Discussion on the Mechanism of Acupuncture on Patients with Paroxysmal Migraine Without Aura : a Randomized Controlled Clinical Trial

Bo Huang

Status: Invitation-only

Conditions: Migraine, Dysmenorrhea

Treatments: Other: sham acupuncture; Other: real acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT06676670

2021MWOATJ01

Details and patient eligibility

About

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.

Enrollment: 108 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

real acupuncture group

Experimental group

Description:

1. The patient immediately received acupuncture treatment and imaging scan on the scanning bed (acupuncture and imaging scan at the same time). Acupuncture left Hegu point to promote qi. Axial T2WI imaging for 48 seconds, fMR-BOLD imaging for 8 minutes and 11 seconds, and ASL imaging for 6 minutes and 03 seconds were simultaneously collected during acupuncture. The scanning time of each sequence was divided into 4 time periods, each time period was 1 time, each scanning sequence was 4 times, each time was 10 seconds, and the duration of acupuncture was 15 minutes and 02 seconds. 2. After acupuncture withdrawal, axial T2WI imaging was repeated for 48 seconds, fMRI-Bold imaging for 8 minutes and 11 seconds, and ASL imaging for 6 minutes and 03 seconds.

Treatment:

Other: real acupuncture

sham acupuncture group

Sham Comparator group

Description:

Control group (false acupuncture group) 1. Axial imaging of DWI was performed before the patient underwent pseudoacupuncture (12 minutes 08 seconds). 2. The patient immediately underwent a sham acupuncture and imaging scan on the scanning bed (the sham acupuncture and imaging scan were performed simultaneously). Pseudoacupuncture left Hegu point. DWI axial imaging (12 minutes 08 seconds) was collected synchronously during the fake acupuncture. The scanning time during the fake acupuncture was divided into 4 time periods, with 1 needle in each time period, 4 needles in each time period, each time for 10 seconds, and the duration of the fake acupuncture was 12 minutes 08 seconds. 3. Axial DWI imaging was repeated (12 minutes and 08 seconds) after acupuncture withdrawal.

Treatment:

Other: sham acupuncture

healthy controls

No Intervention group