Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial
Introduction Approximately 1.4%–2.2% of the global population suffers from chronic migraine. Acupuncture may serve as an alternative management for chronic migraine, where pharmacological prophylaxis is not suitable. However, the effects of acupuncture as migraine prophylaxis have not been confirmed...
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BMJ Publishing Group
2018-05-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/8/5/e020653.full |
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| author | Claire Shuiqing Zhang Bin Li Lin Zeng Lu Liu Luo-peng Zhao Kelun Wang Jingxia Zhao Linpeng Wang Xianghong Jing |
| author_facet | Claire Shuiqing Zhang Bin Li Lin Zeng Lu Liu Luo-peng Zhao Kelun Wang Jingxia Zhao Linpeng Wang Xianghong Jing |
| author_sort | Claire Shuiqing Zhang |
| collection | DOAJ |
| description | Introduction Approximately 1.4%–2.2% of the global population suffers from chronic migraine. Acupuncture may serve as an alternative management for chronic migraine, where pharmacological prophylaxis is not suitable. However, the effects of acupuncture as migraine prophylaxis have not been confirmed. This study is designed as a single-blinded, double-dummy randomised controlled trial to evaluate the efficacy and safety of acupuncture compared with topiramate in patients with chronic migraine.Methods and analysis A total of 60 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and real medicine (topiramate). All participants will receive a 12-week treatment and then be followed up for another 12 weeks. The primary outcome is the reduction of monthly headache days, and the secondary outcomes include the reduction of the number of days with acute headache medications, and changes of Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire, Headache Impact Test, State-Trait Anxiety Inventory-trait, and Beck Depression Inventory-II scores from baseline to endpoints.Ethics and dissemination Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2017BL-045-01). Written informed consent will be obtained from all participants. Outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration number ISRCTN13563102; Pre-results. |
| format | Article |
| id | doaj-art-94b9ead74f284e4fa2b7213ae5027f05 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2018-05-01 |
| publisher | BMJ Publishing Group |
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| series | BMJ Open |
| spelling | doaj-art-94b9ead74f284e4fa2b7213ae5027f052025-02-02T02:05:14ZengBMJ Publishing GroupBMJ Open2044-60552018-05-018510.1136/bmjopen-2017-020653Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trialClaire Shuiqing Zhang0Bin Li1Lin Zeng2Lu Liu3Luo-peng Zhao4Kelun Wang5Jingxia Zhao6Linpeng Wang7Xianghong Jing84 School of Health and Biomedical Sciences, RMIT University, Melbourne, Victoria, AustraliaBiliary Tract Surgery Department I, Eastern Hepatobiliary Surgery Hospital, Secondary Military Medicine University, Shanghai, China1 Department of Geriatric Endocrinology and Metabolism, Guangxi Academy of Medical Sciences and the People’s Hospital of Guangxi Zhuang Autonomous Region, Nanning, Guangxi, China2 Institute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, China1 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China6 Department of Health Science and Technology, Centre for Sensory-Motor Interaction (SMI), Aalborg University, Aalborg, Denmark1 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, China1 Acupuncture and Moxibustion Department, Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University, Beijing, ChinaInstitute of Acupuncture and Moxibustion, China Academy of Chinese Medical Sciences, Beijing, ChinaIntroduction Approximately 1.4%–2.2% of the global population suffers from chronic migraine. Acupuncture may serve as an alternative management for chronic migraine, where pharmacological prophylaxis is not suitable. However, the effects of acupuncture as migraine prophylaxis have not been confirmed. This study is designed as a single-blinded, double-dummy randomised controlled trial to evaluate the efficacy and safety of acupuncture compared with topiramate in patients with chronic migraine.Methods and analysis A total of 60 participants will be randomly assigned to two different groups. Participants will receive verum acupuncture and placebo medicine in the treatment group, while participants in the control group will be treated with sham acupuncture and real medicine (topiramate). All participants will receive a 12-week treatment and then be followed up for another 12 weeks. The primary outcome is the reduction of monthly headache days, and the secondary outcomes include the reduction of the number of days with acute headache medications, and changes of Migraine Disability Assessment, Migraine-Specific Quality of Life Questionnaire, Headache Impact Test, State-Trait Anxiety Inventory-trait, and Beck Depression Inventory-II scores from baseline to endpoints.Ethics and dissemination Ethical approval of this study was granted by the Research Ethical Committee of Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University (2017BL-045-01). Written informed consent will be obtained from all participants. Outcomes of the trial will be disseminated through peer-reviewed publications.Trial registration number ISRCTN13563102; Pre-results.https://bmjopen.bmj.com/content/8/5/e020653.full |
| spellingShingle | Claire Shuiqing Zhang Bin Li Lin Zeng Lu Liu Luo-peng Zhao Kelun Wang Jingxia Zhao Linpeng Wang Xianghong Jing Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial BMJ Open |
| title | Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial |
| title_full | Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial |
| title_fullStr | Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial |
| title_full_unstemmed | Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial |
| title_short | Acupuncture as prophylaxis for chronic migraine: a protocol for a single-blinded, double-dummy randomised controlled trial |
| title_sort | acupuncture as prophylaxis for chronic migraine a protocol for a single blinded double dummy randomised controlled trial |
| url | https://bmjopen.bmj.com/content/8/5/e020653.full |
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