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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Migraine Disorders

Treatments: Drug: Standard prophylactic medication; Behavioral: Tai Chi training

Study type: Interventional

Funder types: Other

Identifiers

NCT05690737

A0041948

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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220 participants in 2 patient groups

Tai Chi training

Experimental group

Description:

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.

Treatment:

Behavioral: Tai Chi training

Standard prophylactic medication

Active Comparator group

Description:

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

Treatment:

Drug: Standard prophylactic medication