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

Overview

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.

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
• 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 treatme

Primary outcome measures

• The difference in frequency of migraine attacks [Time frame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization]
• The difference in frequency of migraine days [Time frame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization]
• The difference of white matter abnormalities (WMAs) [Time frame: From the baseline to 24 weeks and 48 weeks]
• The difference of pulsatility index (PI) [Time frame: From the baseline to 24 weeks and 48 weeks]
• The difference of mean blood flow velocity (MBFV) [Time frame: From the baseline to 24 weeks and 48 weeks]
• The difference of impaired cerebrovascular responsiveness (CVR). [Time frame: From the baseline to 24 weeks and 48 weeks]

Secondary outcome measures (12)

• The proportion of responders [Time frame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization]
• The intensity of the headache [Time frame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization]
• The duration of headache [Time frame: Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization]
• Migraine related disability [Time frame: From the baseline to 24 weeks and 48 weeks]
• Stress level [Time frame: From the baseline to 24 weeks and 48 weeks]
• Sleep quality [Time frame: From the baseline to 24 weeks and 48 weeks]
• Fatigue level [Time frame: From the baseline to 24 weeks and 48 weeks]
• Health related Quality-of-Life [Time frame: From the baseline to 24 weeks and 48 weeks]
• Weight [Time frame: From the baseline to 24 weeks and 48 weeks]
• Height [Time frame: From the baseline to 24 weeks and 48 weeks]
• Waist circumference [Time frame: From the baseline to 24 weeks and 48 weeks]
• Hip circumference [Time frame: From the baseline to 24 weeks and 48 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Hong Kong · 2 centers

• The Hong Kong Polytechnic University — Hong Kong
• The Hong Kong Polytechnic University — Hung Hom

Publications

• 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

Identifiers

NCT: NCT05690737 · A0041948

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗