RecruitingNot ApplicableNCT05690737

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

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

Sponsor

The Hong Kong Polytechnic University

Enrollment

220 participants

Start Date

Sep 11, 2023

Study Type

INTERVENTIONAL

Conditions

Migraine Disorders

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria8

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 Criteria9

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.

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Interventions

BEHAVIORALTai Chi training

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.

DRUGStandard prophylactic medication

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.