Abstract
BackgroundHeadache 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/DesignThis 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.DiscussionThe 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 registrationChinese Clinical Trial Registry ChiCTR-1800017259. Registered on 20 July 2018.
Highlights
Headache attacks severely impaired life quality and increase the economic burden of migraineurs
We aimed to clarify the dominant frequency of EA on headache attacks in a migraineur
Previous systematic reviews and clinical trials had indicated that acupuncture and EA exerted a favourable analgesic effect on migraine [19,20,21,22]
Summary
Headache attacks severely impaired life quality and increase the economic burden of migraineurs. Migraineurs suffered from a substantial decline in productive capacity, which led to increasing economic burden and low-quality of life [9]. Migraine became the third cause of disability in people under 50 years of age according to the Global Burden of Disease Study 2015 (GBD 2015) [10]. The mechanisms of migraine attack are not fully understood, and the lack of migraine-targeted drugs still bother migraineurs. Drugs such as beta-adrenoceptor blockers and antidepressants are usually prescribed to alleviate headache attacks. Medication-induced side effects limited clinical effectiveness and reduced patientbased compliance [11, 13]
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