TY - JOUR
T1 - Tai Chi for the prophylaxis of episodic migraine: protocol of a non-inferiority randomized controlled trial with mechanism exploration
AU - Xie, Yao Jie
AU - Liao, Xiaoli
AU - Hui, Stanley Sai chuen
AU - Tian, Longben
AU - Yeung, Wing Fai
AU - Lau, Alexander Yuk lun
AU - Tyrovolas, Stefanos
AU - Gao, Yang
AU - Chen, Xiangyan
N1 - Funding Information:
This study is supported by the General Research Fund of the Research Grants Council of Hong Kong (Reference no.: 15100822). This funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Funding Information:
The protocol has been peer reviewed by the Research Grants Council, General Research Fund (Reference Number: 15100822) and has been approved by the Institutional Review Board, Hong Kong Polytechnic University (PolyU IRB) (Reference Number: HSEARS20220721006). Written informed consent will be obtained from each participant after a verbal and a written explanation (via an information sheet) of the purpose and procedures of the study. All methods were performed in accordance with the Declaration of Helsinki.
Publisher Copyright:
© 2023, BioMed Central Ltd., part of Springer Nature.
PY - 2023/9/18
Y1 - 2023/9/18
N2 - 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.
AB - 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.
KW - Migraine
KW - Randomized controlled trial
KW - Tai Chi
KW - Women
KW - prophylaxis
UR - http://www.scopus.com/inward/record.url?scp=85171571690&partnerID=8YFLogxK
U2 - 10.1186/s12906-023-04154-x
DO - 10.1186/s12906-023-04154-x
M3 - Journal article
C2 - 37723467
AN - SCOPUS:85171571690
SN - 1472-6882
VL - 23
JO - BMC Complementary Medicine and Therapies
JF - BMC Complementary Medicine and Therapies
IS - 1
M1 - 328
ER -
