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

NCT06967909 | Not Yet Recruiting

• 1 other identifier: 23B2-029A
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraine; Migraine Disorder

Keywords

Migraine; Tai Chi; Acupuncture; Women; Prophylaxis

Outcome Measures

Primary Outcomes (3)

• The difference in frequency of migraine attacks

  The frequency of migraine attacks will be measured by the number of attacks per month.

  Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization

• The difference in migraine days

  The frequency of migraine days will be measured by the days with migraine attacks per month.

  Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization

• The difference of white matter abnormalities (WMAs)

  All the participants in the Tai Chi group will be measured with MRI. The appearance, number, size and location of WMAs will be recorded. Two experienced neurologists or neuroradiologists will be invited to review the MRI scans independently. Scheltens' visual rating scale will be used to measure the degree of WMAs. Briefly, WMAs will be separately graded in each of the following locations: frontal lobes, temporal lobes, parietal lobes and occipital lobes. WMAs will be graded as follows: 0 (no lesions), 1 (hyperintensity \< 3 mm and n ≤ 5), 2 (\< 3 mm and n ≥ 6), 3 (4-10 mm and n ≤ 5), 4 (4-10 mm and n ≥ 6), 5 (≥ 11 mm and n ≥ 1), and 6 (confluent). The sum of scores from each location will be considered as the final score. Only the women who are identified WMAs (Scheltens' visual rating scores \>0) will take the MRI test again at the 24th week.

  From the baseline to 24 weeks

Secondary Outcomes (16)

• The proportion of responders

  From the baseline to 12 weeks and 24 weeks

• The intensity of the headache

  From the baseline to 12 weeks and 24 weeks

• The duration of headache

  From the baseline to 12 weeks and 24 weeks

• Migraine related disability

  From the baseline to 12 weeks and 24 weeks

• Stress level

  From the baseline to 12 weeks and 24 weeks

Study Arms (2)

Tai Chi training

EXPERIMENTAL

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

Behavioral: Tai Chi training

Acupuncture

ACTIVE COMPARATOR

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

Procedure: Acupuncture

Interventions

Tai Chi training 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.

Tai Chi training

Acupuncture 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.

Acupuncture

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Yao Jie Xie, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Jie Xie, PhD

CONTACT

(852) 3400 3798; grace.yj.xie@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)