Tai Chi for the Prophylaxis of Episodic Migraine: the Efficacy Examination and Mechanism Exploration

NCT05690737 | Recruiting

• 1 other identifier: A0041948
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study aims to examine the clinical efficacy of 24-week Tai Chi training in the prophylaxis of episodic migraine comparing with standard prophylactic medication in Hong Kong Chinese women, and to explore the mechanism of Tai Chi's intervention effect by examining the associations of changes in migraine features with neurovascular and neuroinflammation variations.

Conditions

Migraine Disorders

Keywords

Migraine; Tai Chi; Women; Mechanism; Prophylaxis

Outcome Measures

Primary Outcomes (6)

• 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 21-24 / 45-48 after randomization

• The difference in frequency of 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 21-24 / 45-48 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 and 48th week.

  From the baseline to 24 weeks and 48 weeks

• The difference of pulsatility index (PI)

  PI in all intracranial and neck vessels will be measured and recorded by Transcranial Doppler (TCD).

  From the baseline to 24 weeks and 48 weeks

• The difference of mean blood flow velocity (MBFV)

  MBFV in all intracranial and neck vessels will be measured and recorded by Transcranial Doppler (TCD).

  From the baseline to 24 weeks and 48 weeks

• The difference of impaired cerebrovascular responsiveness (CVR).

  The CVR will be calculated by: CVR=△MBFV=(Vstim-Vrest)/Vrest\*100, where △MBFV is the relative change of blood flow velocity, Vstim is the blood flow velocity during the stimulation, and Vrest is the baseline flow velocity during the initial 5 min prior to stimulation. The value will be calculated by the mean of both left and right brain and from 10 cycles.

  From the baseline to 24 weeks and 48 weeks

Secondary Outcomes (17)

• The proportion of responders

  Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization

• The intensity of the headache

  Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization

• The duration of headache

  Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization

• Migraine related disability

  From the baseline to 24 weeks and 48 weeks

• Stress level

  From the baseline to 24 weeks and 48 weeks

Study Arms (2)

Tai Chi training

EXPERIMENTAL

The participants in this arm will receive 24-week Tai Chi training (1 hour per day, 5 days per week) with 24-week follow-up. A modified 33-short form Yang-style Tai Chi Chuan will be adopted.

Behavioral: Tai Chi training

Standard prophylactic medication

ACTIVE COMPARATOR

Participants in this arm will receive 48-week standard migraine prophylactic medication following neurologist's recommendation.

Drug: Standard prophylactic medication

Interventions

Tai Chi training BEHAVIORAL

The 24-week Tai Chi training will be prescribed with three 1-hour instructor-led sessions and two 1-hour self-practice 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/certified instructors. Each 1-hour training session will consist 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 will have to attend a training session that ensure all of them will 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 activity will be delivered in group. The group size is 25-30 persons. During the 24 weeks follow-up period, the participants are required to practice Tai Chi with the same frequency by themselves.

Tai Chi training

Standard prophylactic medication DRUG

Participants assigned to the control group will follow the collaborated neurologist's recommendation, to take the prophylactic medication. The Multidisciplinary Panel on Neuropathic Pain (MPNP) of Hong Kong has published the treatment algorithm for migraine, which is in line with the guideline of the Scottish Intercollegiate Guidelines Network (SIGN) on the pharmacological management of migraine (SIGN 155). Beta-blockers, specifically metoprolol and propranolol, are one of the first-line treatments for migraine prophylaxis. The dosage will start on 10mg and slowly increase by 10mg every week until the dosage reached the highest dose of 150mg/day. The whole course will last for 48 weeks. The second line drug such as amitriptyline and the third line drug such as gabapentin will be adopted according to doctor's judgement if necessary. RA will help the participants to make appointment with the neurological doctor, to obtain the prescription. The adverse events will be recorded accordingly.

Standard prophylactic medication

Eligibility Criteria

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

You may qualify if:

• Chinese woman, aged 18-65 years.
• Have a clinical diagnosis of episodic migraine (migraine with less than 15 attacks per month) with or without aura according to the International Classification of Headache Disorders, 3rd edition (ICHD-3).
• First migraine attack before the age of 45 years.
• Between two and six migraine attacks in one month.
• At least one of the following migraine characteristics is met: nausea, vomiting, photophobia, or phonophobia.
• Duration of migraine attacks is 2-72 h without acute medication or at least 1 h with acute medication.
• Able to undertake designated level of Tai Chi exercise.
• Live in Hong Kong.

You may not qualify if:

• Severe migraine attacks with disabilities that cannot perform moderate intensity physical activity.
• Secondary headache and other neurological disease.
• More than 5 days of non-migrainous headache per month.
• Experience with Tai Chi or other body-mind exercises (yoga, biofeedback, medication, etc.) after diagnosis of migraine.
• Undergoing other alternative therapeutic treatments during recruitment period, or received other alternative therapeutic treatments in the past 12 weeks.
• Pregnancy, lactation period, or currently using contraceptives.
• Use of pharmacological prophylactic treatment for migraine in the past 12 weeks.
• Drug abuse, take antipsychotic or antidepressant drugs, or take analgesics for other chronic pain more than 3 days a month in the past 12 weeks.
• Epilepsy, or have a psychiatric disease.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (2)

The Hong Kong Polytechnic University

Hong Kong, HONG KONG, Hong Kong

RECRUITING

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

NOT YET RECRUITING

Related Publications (1)

• Xie YJ, Liao X, Hui SS, Tian L, Yeung WF, Lau AY, Tyrovolas S, Gao Y, Chen X. Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration. BMC Complement Med Ther. 2023 Sep 18;23(1):328. doi: 10.1186/s12906-023-04154-x.

  PMID: 37723467 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Yao Jie Xie, PhD

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yao Jie Xie, PhD

CONTACT

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: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: September 11, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (2)