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Completed

NCT Number: NCT03015753

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Hong Kong Polytechnic University

Hung Hom, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tai Chi training

Behavioral

The 12-week Tai Chi training will be prescribed with three 1-hour instructor-led sessions and two 1-hour self-practice sessions per week. A modified 32-short form Yang-style Tai Chi Chuan will be adopted. The instructor-led sessions will be operated by qualified Tai Chi masters. The training activity will be delivered in group. The group size is 15 to 18 persons.

Waiting list control group

Other

At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.

Primary outcomes

  1. The difference in frequency of migraine attacks (the number of attacks per month)

    Time frame: From baseline to 12 weeks

  2. The proportion of responders

    Time frame: From baseline to 12 weeks

    Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month

Secondary outcomes

  1. Duration of headache attack

    Time frame: From the baseline to 12 weeks and 24 weeks

  2. Intensity of headache

    Time frame: From the baseline to 12 weeks and 24 weeks

    Intensity of headache will be measured by a Visual Analogue Scale.

  3. Stress status

    Time frame: From the baseline to 12 weeks and 24 weeks

    The Perceived Stress Scale (PSS) will be used to measure the stress level.

  4. Sleep quality

    Time frame: From the baseline to 12 weeks and 24 weeks

    The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.

  5. Sleep quantity

    Time frame: From the baseline to 12 weeks and 24 weeks

    A 7-day daily sleep log will be used to measure the sleep quantity.

  6. Fatigue level

    Time frame: From the baseline to 12 weeks and 24 weeks

    The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.

  7. HRQoL

    Time frame: From the baseline to 12 weeks and 24 weeks

    HRQoL will be measured by using the Chinese version of the SF-36.

  8. Weight

    Time frame: From the baseline to 12 weeks and 24 weeks

    Weight in kilograms

  9. Height

    Time frame: From the baseline to 12 weeks and 24 weeks

    Height in meters

  10. Waist circumference

    Time frame: From the baseline to 12 weeks and 24 weeks

    Waist in cm

  11. Hip circumference

    Time frame: From baseline to 12 weeks and 24 weeks

    Hip circumference in cm

  12. Percent body fat

    Time frame: From the baseline to 12 weeks and 24 weeks

  13. Session attendance rate

    Time frame: From baseline to 12 weeks

    Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session

  14. 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

    Time frame: 12 weeks after Tai Chi training

    This is to measure the maintenance of Tai Chi practice

  15. 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

    Time frame: 12 weeks after Tai Chi training

    This is to measure the maintenance of Tai Chi practice

  16. Participation rate

    Time frame: At baseline assessment (4 weeks)

    This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study

  17. Dropout rate

    Time frame: From the baseline to 12 weeks and 24 weeks

    Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline

  18. Adverse events

    Time frame: During intervention period (12 weeks)

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Registry information

Official study title

A Pilot Randomized Controlled Trial to Test the Complementary Therapeutic Efficacy of Tai Chi for the Prophylaxis of Episodic Migraine in Chinese Women

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 10, 2017
Registry last updated
May 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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