Clinical trial NCT05690737: Tai Chi for the Prophylaxis of Episodic Migraine: the Efficacy Examination and Mechanism Exploration
Official title: A Randomized Controlled Trail to Examine the Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine Compared With Standard Prophylactic Medication in Chinese Women and a Pre-post Neuroimaging and Laboratory-based Study to Explore the Mechanism of Tai Chi's Intervention Effect
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine Disorders
Keywords: Migraine
Tai Chi
Women
Mechanism
Prophylaxis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: A two-arm individual level randomized controlled trial is designed. A total of 220 local women diagnosed with episodic migraine between 18-65 years will be randomly assigned to one of two groups: 1) a Tai Chi training group receiving the 33-short form Yang-style Tai Chi training; or 2) a standard prophylactic medication group receiving the regular medication prescribed by the neurologist. The intervention period will be 24 weeks with another 24 weeks follow-up. The frequency of migraine attack, migraine days, intensity and duration of headache will be recorded by a migraine diary at the baseline, 24th weeks, and 48th weeks. Other outcomes including migraine related disability, stress, sleep quality, fatigue, and QOL will be measured at these three time points. The clinical efficacy will be determined by comparing the differences of outcomes from baseline to the end of the trial between two groups. The MRI and TCD will be used to measure the degree of white matter abnormality and cerebrovascular function, respectively; and the inflammatory markers will also be tested at three time points for Tai Chi participants. The mechanism of intervention effect will be explored by analyzing the changes and associations of migraine features with the process of these neurovascular functions and inflammatory markers during and after the Tai Chi training.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The difference in frequency of migraine attacks
timeFrame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
measure: The difference in frequency of migraine days
timeFrame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
measure: The difference of white matter abnormalities (WMAs)
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: The difference of pulsatility index (PI)
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: The difference of mean blood flow velocity (MBFV)
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: The difference of impaired cerebrovascular responsiveness (CVR).
timeFrame: From the baseline to 24 weeks and 48 weeks
Secondary outcomes:
measure: The proportion of responders
timeFrame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
measure: The intensity of the headache
timeFrame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
measure: The duration of headache
timeFrame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
measure: Migraine related disability
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Stress level
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Sleep quality
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Fatigue level
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Health related Quality-of-Life
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Weight
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Height
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Waist circumference
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Hip circumference
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: Percent body fat
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: TNF- α
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: CGRP
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: CRP
timeFrame: From the baseline to 24 weeks and 48 weeks
measure: IL-6
timeFrame: From the baseline to 24 weeks and 48 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yao Jie Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References: