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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorThe Hong Kong Polytechnic University

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tai Chi training

    Behavioral

    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.

  • Standard prophylactic medication

    Drug

    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.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: Tai Chi trainingExperimental treatment 1 intervention
Group B: Standard prophylactic medicationActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The difference in frequency of migraine attacks

The frequency of migraine attacks will be measured by the number of attacks per month.

Time frame
Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
2

The difference in frequency of migraine days

The frequency of migraine days will be measured by the days with migraine attacks per month.

Time frame
Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
3

The difference of white matter abnormalities (WMAs)

All the participants in the Tai Chi group will be measured with MRI. The appearance, number, size and location of WMAs will be recorded. Two experienced neurologists or neuroradiologists will be invited to review the MRI scans independently. Scheltens' visual rating scale will be used to measure the degree of WMAs. Briefly, WMAs will be separately graded in each of the following locations: frontal lobes, temporal lobes, parietal lobes and occipital lobes. WMAs will be graded as follows: 0 (no lesions), 1 (hyperintensity \< 3 mm and n ≤ 5), 2 (\< 3 mm and n ≥ 6), 3 (4-10 mm and n ≤ 5), 4 (4-10 mm and n ≥ 6), 5 (≥ 11 mm and n ≥ 1), and 6 (confluent). The sum of scores from each location will be considered as the final score. Only the women who are identified WMAs (Scheltens' visual rating scores \>0) will take the MRI test again at the 24th week and 48th week.

Time frame
From the baseline to 24 weeks and 48 weeks
4

The difference of pulsatility index (PI)

PI in all intracranial and neck vessels will be measured and recorded by Transcranial Doppler (TCD).

Time frame
From the baseline to 24 weeks and 48 weeks

Secondary outcomes

1

The proportion of responders

Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month

Time frame
Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
2

The intensity of the headache

The intensity of the headache measured by a Visual Analogue Scale (VAS). This scale is most commonly anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10). Higher scores indicate higher level of headache intensity.

Time frame
Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
3

The duration of headache

The duration of headache recorded in the migraine diary to the nearest 0.1 hour.

Time frame
Between 4 weeks before randomization and weeks 21-24 / 45-48 after randomization
4

Migraine related disability

Migraine related disability measured by the Migraine Disability Assessment Score (MIDAS). The MIDAS consists of five items that reflect the number of days reported as either missing or with reduced productivity at work, home, and social events in last 3 months and two additional items that assess the number of days with headaches in the last 3 months and a scale of the painfulness of the headaches. The MIDAS is scored as the sum of days reported in the first five questions. Higher scores are indicative of more disability.

Time frame
From the baseline to 24 weeks and 48 weeks

Other outcomes

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