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

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.

Conditions

• Migraine
• Migraine Disorder

Interventions

BEHAVIORAL

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.

PROCEDURE

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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University

  lead OTHER

Principal Investigators

• Yao Jie Xie, PhD · The Hong Kong Polytechnic University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-06-01

Primary Completion

2026-06-01

Completion

2026-09-01

Countries

• Hong Kong

Study Locations