Comparative effect of electroacupuncture with different frequency on headache attacks in migraine outpatients: study protocol for a randomised placebo-controlled trial.
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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.
SUBMITTER: Nie N
PROVIDER: S-EPMC8299449 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectivesTo evaluate if patients with a diagnosis of vestibular migraine (VM) by the International Classification of Headache Disorders (ICHD) criteria have meaningful differences in symptomatology and disease characteristics when compared to patients with concurrent vestibular symptoms and migraine that do not meet ICHD criteria.MethodsPatients who presented for the evaluation of vertigo were provided a detailed questionnaire about dizziness and migraine symptoms. Patients were assigned to either VM cohort (met ICHD criteria for VM) or migraine headache (MH) cohort (met ICHD criteria for migraine with or without aura but not VM). Disease characteristics, symptomatology, quality of life, and perceived stress score were compared between the cohorts.ResultsThe VM cohort demonstrated a shorter duration of vertigo episodes, 11 ± 22 hours versus 84 ± 146 hours in the MH cohort. In the VM cohort, 81% reported experiencing migraine headaches during episodes of vertigo, versus 61% in the MH cohort. All patients in the VM cohort reported a previous diagnosis of migraine headache, whereas 9% of the MH cohort had not been previously diagnosed by another physician. There was no difference in quality of life or perceived stress scores between the cohorts.ConclusionsA large proportion of vertigo patients with migrainous features do not meet the ICHD criteria for VM. The differences between cohorts represent selection bias rather than meaningful features unique to the cohorts. As such, VM and MH with vestibular symptoms may exist on a spectrum of the same disease process and may warrant the same treatment protocols.
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