Effectiveness of Tai Chi and Acupuncture on Migraine Attack Prevention and Brain White Matter Changes: A Non-Inferiority RCT

NCT ID: NCT06967909

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-09-01

Brief Summary

The goal of this clinical trial is to determine the effectiveness of Tai Chi training and acupuncture on the migraine attacks and structural brain changes in women with episodic migraine.

Researchers will compare Tai Chi training to acupuncture treatment in a randomized controlled trial with 132 female participants. Participants will:

• Be randomly assigned to either the Tai Chi group or the acupuncture group.
• Undergo a 24-week intervention, with structured sessions for Tai Chi or scheduled acupuncture treatments.
• Complete assessments through migraine diaries, questionnaires, physical measurements, MRI and TCD scans at various time points.

The study ensures participant safety through close monitoring, with medical support available in case of discomfort. Data confidentiality will be maintained, with encrypted storage and restricted access for research purposes.

Detailed Description

The goal of this clinical trial is to determine whether Tai Chi training has the similar effectiveness in reducing the frequency of migraine attacks as acupuncture; and whether both Tai Chi and acupuncture can improve structural brain changes in women with episodic migraine. It also aims to examine whether the improvements in migraine features are linked to the structural brain changes and better cerebrovascular function after the intervention.

This study is a randomized controlled trial with 132 women who have episodic migraines. Participants will be randomly assigned to either the Tai Chi training group or the acupuncture treatment group, with 66 individuals in each group.

Participants will:

• receive a 24-week intervention, which the Tai Chi group attends instructor-led training sessions and self-practice sessions, and the acupuncture group receives 30 treatment sessions over the same period.
• Undergo assessments, including migraine diaries for migraine features and symptoms; migraine characteristics, lifestyle factors, body measurements (e.g., height, weight, and body composition), and advanced imaging techniques including MRI and TCD scans.
• Data will be collected at baseline, the 12th week, and the 24th week. MRI will be used to assess white matter changes, while TCD will be used to evaluate cerebrovascular function. Both procedures are safe and non-invasive, with specific pre-exam precautions.

To ensure participant safety, Tai Chi sessions will be closely monitored for any adverse effects such as dizziness or falls, while acupuncture treatments will be supervised to address any discomfort. If participants experience intolerable migraines, they will receive guided medication management.

Confidentiality will be strictly maintained, with encrypted data storage and restricted access for research auditing. Personal identifiers will not be linked to the data, and all records will be securely stored for five years before being destroyed.

Conditions

Migraine; Migraine Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Tai Chi training

Participants in this arm will receive 24-week Tai Chi training. F

Group Type: EXPERIMENTAL

Tai Chi training

Intervention Type: BEHAVIORAL

Participants will receive 24 weeks of Tai Chi training. For the first 12 weeks, they will receive 3 instructor-led Tai Chi training sessions per week, and practice 2 Tai Chi sessions by themselves. In the next 12 weeks, they will receive 1 instructor-led Tai Chi session and self-practice 2 Tai Chi sessions per week. A modified 33-short form Yang-style Tai Chi Chuan will be adopted. The Tai Chi sessions will be operated by qualified instructors. Each 1-hour training session consists of 10 minutes brief warm-up stretching session followed by 45 minutes standard Tai Chi routine activities, and 5 minutes of cool-down stretching. The Tai Chi instructors are required to attend a training session that ensure all of them to deliver the same intervention protocol throughout the study. The research assistant will monitor the fidelity of intervention by visiting the Tai Chi sessions frequently. The training session will be delivered in group. The group size is 25-30 persons.

Acupuncture

Participants in this arm will receive 30 sessions of acupuncture treatment over a period of 24 weeks.

Group Type: ACTIVE_COMPARATOR

Acupuncture

Intervention Type: PROCEDURE

Participants in the acupuncture group will receive 30 acupuncture treatment sessions, each last for 1 hour. Acupuncture will be performed every 2 days within one week, followed by a 3-day break, i.e., twice a week for the first 12 weeks; then it will be performed once every two weeks for the next 12 weeks. In total 30 sessions during 24 weeks treatment period. All acupuncture sessions will be administered by registered Traditional Chinese Medicine practitioners in Hong Kong with at least three years of clinical experience.

Interventions

Tai Chi training

Participants will receive 24 weeks of Tai Chi training. For the first 12 weeks, they will receive 3 instructor-led Tai Chi training sessions per week, and practice 2 Tai Chi sessions by themselves. In the next 12 weeks, they will receive 1 instructor-led Tai Chi session and self-practice 2 Tai Chi sessions per week. A modified 33-short form Yang-style Tai Chi Chuan will be adopted. The Tai Chi sessions will be operated by qualified instructors. Each 1-hour training session consists of 10 minutes brief warm-up stretching session followed by 45 minutes standard Tai Chi routine activities, and 5 minutes of cool-down stretching. The Tai Chi instructors are required to attend a training session that ensure all of them to deliver the same intervention protocol throughout the study. The research assistant will monitor the fidelity of intervention by visiting the Tai Chi sessions frequently. The training session will be delivered in group. The group size is 25-30 persons.

Intervention Type: BEHAVIORAL

Acupuncture

Participants in the acupuncture group will receive 30 acupuncture treatment sessions, each last for 1 hour. Acupuncture will be performed every 2 days within one week, followed by a 3-day break, i.e., twice a week for the first 12 weeks; then it will be performed once every two weeks for the next 12 weeks. In total 30 sessions during 24 weeks treatment period. All acupuncture sessions will be administered by registered Traditional Chinese Medicine practitioners in Hong Kong with at least three years of clinical experience.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Chinese women aged 18 years and above;
• Diagnosed with episodic migraines, with or without aura, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3);
• Migraine attack frequency ranging from 2 to 14 days per month (≥15 days/month is classified as chronic migraine and is not included in this study);
• Assessed by a sports specialist as capable of engaging in moderate physical activity;
• Residing in Hong Kong.

Exclusion Criteria

• Unable to engage in moderate physical activity;
• Comorbid with other neurological disorders;
• Experiencing non-migraine headaches for more than 5 days per month;
• Previous practice of Tai Chi or other mind-body exercises (such as yoga, biofeedback, meditation, etc.);
• Received alternative treatments for migraines (such as acupuncture or Chinese medicine) during the recruitment period or within the past 12 weeks;
• Undergoing preventive medication treatment for migraines during the recruitment period or within the past 12 weeks;
• Excessive use of medication, taking antipsychotic or antidepressant drugs, or using analgesics for other chronic pain conditions for more than 3 days per month within the past 12 weeks;
• Diagnosed with epilepsy or having a mental illness;
• Pregnant, breastfeeding, or currently taking contraceptive medication.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

XIE Yao Jie Grace

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yao Jie Xie, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hong Kong Polytechnic University

Locations

The Hong Kong Polytechnic University

Hung Hom, , Hong Kong

Countries

Hong Kong

Central Contacts

Yao Jie Xie, PhD

Role: CONTACT

grace.yj.xie@polyu.edu.hk

(852) 3400 3798

Facility Contacts

Yao Jie Xie, PhD

Role: primary

grace.yj.xie@polyu.edu.hk

(852) 3400 3798

Other Identifiers

23B2-029A

Identifier Type: -

Identifier Source: org_study_id