Migraine Disorders Complicated migraine
Conditions
Interventions
This is a randomized, open-label, controlled clinical trial composed of two groups of women, sham and intervention. An estimated 52 participants are expected, with the study comprising an intervention
Sponsors
Centro de Ciências da Saúde da Universidade Federal do Espírito Santo
Centro de Ciências da Saúde da Universidade Federal do Espírito Santo
Eligibility
Sex/Gender
Female
Age
17 Years to 65 Years
Inclusion criteria
Inclusion criteria: Cisgender women; aged 18 to 65 years; diagnosed with Menstrual Migraine according to the 2018 criteria of The International Classification of Headache Disorders (ICHD-3) for more than 3 months; attacks in menstruating women meeting ICHD-3 criterion B; attacks (without treatment or with ineffective treatment) occurring exclusively on day 1 ± 2 (i.e., days -2 to +3) of menstruation, in at least two of three menstrual cycles; and, additionally, at other times during the cycle
Exclusion criteria
Exclusion criteria: Peak cardiovascular disease or severe cardiopulmonary disease; with sequelae of neurological diseases; who use walking aids; who have visual and auditory impairments; amputations of lower and upper limbs; rheumatic diseases in the acute phase; cancer; epilepsy; fractures of the skull, cervical spine or rib cage; severe osteoporosis; use of a pacemaker and implantable cardioverter-defibrillator; who have undergone surgery less than 1 year ago; who have had a seizure in the last 1 year; pregnant or breastfeeding women
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the reduction in frequency and intensity of headaches in the intervention group compared to the sham group, using the Brief Pain Inventory and Pain Diary, considering a 2- point reduction in pain as a clinically significant outcome and a 50% reduction in frequency as a clinically significant outcome | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
BR
Contacts
Public ContactSynthia Marcolano
Universidade Federal do Espírito Santo
Outcome results
None listed