Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo- controlled trial

Abstract

\n Background: Headache attacks severely impaired life quality and increase economic burden of migraineurs. Electroacupuncture (EA) has been used world-widely to treat several pain-related diseases including migraine. However, whether EA with low- or high-frequency exerts distinct analgesic effect remains unknown and need to 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 2Hz EA group, 100Hz EA group and placebo control group. The duration of the trial is 20 weeks, including a 4-week long baseline assessment period (week-4-0), 4-week long treatment period (week 1-4), and 12-week long follow-up period (week 5-16). Twelve treatment sessions will be performed over a four-week period (week 1-4). The primary outcome will be measured by frequency of migraine attacks in the past 4 week at the end of week 4 post-randomisation. Secondary outcome will be measured by frequency of migraine attacks in the past 4 week at the end of week 8,12,16 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 week at the end of week 4, 8, 12, 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 at 1 June, 2021 and expected to finish at 31 May, 2023. We aimed to clarify the dominant frequency of EA on headache attacks in migraineur. Trial registration: Chinese Clinical Trial Registry, ChiCTR-1800017259. Registered on 20 July 2018.