Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration

Abstract Background Migraine is a complex neurovascular disorder with considerable clinical, social and economic issues. Tai chi has the potential to be an alternative prophylactic treatment for migraine with high safety since the adverse effects and limited efficacy of available medications. Aims T...

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Main Authors: Yao Jie Xie, Xiaoli Liao, Stanley Sai-chuen Hui, Longben Tian, Wing Fai Yeung, Alexander Yuk-lun Lau, Stefanos Tyrovolas, Yang Gao, Xiangyan Chen
Format: Article
Language:English
Published: BMC 2023-09-01
Series:BMC Complementary Medicine and Therapies
Subjects:
Online Access:https://doi.org/10.1186/s12906-023-04154-x
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author Yao Jie Xie
Xiaoli Liao
Stanley Sai-chuen Hui
Longben Tian
Wing Fai Yeung
Alexander Yuk-lun Lau
Stefanos Tyrovolas
Yang Gao
Xiangyan Chen
author_facet Yao Jie Xie
Xiaoli Liao
Stanley Sai-chuen Hui
Longben Tian
Wing Fai Yeung
Alexander Yuk-lun Lau
Stefanos Tyrovolas
Yang Gao
Xiangyan Chen
author_sort Yao Jie Xie
collection DOAJ
description Abstract Background Migraine is a complex neurovascular disorder with considerable clinical, social and economic issues. Tai chi has the potential to be an alternative prophylactic treatment for migraine with high safety since the adverse effects and limited efficacy of available medications. Aims The proposed study aims to compare the prophylaxis efficacy of 24-week Tai Chi training on migraine attacks with the standard prophylactic medication; and to explore the mechanism of Tai Chi in preventing migraine attacks by analyzing the associations between changes of migraine attacks and changes of neurovascular functions and inflammatory makers. Method This is a two-arm parallel non-inferiority randomized controlled trial. In total 220 Hong Kong Chinese women aged 18–65 years with diagnosis of episodic migraine will be recruited and randomized to either the Tai Chi training group or the standard prophylactic medication group with 1:1 ratio, and receive the 24 weeks of modified 33-short form Yang-style Tai Chi training and the standard prophylactic medications, respectively. A 24-week follow-up will be implemented for both groups. For efficacy examination, the primary outcome was the frequency of migraine attacks measured by the migraine diary; and for the mechanism exploration, the primary outcome was the volume and number of white matter hyperintensity (WMH) measured by magnetic resonance imaging (MRI). The measurements will be conducted at the baseline, 24th weeks, and 48th weeks. Linear mixed model will be adopted to comprehensively analyze the changes of variables within and between groups. Discussion Given the importance of reducing disease burden and financial cost of migraine attacks, the findings of this study will provide new insights regarding the role of Tai Chi in alleviating migraine burden and further shed light on the mechanism action of Tai Chi on preventing headache attacks. Trial registration ClinicalTrials.gov NCT05690737. Registered on January 28, 2023.
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spelling doaj.art-e4e155a1b92d4b7fae2ccaa0aa2a2e242023-11-19T12:20:42ZengBMCBMC Complementary Medicine and Therapies2662-76712023-09-012311810.1186/s12906-023-04154-xTai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism explorationYao Jie Xie0Xiaoli Liao1Stanley Sai-chuen Hui2Longben Tian3Wing Fai Yeung4Alexander Yuk-lun Lau5Stefanos Tyrovolas6Yang Gao7Xiangyan Chen8School of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic UniversitySchool of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic UniversityDepartment of Sports Science and Physical Education, The Chinese University of Hong KongSchool of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic UniversitySchool of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic UniversityDepartment of Medicine and Therapeutics, Faculty of Medicine, The Chinese University of Hong KongSchool of Nursing, Faculty of Health and Social Sciences, The Hong Kong Polytechnic UniversityDepartment of Sport, Physical Education and Health, Hong Kong Baptist UniversityDepartment of Health Technology and Informatics, Faculty of Health and Social Sciences, The Hong Kong Polytechnic UniversityAbstract Background Migraine is a complex neurovascular disorder with considerable clinical, social and economic issues. Tai chi has the potential to be an alternative prophylactic treatment for migraine with high safety since the adverse effects and limited efficacy of available medications. Aims The proposed study aims to compare the prophylaxis efficacy of 24-week Tai Chi training on migraine attacks with the standard prophylactic medication; and to explore the mechanism of Tai Chi in preventing migraine attacks by analyzing the associations between changes of migraine attacks and changes of neurovascular functions and inflammatory makers. Method This is a two-arm parallel non-inferiority randomized controlled trial. In total 220 Hong Kong Chinese women aged 18–65 years with diagnosis of episodic migraine will be recruited and randomized to either the Tai Chi training group or the standard prophylactic medication group with 1:1 ratio, and receive the 24 weeks of modified 33-short form Yang-style Tai Chi training and the standard prophylactic medications, respectively. A 24-week follow-up will be implemented for both groups. For efficacy examination, the primary outcome was the frequency of migraine attacks measured by the migraine diary; and for the mechanism exploration, the primary outcome was the volume and number of white matter hyperintensity (WMH) measured by magnetic resonance imaging (MRI). The measurements will be conducted at the baseline, 24th weeks, and 48th weeks. Linear mixed model will be adopted to comprehensively analyze the changes of variables within and between groups. Discussion Given the importance of reducing disease burden and financial cost of migraine attacks, the findings of this study will provide new insights regarding the role of Tai Chi in alleviating migraine burden and further shed light on the mechanism action of Tai Chi on preventing headache attacks. Trial registration ClinicalTrials.gov NCT05690737. Registered on January 28, 2023.https://doi.org/10.1186/s12906-023-04154-xMigraineTai ChiWomenRandomized controlled trial
spellingShingle Yao Jie Xie
Xiaoli Liao
Stanley Sai-chuen Hui
Longben Tian
Wing Fai Yeung
Alexander Yuk-lun Lau
Stefanos Tyrovolas
Yang Gao
Xiangyan Chen
Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
BMC Complementary Medicine and Therapies
Migraine
Tai Chi
Women
Randomized controlled trial
title Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
title_full Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
title_fullStr Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
title_full_unstemmed Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
title_short Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
title_sort tai chi for the prophylaxis of episodic migraine protocol of a non inferiority randomized controlled trial with mechanism exploration
topic Migraine
Tai Chi
Women
Randomized controlled trial
url https://doi.org/10.1186/s12906-023-04154-x
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