Autor: |
Na Nie, Le Chen, Tong Li, Chuanlong Zhou, Bangwei Li, Conghua Ji, Jie Zhou, Qin Chen, Qiushuang Li, Yi Liang, Jianqiao Fang |
Jazyk: |
angličtina |
Rok vydání: |
2021 |
Předmět: |
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Zdroj: |
Trials, Vol 22, Iss 1, Pp 1-9 (2021) |
Druh dokumentu: |
article |
ISSN: |
1745-6215 |
DOI: |
10.1186/s13063-021-05429-9 |
Popis: |
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. |
Databáze: |
Directory of Open Access Journals |
Externí odkaz: |
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