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

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.

Conditions

• Migraine, Dysmenorrhea

Interventions

OTHER

real acupuncture

Real Acupuncture Group Main acupoints: Hegu (bilateral), Taichong (bilateral), Taiyang (unilateral), shuogu (unilateral), Fengchi (unilateral); Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning Operation method: supine position, skin routine disinfection. The special model of acupuncture and moxibustion (0.30mm × 30mm), fix the gasket on the acupoint skin with seam free tape, and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept for 30 minutes. During this period, the technique of small amplitude uniform lifting, inserting and twisting (3 times) will be performed every 10 minutes. A total of four times of needling will be performed.

OTHER

sham acupuncture

Sham acupuncture group Acupoint selection: select eight stimulation points at the neck and shoulder. Stimulation point 1: the midpoint of the line between the shoulder well and the giant bone (both sides); Stimulation point 2: 5 inches (both sides) of the inferior paraspinal process of the seventh thoracic vertebra; Stimulus point 3: the inferior paraspinal process of the eighth thoracic vertebra will be opened 5 inches (bilateral); Stimulus point 4: 5 inches (both sides) of the infraspinous process of the ninth thoracic vertebra. Positioning: refer to the 2006 national standard of the people's Republic of China (gb/t 12346-2006) acupoint names and positioning to avoid acupoints. Operation method: supine position, skin routine disinfection. Streitberger acupuncture (0. 300×30mm). Fix the gasket on the acupoint skin with seam free tape,and then acupuncture. After acupuncture, each acupoint will be lifted, inserted and twisted three times in small amplitude; The needle will be kept fo

Sponsors & Collaborators

• Bo Huang

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-19

Primary Completion

2026-02-19

Completion

2026-05-31

Countries

• China

Study Locations