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Clinical study and brain fMRI mechanism of "Napex acupoint catgut embedding therapy" in the treatment of migraine without aura

Registration number：

ITMCTR2024000157

Date of Last Refreshed on：

2024-08-01

Date of Registration：

2024-08-01

Registration Status：

Prospective registration

Public title：

Clinical study and brain fMRI mechanism of "Napex acupoint catgut embedding therapy" in the treatment of migraine without aura

English Acronym：

Scientific title：

Clinical study and brain fMRI mechanism of "Napex acupoint catgut embedding therapy" in the treatment of migraine without aura

Scientific title acronym：

Study subject ID：

The registration number of the Partner Registry or other register：

Applicant：

Renzhong Kou

Study leader：

Renzhong Kou

Applicant telephone：

15861813731

Study leader's telephone：

15861813731

Applicant Fax：

Study leader's fax：

Applicant E-mail：

530950775@qq.com

Study leader's E-mail：

530950775@qq.com

Study leader's website(voluntary supply)：

Study leader's website
(voluntary supply)：

Applicant address：

157 Daming Road, Nanjing, JiangsuProvince

Study leader's address：

157 Daming Road, Nanjing, Jiangsu Province

Applicant postcode：

Study leader's postcode：

Applicant's institution：

Nanjing Hospital of Traditional Chinese Medicine

Approved by ethic committee：

Approved No. of ethic committee：

KY2024047

Approved file of Ethical Committee：

View

Name of the ethic committee：

EEthics Committee of Nanjing Hospital of Traditional Chinese Medicine

Date of approved by ethic committee：

2024/7/4 0:00:00

Contact Name of the ethic committee：

Desong Kong

Contact Address of the ethic committee：

157 Daming Road, Nanjing, JiangsuProvince

Contact phone of the ethic committee：

02552276505

Contact email of the ethic committee：

kongds@njucm.edu.cn

Primary sponsor：

Nanjing Hospital of Traditional Chinese Medicine

Primary sponsor's address：

157 Daming Road, Nanjing, JiangsuProvince

Secondary sponsor：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution
hospital：

Nanjing Hospital of Traditional Chinese Medicine

Address：

157 Daming Road, Nanjing, JiangsuProvince

Source(s) of funding：

2023 Nanjing Health science and technology development special fund project

Target disease：

migraine

Target disease code：

Study type：

Interventional study

Study design：

randomized controlled trial(parallel group design)

Study phase：

Others

Objectives of Study：

Preliminary clinical observation shows that the team's original "occipito-nuchal embedding method" is effective and safe in the prevention and treatment of migraine, but it needs to be verified by strictly designed randomized controlled studies, and its potential effect mechanism is still unclear. Therefore, this study intends to conduct a randomized controlled study on the efficacy and safety of "occipito-nuchal embedding method" in the preventive treatment of migraine without aura, and explore its brain fMRI effect mechanism, so as to provide clinical basis for further promoting "occipito-nuchal embedding method" in the prevention and treatment of migraine, and provide evidence for explaining its effect mechanism.

Description for medicine or protocol of treatment in detail：

Inclusion criteria

①Meet the diagnostic criteria of migraine without aura; ②Patients aged between 18 and 65 years old, with a course of more than 6 months and an average of more than 2 headache episodes per month; ③No migraine preventive treatment including acupuncture and drugs in the past 1 month; ④Not taking psychoactive or vasoactive drugs in the last 3 months; ⑤No long-term habit of taking analgesic drugs; ⑥Patients voluntarily receive preventive treatment and sign informed consent forms.

Exclusion criteria：

①The type of headache other than migraine without aura was consistent with ICHD-3; ②There are organic lesions such as tumors, inflammation, degenerative diseases, etc. ③Combined with severe neurological, cardiovascular, digestive, urinary, hematological, endocrine system diseases unrelated to migraine; ④Pregnant and lactating women; ⑤Have a serious mental disorder or cognitive impairment that prevents them from communicating properly and receiving medical treatment; ⑥Suspected or confirmed history of alcohol or drug abuse. ⑦ Have contraindications to MRI examination such as metal implants in the body and claustrophobia; ⑧Have severe asymmetric head anatomical structure or clear lesions found in MRI examination.

Study execute time：

From 2024-08-15

To      2026-12-31

Recruiting time：

From 2024-08-15

To      2026-12-31

Interventions：

33

Group：

Non meridian acupoint embedding group

Sample size：

Intervention：

Non meridian acupoint embedding

Intervention code：

33

Group：

Placebo napex acupoint catgut embedding therapy group

Sample size：

Intervention：

Placebo napex acupoint catgut embedding therapy

Intervention code：

33

Group：

Napex acupoint catgut embedding therapy group

Sample size：

Intervention：

Napex acupoint catgut embedding therapy

Intervention code：

10

Group：

Healthy control group

Sample size：

Intervention：

None

Intervention code：

33

Group：

Placebo non meridian acupoint embedding group

Sample size：

Intervention：

Placebo non meridian acupoint embedding

Intervention code：

Total sample size ： 142

Countries of recruitment
and research settings：

Country：

China

Province：

Jiangsu

City：

Nanjing

Institution/hospital：

Nanjing Hospital of Traditional Chinese Medicine

Level of the institution：

3

Outcomes：

Outcome：

headache severity

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

amplitude of low frequency fluctuation,ALFF

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

Safety evaluation

Type：

Adverse events

Measure time point of outcome：

Measure method：

Outcome：

frequency of headache attacks

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

Migraine specific Quality of Life questionnaire

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Outcome：

the number of headache attack days

Type：

Primary indicator

Measure time point of outcome：

Measure method：

Outcome：

the improved response rate by 50%

Type：

Secondary indicator

Measure time point of outcome：

Measure method：

Collecting sample(s)
from participants：

Not yet recruiting

18
Min age years
65
Max age years

Recruiting status：

Participant age：

Gender：

Both

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

The SPSS22.0 software gives random numbers

Blinding：

IPD sharing：

No

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

/

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

CRF

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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