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

Migraine Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03015753
• Other study ID #: G-UA8P
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: June 2018

Study information

• Verified date: May 2022
• Source: The Hong Kong Polytechnic University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine Disorder
• Migraine Disorders

Intervention

Behavioral:
• Tai Chi training
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.

Other:
• Waiting list control group
At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.

Locations

Country	Name	City	State
Hong Kong	The Hong Kong Polytechnic University	Hung Hom

Sponsors (1)

Lead Sponsor	Collaborator
The Hong Kong Polytechnic University

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in frequency of migraine attacks (the number of attacks per month)		From baseline to 12 weeks
Primary	The proportion of responders	Defined as the proportion of patients with at least a 50% reduction of the number of attacks per month	From baseline to 12 weeks
Secondary	Duration of headache attack		From the baseline to 12 weeks and 24 weeks
Secondary	Intensity of headache	Intensity of headache will be measured by a Visual Analogue Scale.	From the baseline to 12 weeks and 24 weeks
Secondary	Stress status	The Perceived Stress Scale (PSS) will be used to measure the stress level.	From the baseline to 12 weeks and 24 weeks
Secondary	Sleep quality	The Chinese version of the Pittsburgh Sleep Quality Index (PSQI) will be used to measure the sleep quality.	From the baseline to 12 weeks and 24 weeks
Secondary	Sleep quantity	A 7-day daily sleep log will be used to measure the sleep quantity.	From the baseline to 12 weeks and 24 weeks
Secondary	Fatigue level	The Numeric Rating Scale-fatigue (NRS-fatigue) will be used to measure fatigue level.	From the baseline to 12 weeks and 24 weeks
Secondary	HRQoL	HRQoL will be measured by using the Chinese version of the SF-36.	From the baseline to 12 weeks and 24 weeks
Secondary	Weight	Weight in kilograms	From the baseline to 12 weeks and 24 weeks
Secondary	Height	Height in meters	From the baseline to 12 weeks and 24 weeks
Secondary	Waist circumference	Waist in cm	From the baseline to 12 weeks and 24 weeks
Secondary	Hip circumference	Hip circumference in cm	From baseline to 12 weeks and 24 weeks
Secondary	Percent body fat		From the baseline to 12 weeks and 24 weeks
Secondary	Session attendance rate	Number of participants who truly attend the Tai Chi training session divided by the total number of participants in that training session	From baseline to 12 weeks
Secondary	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	This is to measure the maintenance of Tai Chi practice	12 weeks after Tai Chi training
Secondary	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	This is to measure the maintenance of Tai Chi practice	12 weeks after Tai Chi training
Secondary	Participation rate	This outcome is measured by the eligible participants at baseline assessment divided by the subjects who register the study	At baseline assessment (4 weeks)
Secondary	Dropout rate	Number of participants successfully complete the 12-week Tai Chi training and 12-week follow up divided by the number of participants at baseline	From the baseline to 12 weeks and 24 weeks
Secondary	Adverse events		During intervention period (12 weeks)