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 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.

• Authors: Na Nie, Le Chen, Tong Li, Chuanlong Zhou, Bangwei Li, Conghua Ji, Jie Zhou, Qin Chen, Qiushuang Li, Yi Liang, Jianqiao Fang
• Journal: Trials (Trials) Vol. 22 Issue 1 Pg. 483 (Jul 23 2021) ISSN: 1745-6215 [Electronic] England
• PMID: 34301299 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: © 2021. The Author(s).

Topics

• Electroacupuncture
• Headache
• Humans
• Migraine Disorders (diagnosis, therapy)
• Outpatients
• Quality of Life
• Randomized Controlled Trials as Topic
• Treatment Outcome