Clinical trial NCT03015753: The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women
Official title: A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine Disorder
Keywords: Migraine
Tai Chi
Prophylaxis
Randomized controlled trial
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 82
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study aims to preliminarily test the effects of a 12-week Tai Chi training on the prophylaxis of episodic migraine in Chinese women, and to evaluate the feasibility, acceptability, compliance and maintenance of Tai Chi exercise among this population.

Detailed description: Migraine is a disabling neurological condition, characterized by attacks of headache and associated symptoms such as photophobia, nausea, and vomiting. In Hong Kong, the overall prevalence is around 12.5%. People with repeated migraine attacks are pain and personal suffering, have impaired social and personal life, and increased financial cost of medication. More nonpharmacologic prophylactic treatments are needed to reduce the high disease burden. As a body-mind exercise, Tai Chi's potential therapeutic efficacy on the prophylaxis of migraine has caught our attention. The investigators propose to conduct a two-arm individual level randomized controlled trial. Local women diagnosed with episodic migraine between 18-65 years will be randomly assigned to one of two groups: 1) a Tai Chi training ("TC"); or 2) a waiting list control group ("control"). The control group will receive a "delayed" Tai Chi training at the end of the trial. A total of 60 participants will be randomized and the intervention period will be 12 weeks with another 12-week follow-up. Number of attacks per month (frequency of attack), intensity and duration of headache, stress, sleep quality and quantity, fatigue, HRQoL, and body composition will be measured at baseline and at 12 weeks and 24 weeks. The primary outcomes are the difference in frequency of attack from baseline to the 12 weeks after randomization, and the proportion of patients with at least a 50% reduction of the number of attacks per month. The intervention effect will be estimated by calculating the differences of outcomes from baseline to the end of the trial between the intervention and control groups using intention-to-treat analysis.

Eligibility criteria: Inclusion Criteria:

* Female, aged 18-65 years;
* Have a clinical diagnosis of episodic migraine according to ICHD-II criteria at least 2 months prior to enrollment;
* At least one of the following migraine characteristics is met: nausea, vomiting, photophobia, or phonophobia;
* Able to undertake designated level of Tai Chi exercise;
* Live in Hong Kong, can read and speak Cantonese or Putonghua.

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 practice after diagnosis of migraine;
* Regular performance of Tai Chi or other body-mind exercises (yoga, biofeedback, medication, etc.);
* 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.

Primary outcomes:
measure: The difference in frequency of migraine attacks (the number of attacks per month)
timeFrame: From baseline to 12 weeks
measure: The proportion of responders
timeFrame: From baseline to 12 weeks
Secondary outcomes:
measure: Duration of headache attack
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Intensity of headache
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Stress status
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Sleep quality
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Sleep quantity
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Fatigue level
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: HRQoL
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Weight
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Height
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Waist circumference
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Hip circumference
timeFrame: From baseline to 12 weeks and 24 weeks
measure: Percent body fat
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Session attendance rate
timeFrame: From baseline to 12 weeks
measure: The number of weeks the participants in intervention group practice Tai Chi at least one time per week in the 12-week follow up period
timeFrame: 12 weeks after Tai Chi training
measure: The percentage of the participants in the intervention group who keep Tai Chi exercise for 1 time per week and last 6 weeks in the 12-week follow up period
timeFrame: 12 weeks after Tai Chi training
measure: Participation rate
timeFrame: At baseline assessment (4 weeks)
measure: Dropout rate
timeFrame: From the baseline to 12 weeks and 24 weeks
measure: Adverse events
timeFrame: During intervention period (12 weeks)
Other outcomes:
Locations:
city: Hung Hom
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Yao Jie Xie, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wang S, Tian L, Ma T, Wong YT, Yan LJ, Gao Y, Zhang D, Hui SS, Xie YJ. Effectiveness of Tai Chi on Blood Pressure, Stress, Fatigue, and Sleep Quality among Chinese Women with Episodic Migraine: A Randomised Controlled Trial. Evid Based Complement Alternat Med. 2022 Oct 19;2022:2089139. doi: 10.1155/2022/2089139. eCollection 2022.