Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial
Abstract Background Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesi...
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BMC
2021-07-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-021-05429-9 |
| _version_ | 1818872325071699968 |
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| author | Na Nie Le Chen Tong Li Chuanlong Zhou Bangwei Li Conghua Ji Jie Zhou Qin Chen Qiushuang Li Yi Liang Jianqiao Fang |
| author_facet | Na Nie Le Chen Tong Li Chuanlong Zhou Bangwei Li Conghua Ji Jie Zhou Qin Chen Qiushuang Li Yi Liang Jianqiao Fang |
| author_sort | Na Nie |
| collection | DOAJ |
| description | Abstract Background Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesic effect remains unknown and needs further study. Methods/Design This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2 Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks − 4–0), a 4-week-long treatment period (weeks 1–4) and a 12-week-long follow-up period (weeks 5–16). Twelve treatment sessions will be performed over a 4-week period (weeks 1–4). The primary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of week 4 post-randomisation. The secondary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of weeks 8, 12 and16 post-randomisation; number of days with migraine; dosage of ibuprofen; the scores of visual analogue scale (VAS); Self-Rating Anxiety Scale (SAS); Self-Rating Depression Scale (SDS); and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 weeks at the end of weeks 4, 8, 12 and 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. Discussion The recruitment will be started on 1 June 2021 and expected to finish on 31 May 2023. We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur. Trial registration Chinese Clinical Trial Registry ChiCTR-1800017259 . Registered on 20 July 2018. |
| first_indexed | 2024-12-19T12:37:01Z |
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| id | doaj.art-4e2cbb2a615e49bdae55a53a76a57ca4 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-19T12:37:01Z |
| publishDate | 2021-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-4e2cbb2a615e49bdae55a53a76a57ca42022-12-21T20:21:06ZengBMCTrials1745-62152021-07-012211910.1186/s13063-021-05429-9Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trialNa Nie0Le Chen1Tong Li2Chuanlong Zhou3Bangwei Li4Conghua Ji5Jie Zhou6Qin Chen7Qiushuang Li8Yi Liang9Jianqiao Fang10Department of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Third School of Clinical Medical, Zhejiang Chinese Medical UniversityThe Third School of Clinical Medical, Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Clinical Research Institute of Zhejiang Provincial Hospital of TCMDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityThe Clinical Research Institute of Zhejiang Provincial Hospital of TCMDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityDepartment of Acupuncture, The Third Affiliated Hospital of Zhejiang Chinese Medical UniversityAbstract Background Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Electroacupuncture (EA) has been used worldwidely to treat several pain-related diseases including migraines. However, whether EA with low or high frequency exerts a distinct analgesic effect remains unknown and needs further study. Methods/Design This study is a randomised, single-blinded, placebo-controlled trial with three parallel arms. A total of 144 migraine outpatients will be randomly allocated to the 2 Hz EA group, 100 Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week-long baseline assessment period (weeks − 4–0), a 4-week-long treatment period (weeks 1–4) and a 12-week-long follow-up period (weeks 5–16). Twelve treatment sessions will be performed over a 4-week period (weeks 1–4). The primary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of week 4 post-randomisation. The secondary outcome will be measured by the frequency of migraine attacks in the past 4 weeks at the end of weeks 8, 12 and16 post-randomisation; number of days with migraine; dosage of ibuprofen; the scores of visual analogue scale (VAS); Self-Rating Anxiety Scale (SAS); Self-Rating Depression Scale (SDS); and Migraine Specific Quality of Life questionnaire (MSQ) in the past 4 weeks at the end of weeks 4, 8, 12 and 16 post-randomisation. Safety assessment, compliance and blinding evaluation will be carried out at the end of week 16 post-randomisation. Discussion The recruitment will be started on 1 June 2021 and expected to finish on 31 May 2023. We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur. Trial registration Chinese Clinical Trial Registry ChiCTR-1800017259 . Registered on 20 July 2018.https://doi.org/10.1186/s13063-021-05429-9Study protocolEAMigraineRandomised placebo-controlled trial |
| spellingShingle | Na Nie Le Chen Tong Li Chuanlong Zhou Bangwei Li Conghua Ji Jie Zhou Qin Chen Qiushuang Li Yi Liang Jianqiao Fang Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial Trials Study protocol EA Migraine Randomised placebo-controlled trial |
| title | Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial |
| title_full | Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial |
| title_fullStr | Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial |
| title_full_unstemmed | Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial |
| title_short | Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial |
| title_sort | comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients study protocol for a randomised placebo controlled trial |
| topic | Study protocol EA Migraine Randomised placebo-controlled trial |
| url | https://doi.org/10.1186/s13063-021-05429-9 |
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