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RECRUITING
NCT05690737
NA

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

Sponsor: The Hong Kong Polytechnic University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2023-09-11

Completion Date

2025-12-31

Last Updated

2025-04-03

Healthy Volunteers

No

Interventions

BEHAVIORAL

Tai 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.

DRUG

Standard 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.

Locations (2)

The Hong Kong Polytechnic University

Hong Kong, HONG KONG, Hong Kong

The Hong Kong Polytechnic University

Hung Hom, Hong Kong