MigraineNCT06967909
Tai Chi and Acupuncture on Migraine Attack Prevention and Brain White Matter Changes
A study testing Tai Chi training and Acupuncture in people with Migraine and Migraine Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Migraine, Migraine Disorder
- What is being tested?
- Tai Chi training and Acupuncture
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Hong Kong Polytechnic University
Hung Hom, Hong Kong
Yao Jie Xie, PhD, (852) 3400 3798, grace.yj.xie@polyu.edu.hk
Yao Jie Xie, PhD
About this study
Official title: 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
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:
Read more
- 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.
Read the detailed description
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.
- Conditions
- Migraine, Migraine Disorder
- Being tested
- Tai Chi training, Acupuncture
- Keywords
- Migraine, Tai Chi, Acupuncture, Women, Prophylaxis
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi trainingBehavioural
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 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.
AcupunctureProcedure or surgery
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 years of clinical experience.
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi training | Experimental | Participants in this arm will receive 24-week Tai Chi training. Receives: Behavioral: Tai Chi training |
| Acupuncture | Active comparator | Participants in this arm will receive 30 sessions of acupuncture treatment over a period of 24 weeks. Receives: Procedure: Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in frequency of migraine attacks
The frequency of migraine attacks will be measured by the number of attacks per month.
Measured: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization
The difference in migraine days
The frequency of migraine days will be measured by the days with migraine attacks per month.
Measured: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization
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.
Measured: From the baseline to 24 weeks
Secondary outcomes (16)
The proportion of responders
Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month.
Measured: From the baseline to 12 weeks and 24 weeks
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.
Measured: From the baseline to 12 weeks and 24 weeks
The duration of headache
The duration of headache recorded in the migraine diary to the nearest 0.1 hour.
Measured: From the baseline to 12 weeks and 24 weeks
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.
Measured: From the baseline to 12 weeks and 24 weeks
Stress level
Stress level evaluated by the Perceived Stress Scale-14 (PSS-14). The total score of PSS-14 ranges from 0 to 56 with higher scores indicating higher perceived stress.
Measured: From the baseline to 12 weeks and 24 weeks
Sleep quality
Sleep quality examined by the Chinese version of the Pittsburgh Sleep Quality Index (PSQI). The global score of PSQI ranges from 0 to 21 with a higher score indicating worse sleep quality.
Measured: From the baseline to 12 weeks and 24 weeks
Fatigue level
Fatigue level evaluated by the Numeric Rating Scale-fatigue scale (NRS). NRS evaluates fatigue level at a 0-to-10 scale, with 0 indicating no fatigue and 10 indicating the worst possible fatigue.
Measured: From the baseline to 12 weeks and 24 weeks
Health related Quality-of-Life
Health related Quality-of-Life measured by the Migraine-Specific Quality-of-Life Questionnaire (MSQ). The total scores of MSQ range from 0-100, with a higher score indicating better Quality-of-Life.
Measured: From the baseline to 12 weeks and 24 weeks
Weight
Weight in kilograms
Measured: From the baseline to 12 weeks and 24 weeks
Height
Height in meters
Measured: From the baseline to 12 weeks and 24 weeks
Waist circumference
Waist circumference in centimeter
Measured: From the baseline to 12 weeks and 24 weeks
Hip circumference
Hip circumference in centimeter
Measured: From the baseline to 12 weeks and 24 weeks
Percent body fat
Percent body fat in %
Measured: From the baseline to 12 weeks and 24 weeks
The difference of pulsatility index (PI)
PI in neck vessels will be measured and recorded by Transcranial Doppler (TCD).
Measured: From the baseline to 12 weeks and 24 weeks
The difference of mean blood flow velocity (MBFV)
MBFV in neck vessels will be measured and recorded by Transcranial Doppler (TCD).
Measured: From the baseline to 12 weeks and 24 weeks
The difference of impaired cerebrovascular responsiveness (CVR)
CVR in neck vessels will be measured and recorded by Transcranial Doppler (TCD).
Measured: From the baseline to 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Jan 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, XIE Yao Jie Grace, The Hong Kong Polytechnic University
- Investigators
- Yao Jie Xie, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967909
- Sponsor's protocol ID
- 23B2-029A
- Status last verified
- Jul 2026
- First submitted
- 5 May 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06967909
- Acronym / sponsor ID
- 23B2-029A
- Conditions
- Migraine, Migraine Disorder
- Keywords
- Migraine, Tai Chi, Acupuncture, Women, Prophylaxis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi training | Experimental | Behavioral: Tai Chi trainingParticipants in this arm will receive 24-week Tai Chi training. |
| Acupuncture | Active comparator | Procedure: AcupunctureParticipants in this arm will receive 30 sessions of acupuncture treatment over a period of 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi trainingParticipants 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. | Behavioural | Tai Chi training |
| AcupunctureParticipants 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. | Procedure or surgery | Acupuncture |
Primary outcome
The difference in frequency of migraine attacks
Time frame: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization
The frequency of migraine attacks will be measured by the number of attacks per month.
The difference in migraine days
Time frame: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization
The frequency of migraine days will be measured by the days with migraine attacks per month.
The difference of white matter abnormalities (WMAs)
Time frame: From the baseline to 24 weeks
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.
16 secondary outcomes
The proportion of responders
Time frame: From the baseline to 12 weeks and 24 weeks
The intensity of the headache
Time frame: From the baseline to 12 weeks and 24 weeks
The duration of headache
Time frame: From the baseline to 12 weeks and 24 weeks
Migraine related disability
Time frame: From the baseline to 12 weeks and 24 weeks
Stress level
Time frame: From the baseline to 12 weeks and 24 weeks
Sleep quality
Time frame: From the baseline to 12 weeks and 24 weeks
Fatigue level
Time frame: From the baseline to 12 weeks and 24 weeks
Health related Quality-of-Life
Time frame: From the baseline to 12 weeks and 24 weeks
Weight
Time frame: From the baseline to 12 weeks and 24 weeks
Height
Time frame: From the baseline to 12 weeks and 24 weeks
Waist circumference
Time frame: From the baseline to 12 weeks and 24 weeks
Hip circumference
Time frame: From the baseline to 12 weeks and 24 weeks
Percent body fat
Time frame: From the baseline to 12 weeks and 24 weeks
The difference of pulsatility index (PI)
Time frame: From the baseline to 12 weeks and 24 weeks
The difference of mean blood flow velocity (MBFV)
Time frame: From the baseline to 12 weeks and 24 weeks
The difference of impaired cerebrovascular responsiveness (CVR)
Time frame: From the baseline to 12 weeks and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yao Jie Xie, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi training and Acupuncture in people with Migraine and Migraine Disorder, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yao Jie Xie, PhD ((852) 3400 3798, grace.yj.xie@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in frequency of migraine attacks (time frame: Between 4 weeks before randomization and weeks 9-12 / 21-24 after randomization). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.