by Professor Yang Jun

Registration number：

ITMCTR2200006743

Date of Last Refreshed on：

2022-11-04

Date of Registration：

2022-11-04

Registration Status：

Prospective registration

Public title：

Clinical study on the treatment of intractable facial paralysis by special acupuncture and moxibustion by Professor Yang Jun

English Acronym：

Scientific title：

Clinical study on the treatment of intractable facial paralysis by special acupuncture and moxibustion by Professor Yang Jun

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065442 ; ChiMCTR2200006743

Applicant：

Aihong yuan

Study leader：

Aihong yuan

Applicant telephone：

15395001068

Study leader's telephone：

15395001068

Applicant Fax：

Study leader's fax：

Applicant E-mail：

490603279@qq.com

Study leader's E-mail：

490603279@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

117 Meishan Road, Shushan District, Hefei, Anhui Province, China

Study leader's address：

117 Meishan Road, Shushan District, Hefei, Anhui Province, China

Applicant postcode：

Study leader's postcode：

Applicant's institution：

The First Affiliated Hospital of Anhui University 0f Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

2022AH-79

Approved file of Ethical Committee：

View

Name of the ethic committee：

Medical Ethics Committee of the First Afiliated Hospital of Anhui University of Traditional Chinese Medicine

Date of approved by ethic committee：

2022/10/31 0:00:00

Contact Name of the ethic committee：

Guiqin Xu

Contact Address of the ethic committee：

117 Meishan Road, Shushan District, Hefei, Anhui, China

Contact phone of the ethic committee：

+86 551 62838532

Contact email of the ethic committee：

Primary sponsor：

The First Affiliated Hospital of Anhui University 0f Chinese Medicine

Primary sponsor's address：

117 Meishan Road, Shushan District, Hefei, Anhui, China

Secondary sponsor：

Country：

China

Province：

Anhui

City：

Hefei

Institution
hospital：

The First Affiliated Hospital of Anhui University 0f Chinese Medicine

Address：

117 Meishan Road, Shushan District, Hefei, Anhui Province, China

Source(s) of funding：

Anhui Acupuncture Clinical Medical Research Center open fund project

Target disease：

Intractable facial paralysis

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Through the Anzhong Fine Scale of Facial palsy, the H-B scale and Sunnybrook (Toronto) Facial palsy grading system were compared. The efficacy and safety of Professor Yang Jun's special acupuncture and moxibustion method in the treatment of intractable facial palsy were evaluated by combining surface electromyography and infrared thermal imaging, and the effectiveness and superior effectiveness of the treatment were confirmed and promoted.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

1. Meet the diagnostic criteria of Bell's facial paralysis; 2. Patients with unilateral Bell's facial paralysis whose disease course ≥ 3 months; 3. The patient has normal mental behavior and no other serious diseases; 4. Those who sign the informed consent of the experiment voluntarily and can cooperate with and adhere to acupuncture treatment.

Exclusion criteria：

1. Failure to meet the diagnostic criteria for Bell's facial paralysis; 2. Patients with disease duration <2 months or bilateral simultaneous facial paralysis; 3. Chronic diseases such as severe hypertension, diabetes or mental illness; 4. Lactating, gestational and pregnant women; 5. Poor compliance to the experiment and failure to complete the experiment.

Study execute time：

From 2022-10-31

To      2023-12-31

Recruiting time：

From 2022-10-31

To      2023-12-31

Interventions：

30

Group：

Control group

Sample size：

Intervention：

Routine treatment with ordinary acupuncture

Intervention code：

30

Group：

experimental group

Sample size：

Intervention：

Professor Yang Jun's characteristic technique in the treatment of intractable facial paralysis

Intervention code：

Total sample size ： 60

Countries of recruitment
and research settings：

Country：

China

Province：

Anhui

City：

Hefei

Institution/hospital：

The First Affiliated Hospital of Anhui University 0f Chinese Medicine

Level of the institution：

Tertiary A

Outcomes：

Outcome：

Anhui University of Chinese Medicine Facial paralysis fine scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Infrared thermal camera

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Methods of electricity

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

H-B Grading scale

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Sunnybrook (Toronto) Facial Nerve Assessment System table

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

none

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

1
Min age years
100
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The random number table method

Blinding：

IPD sharing：

No

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

none

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

1) Fill in the case record form. 2) Data is uploaded to ResMan system.

Data Managemen Committee：

No

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

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