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Clinical Study on the Treatment of Chronic Myogenic Temporomandibular Joint Pain with Acupuncture Therapy of

Registration number：

ITMCTR2200006782

Date of Last Refreshed on：

2022-11-15

Date of Registration：

2022-11-15

Registration Status：

Prospective registration

Public title：

Clinical Study on the Treatment of Chronic Myogenic Temporomandibular Joint Pain with Acupuncture Therapy of

English Acronym：

Scientific title：

Clinical Study on the Treatment of Chronic Myogenic Temporomandibular Joint Pain with Acupuncture Therapy of

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

ChiCTR2200065779 ; ChiMCTR2200006782

Applicant：

Li Jiacun

Study leader：

Yang Fan

Applicant telephone：

18681885795

Study leader's telephone：

13572486228

Applicant Fax：

Study leader's fax：

Applicant E-mail：

417323727@qq.com

Study leader's E-mail：

yangfan@fmmu.edu.cn

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

Bo'ai Kangju community, Hansen Road, Xincheng District, Xi'an City, Shaanxi Province

Study leader's address：

Air Force Military Medical University, Xincheng District, Xi'an, Shaanxi Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Dental Hospital of Air Force Military Medical University

Approved by ethic committee：

Approved No. of ethic committee：

IRB-REV-2022078

Approved file of Ethical Committee：

View

Name of the ethic committee：

Ethics Committee of Dental Hospital of the Fourth Military Medical University of the People's&

Date of approved by ethic committee：

2022/8/15 0:00:00

Contact Name of the ethic committee：

Contact Address of the ethic committee：

Contact phone of the ethic committee：

Contact email of the ethic committee：

Primary sponsor：

Dental Hospital of Air Force Military Medical University

Primary sponsor's address：

No. 145, Changle West Road, Xi'an, Shaanxi Province

Secondary sponsor：

Country：

China

Province：

Shaanxi Province

City：

Xi'an City

Institution
hospital：

Dental Hospital of Air Force Military Medical University

Address：

No. 145, Changle West Road, Xi'an, Shaanxi Province

Source(s) of funding：

Supported by the special project of the National Clinical Research Center for oral diseases of the Air Force Military Medical University of the people's Liberation Army of China

Target disease：

Temporomandibular joint disorders

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Phase I clinical trial

Objectives of Study：

Under the guidance of TMJ's "biaxial" etiology theory, the acupuncture therapy of "body and mind treating together" was developed to treat chronic myogenic TMJ pain. The system was scientifically and standardized through efficacy observation, and a standardized diagnosis and treatment process was established. The clinical experience was expanded and applied to TMJ pain treatment, providing new treatment ideas for TMJ pain treatment

Description for medicine or protocol of treatment in detail：

Inclusion criteria

① Patients aged 18 to 60 (inclusive) ② In accordance with the diagnostic criteria established in this study: a. MRI examination showed no other organic and structural lesions; b. The tenderness of masticatory muscles (temporalis, masseter, medial pterygoid and lateral pterygoid muscles) was positive by palpation. The pain VAS (0-10 points) was used for evaluation. The pain was ≥ 3 points, and the pain recurred for more than 1 year, including static and dynamic pain evaluation; c. Patients with chronic myogenic TMJ pain accompanied by anxiety were scored ≥ 14 (total score 29) with Hamilton Anxiety Scale and ≥ 16 with Sleep Scale. ③ Those who volunteer to receive treatment and sign the informed consent form ④ No other clinical researchers

Exclusion criteria：

① MRI examination of patients with organic diseases or severe bleeding prone diseases ② Pregnant or lactating women or mental patients ③ Patients cannot cooperate or are participating in other clinical researchers ④ Patients with severe heart diseases such as acupuncture contraindications, AS syndrome, third degree atrioventricular block, and frequent atrial fibrillation ⑤ Patients with severe allergic and infectious skin diseases

Study execute time：

From 2022-12-01

To      2024-12-31

Recruiting time：

From 2022-12-01

To      2024-10-01

Interventions：

500

Group：

control group

Sample size：

Intervention：

Occlusal plate+ Cognitive Therapy

Intervention code：

500

Group：

Experimental group 1

Sample size：

Intervention：

Acupuncture method for selecting points based on syndrome differentiation of somatic pain axis

Intervention code：

500

Group：

Experimental group 3

Sample size：

Intervention：

Acupuncture method for selecting points based on syndrome differentiation of somatic pain axis and psychological axis

Intervention code：

500

Group：

Experimental group 2

Sample size：

Intervention：

Acupuncture at points selected according to syndrome differentiation of somatic pain axis plus pseudo acupuncture at non meridian and non acupoint of psychological axis

Intervention code：

Total sample size ： 2000

Countries of recruitment
and research settings：

Country：

China

Province：

Shaanxi Province

City：

Xi'an City

Institution/hospital：

Dental Hospital of Air Force Military Medical University

Level of the institution：

Grade III Grade A

Outcomes：

Outcome：

VAS score of pain degree

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Sample Name：

nothing

Tissue：

Fate of sample 

Destruction after use

Note：

Not yet recruiting

18
Min age years
60
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

Randomized grouping with envelope method by Dr. Li Jiacun

Blinding：

IPD sharing：

No

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

Don't share

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

Including outpatient electronic case, image snow examination, evaluation scale, follow-up form, etc

Data Managemen Committee：

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

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