Tai Chi and Acupuncture on Migraine Attack Prevention and Brain White Matter Changes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorThe Hong Kong Polytechnic University
About this trial
The goal of this clinical trial is to determine the effectiveness of Tai Chi training and acupuncture on the migraine attacks and structural brain changes in women with episodic migraine.
Researchers will compare Tai Chi training to acupuncture treatment in a randomized controlled trial with 132 female participants. Participants will:
* Be randomly assigned to either the Tai Chi group or the acupuncture group. * Undergo a 24-week intervention, with structured sessions for Tai Chi or scheduled acupuncture treatments. * Complete assessments through migraine diaries, questionnaires, physical measurements, MRI and TCD scans at various time points.
The study ensures participant safety through close monitoring, with medical support available in case of discomfort. Data confidentiality will be maintained, with encrypted storage and restricted access for research purposes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Chinese women aged 18 years and above;
Diagnosed with episodic migraines, with or without aura, according to the International Classification of Headache Disorders, 3rd edition (ICHD-3);
Migraine attack frequency ranging from 2 to 14 days per month (≥15 days/month is classified as chronic migraine and is not included in this study);
Assessed by a sports specialist as capable of engaging in moderate physical activity;
Disqualifiers
Unable to engage in moderate physical activity;
Comorbid with other neurological disorders;
Experiencing non-migraine headaches for more than 5 days per month;
Previous practice of Tai Chi or other mind-body exercises (such as yoga, biofeedback, meditation, etc.);
Trial design
Design model
Parallel
Treatments tested in this trial
Tai Chi training
BehavioralParticipants will receive 24 weeks of Tai Chi training. For the first 12 weeks, they will receive 3 instructor-led Tai Chi training sessions per week, and practice 2 Tai Chi sessions by themselves. In the next 12 weeks, they will receive 1 instructor-led Tai Chi session and self-practice 2 Tai Chi 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 instructors. Each 1-hour training session consists 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 are required to attend a training session that ensure all of them to 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 session will be delivered in group. The group size is 25-30 persons.
Acupuncture
Procedure/SurgeryParticipants in the acupuncture group will receive 30 acupuncture treatment sessions, each last for 1 hour. Acupuncture will be performed every 2 days within one week, followed by a 3-day break, i.e., twice a week for the first 12 weeks; then it will be performed once every two weeks for the next 12 weeks. In total 30 sessions during 24 weeks treatment period. All acupuncture sessions will be administered by registered Traditional Chinese Medicine practitioners in Hong Kong with at least three years of clinical experience.
Treatment groups
132 Participants
are divided into 2 treatment groupsGroup A: Tai Chi trainingExperimental treatment 1 intervention
Group B: AcupunctureActive 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 9-12 / 21-24 after randomization2
The difference in 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 9-12 / 21-24 after randomization3
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.
Time frame
From the baseline to 24 weeksSecondary 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
From the baseline to 12 weeks and 24 weeks2
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
From the baseline to 12 weeks and 24 weeks3
The duration of headache
The duration of headache recorded in the migraine diary to the nearest 0.1 hour.
Time frame
From the baseline to 12 weeks and 24 weeks4
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 12 weeks and 24 weeksSponsors and contacts
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Source ClinicalTrials.gov