The Efficacy of Tai Chi Training for the Prophylaxis of Migraine in Chinese Women

The Hong Kong Polytechnic University

Status: Completed

Conditions: Migraine Disorder

Treatments: Behavioral: Tai Chi training; Other: Waiting list control group

Study type: Interventional

Funder types: Other

Identifiers

NCT03015753

G-UA8P

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

Tai Chi training

Experimental group

Description:

The participants in this arm will receive 12-week Tai Chi training (1 hour per day, 5 days per week).

Treatment:

Behavioral: Tai Chi training

Waiting list control group

Other group

Description:

Participants in this arm will be asked to maintain their usual lifestyles and exercises for 12 weeks. At the end of the trial , the participants will be offered Tai Chi training similar as Tai Chi group.

Treatment:

Other: Waiting list control group