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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000157
Enrollment
Unknown
Registered
2024-08-01
Start date
2024-08-15
Completion date
Unknown
Last updated
2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

migraine

Interventions

Non meridian acupoint embedding group:Non meridian acupoint embedding
Placebo napex acupoint catgut embedding therapy group :Placebo napex acupoint catgut embedding therapy
Napex acupoint catgut embedding therapy group:Napex acupoint catgut embedding therapy
Healthy control group:None
Placebo non meridian acupoint embedding group:Placebo non meridian acupoint embedding

Sponsors

Nanjing Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1) Meet the diagnostic criteria of migraine without aura; 2) Patients 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; 3) No migraine preventive treatment including acupuncture and drugs in the past 1 month; 4) Not taking psychoactive or vasoactive drugs in the last 3 months; 5) No long-term habit of taking analgesic drugs; 6) Patients voluntarily receive preventive treatment and sign informed consent forms.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
frequency of headache attacks;the number of headache attack days;

Secondary

MeasureTime frame
headache severity;amplitude of low frequency fluctuation,ALFF;Migraine specific Quality of Life questionnaire;the improved response rate by 50%;

Countries

China

Contacts

Public ContactRenzhong Kou

Nanjing Hospital of Traditional Chinese Medicine

530950775@qq.com15861813731

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026