Effectiveness of Tai Chi and Acupuncture on Migraine Attack Prevention and Brain White Matter Changes: A Non-Inferiority RCT

Официальное название

Effectiveness of Tai Chi and Acupuncture in the Prophylaxes of Episodic Migraine in Hong Kong Chinese Women and the Analysis of Microstructural White Matter Alterations: a Non-inferiority Single-blind Randomized Controlled Trial

Обзор

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.

Подробное описание

The goal of this clinical trial is to determine whether Tai Chi training has the similar effectiveness in reducing the frequency of migraine attacks as acupuncture; and whether both Tai Chi and acupuncture can improve structural brain changes in women with episodic migraine. It also aims to examine whether the improvements in migraine features are linked to the structural brain changes and better cerebrovascular function after the intervention.

This study is a randomized controlled trial with 132 women who have episodic migraines. Participants will be randomly assigned to either the Tai Chi training group or the acupuncture treatment group, with 66 individuals in each group.

Participants will:

* receive a 24-week intervention, which the Tai Chi group attends instructor-led training sessions and self-practice sessions, and the acupuncture group receives 30 treatment sessions over the same period. * Undergo assessments, including migraine diaries for migraine features and symptoms; migraine characteristics, lifestyle factors, body measurements (e.g., height, weight, and body composition), and advanced imaging techniques including MRI and TCD scans. * Data will be collected at baseline, the 12th week, and the 24th week. MRI will be used to assess white matter changes, while TCD will be used to evaluate cerebrovascular function. Both procedures are safe and non-invasive, with specific pre-exam precautions.

To ensure participant safety, Tai Chi sessions will be closely monitored for any adverse effects such as dizziness or falls, while acupuncture treatments will be supervised to address any discomfort. If participants experience intolerable migraines, they will receive guided medication management.

Confidentiality will be strictly maintained, with encrypted data storage and restricted access for research auditing. Personal identifiers will not be linked to the data, and all records will be securely stored for five years before being destroyed.

Вмешательства

• Поведенческое Tai Chi training
  Participants 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
• Процедура Acupuncture
  Participants 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 y

Первичные конечные точки

• The difference in frequency of migraine attacks [Срок оценки: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization]
• The difference in migraine days [Срок оценки: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization]
• The difference of white matter abnormalities (WMAs) [Срок оценки: From the baseline to 24 weeks]

Вторичные конечные точки (12)

• The proportion of responders [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• The intensity of the headache [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• The duration of headache [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Migraine related disability [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Stress level [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Sleep quality [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Fatigue level [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Health related Quality-of-Life [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Weight [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Height [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Waist circumference [Срок оценки: From the baseline to 12 weeks and 24 weeks]
• Hip circumference [Срок оценки: From the baseline to 12 weeks and 24 weeks]

Критерии участия

Критерии включения

• 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;
• Residing in Hong Kong.

Критерии исключения

• 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.);
• Received alternative treatments for migraines (such as acupuncture or Chinese medicine) during the recruitment period or within the past 12 weeks;
• Undergoing preventive medication treatment for migraines during the recruitment period or within the past 12 weeks;
• Excessive use of medication, taking antipsychotic or antidepressant drugs, or using analgesics for other chronic pain conditions for more than 3 days per month within the past 12 weeks;
• Diagnosed with epilepsy or having a mental illness;
• Pregnant, breastfeeding, or currently taking contraceptive medication.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Гонконг · 1 центр

• The Hong Kong Polytechnic University — Hung Hom

Идентификаторы

NCT: NCT06967909 · 23B2-029A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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