A Randomized Controlled Trial of Acupuncture in Treating Migraine

Not Applicable

• Conditions: Migraine Without Aura
• Interventions: Procedure: Acupuncture combined with placebo; Procedure: Sham acupuncture combined with flunarizine hydrochloride

• Registration Number: NCT04766762
• Lead Sponsor: The Third Affiliated hospital of Zhejiang Chinese Medical University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-02-17
• Study First Submitted QC: 2021-02-22
• Study First Posted: 2021-02-23
• Study Start: 2021-04-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-08
• Last Update Posted: 2022-07-11
• Primary Completion: 2023-01-01
• Study Completion: 2023-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

1. Patients meet the diagnostic criteria of migraine without aura;
2. 25 ≤ age ≤50 years, male or female;
3. The efficacy of drugs and other therapeutic methods is not obvious; the frequency of migraine attacks in the past 3 months is more than twice a month;
4. Drug treatment for migraine without aura is stopped for at least one week;
5. Participants can understand the study protocol and written informed consent is signed.

Exclusion Criteria

1. Patients have severe complications in cardiovascular, liver, kidney, hematopoietic and other systems;
2. Pregnant or lactating women;
3. Patients have spontaneous bleeding tendency so it is not suitable for them to receive acupuncture;
4. Patients have an allergic history of flunarizine hydrochloride or a history of depression;
5. Patients are diagnosed as psychosis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture combined with placebo group	Acupuncture combined with placebo	Patients in this group will receive acupuncture combined with placebo.
Sham acupuncture combined with medication group	Sham acupuncture combined with flunarizine hydrochloride	Participants in this group will receive sham acupuncture plus flunarizine hydrochloride.

Primary Outcome Measures

Name	Time	Method
Change in number of migraine attacks per 4 weeks	Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting	Change in Number of migraine attacks is assessed by patients' pain diary
Change in pain intensity	Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting	Change in Pain intensity will be measured by visual analog scale (VAS)，he VAS divides the pain from 0 to 10 into 11 grades. 0: No pain; 10: the worst pain; ≤3: mild pain; 4-6: moderate pain which is tolerable; 7-10: severe pain which is unbearable.

Secondary Outcome Measures

Name	Time	Method
Headache Needs Assessment Survey (HANA) Questionnaire Scale	Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting	Evaluate the frequency and severity of the migraine effect.The overall score ranges from 14 to 70, with higher scores indicating the greater impact of migraine on life.
Migraine-specific Quality of life	Baseline，4 weeks after treatment，8 weeks after treatment，4 weeks after follow-up visiting，12 weeks after follow-up visiting，and 24 weeks after follow-up visiting	Quality of life will be measure by migraine-specific quality of life (MSQOL) scale.This questionnaire consists of 25 items, with 4 answers for each question. The overall format and scores are as follows: 1.Very much; 2. Many; 3. Some; 4. Not at all. The overall scale ranges from 25 to 100, with higher scores indicating the better quality of life.

Trial Locations

Locations (1)

The Third Affiliated Hospital of Zhejiang Chinese Medical University; 🇨🇳 Hangzhou, Zhejiang, China