A Randomized Controlled Trial of Acupuncture in Treating Migraine

Phase

N/A

Condition

Oral Facial Pain

Migraine (Adult)

Migraine (Pediatric)

Treatment

N/A

Clinical Study ID

NCT04766762

2020ZB125

Ages 25-50
All Genders

Study Summary

Migraine without aura is a common kind of nervous system diseases that can easily cause recurrent headache, leading to severe impacts on quality of life and health care costs. Current therapeutic options for migraine without aura mainly include flunarizine hydrochloride that can relieve vasospasm. Nevertheless, the efficacy of flunarizine hydrochloride is always limited by inevitable side effects, which result in poor compliance of patients. Moreover, for some most suffering patients, the control of pain is often unsatisfactory despite of the administration of complex treatment combinations.

As a non-pharmaceutical therapy, acupuncture is widely used for a wide range of pain conditions. Thus, it might be an alternative treatment for migraine without aura. The aim of this randomized controlled trial is to investigate the efficacy and safety of acupuncture therapy in patients with migraine without aura from the perspective of Regulating Ying and Wei.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patients meet the diagnostic criteria of migraine without aura;
25 ≤ age ≤50 years, male or female;
The efficacy of drugs and other therapeutic methods is not obvious; the frequency ofmigraine attacks in the past 3 months is more than twice a month;
Drug treatment for migraine without aura is stopped for at least one week;
Participants can understand the study protocol and written informed consent is signed.

Exclusion

Exclusion Criteria:

Patients have severe complications in cardiovascular, liver, kidney, hematopoietic andother systems;
Pregnant or lactating women;
Patients have spontaneous bleeding tendency so it is not suitable for them to receiveacupuncture;
Patients have an allergic history of flunarizine hydrochloride or a history ofdepression;
Patients are diagnosed as psychosis.

Study Design

April 21, 2021

February 28, 2023

Study Description

This randomized controlled trial will enroll 96 migraine patients without aura from the Third Affiliated Hospital of Zhejiang Chinese Medical University. All patients will be randomly assigned to either the acupuncture combined with placebo group or sham acupuncture combined with medication group through a randomization system. Primary outcome will be pain intensity assessed by visual analogue scale (VAS) scale. Secondary outcomes will include migraine-specific quality of life (MSQOL) scale and headache needs assessment survey (HANA) questionnaire scale.

Connect with a study center

The Third Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang 310000
China
Active - Recruiting

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