Clinical trial NCT06676670: Discussion on the Mechanism of Acupuncture on Patients with Paroxysmal Migraine Without Aura : a Randomized Controlled Clinical Trial
Official title: Huazhong University of Science and Technology
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Migraine, Dysmenorrhea
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Migraine is common but poorly managed with drugs. Acupuncture, a non-pharmacological approach, has shown promise, yet its mechanisms remain unclear. This study aims to assess the efficacy and specificity of acupuncture for acute paroxysmal migraine without aura.

Methods: A randomized, single-blind, sham-controlled trial will recruit 60 patients from Tongji Hospital, China. Patients will receive 20 sessions of Deqi or sham acupuncture over 4 weeks and be followed for 8 weeks. Treatments will occur twice within 4 hours of headache onset. Primary outcome is complete headache remission within 120 minutes after two treatments without analgesics. Secondary outcomes include headache intensity reduction, remission rates, and adverse events. Blind assessment will be conducted after at least one session. Data will be analyzed using full and per-protocol sets.

Ethics: Approved by the Clinical Trial Ethics Committee (approval no: TJ-IRB20220573). Written consent will be obtained. Results will be published in a peer-reviewed journal.


Eligibility criteria: Inclusion Criteria:

* 1\\They met the diagnostic criteria of migraine without aura and had a history ofmore than 1 year; 2\\Age 18-65 years old;

  * 18.5kg/m2 ≤ BMI ≤ 30.0kg / m2,right-handed; ④ The average frequency of migraine attacks in recent 6 months was ≥ 2-8 times per month; The average number of migraine attacks per month in recent 6 months was less than 15 days; The neurological examination was negative, and the CT or MRI of the head was normal; There was no experience of acupuncture or migraine prevention and treatment in recent 3 months; Able to complete the baseline migraine diary; Agree to sign the informed consent form.

Exclusion Criteria:

* Other types of primary headache or secondary headache; It is complicated with serious primary diseases such as cardiovascular,cerebrovascular, liver, kidney, gastrointestinal, blood, nervous system, etc; Complicated with severe mental illness; In the past 12 weeks, migraine drugs were taken orally or headache treatment methods such as acupuncture and physiotherapy were received; Lactation, pregnant women and planned pregnant women; Participate in another clinical trial at the same time; Illiterate, unable to read comprehension scale; Poor compliance.

Primary outcomes:
measure: Proportion of people with complete remission of migraine
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: WuHan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study officials:
References: