Period | Baseline | Treatment phase | Follow-up phase | ||||
---|---|---|---|---|---|---|---|
Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
Week | -4 | 1 to 4 | 8 | 12 | 16 | 20 | 24 |
Informed consent | × | ||||||
Demographic characteristics | × | ||||||
Medical history | × | ||||||
Laboratory tests, electrocardiography, pregnancy test | × | ||||||
Inclusion/exclusion criteria | × | ||||||
Vital signs | × | × | × | × | × | × | × |
Change of medical history | × | × | × | × | × | × | × |
Random allocation | × | ||||||
Acupuncture | ⊗ | ||||||
Headache diary | × | × | × | × | × | × | × |
Visual analog scale | × | × | × | × | × | × | × |
Headache intensity grade | × | × | × | × | × | × | × |
Migraine-specific Quality-of-Life Questionnaire | × | × | |||||
Zung Self-rating Anxiety Scale | × | × | |||||
Zung Self-rating Depression Scale | × | × | |||||
Acupuncture Expectancy Questionnaire | × | ||||||
Safety assessment | × |