Table 2.
Schedule of outcome assessments across study time points.
| Timepoint | Item | ||||
|---|---|---|---|---|---|
| Baseline | Treatment period | Follow-up period | |||
| 1 month | 2 months | 3 months | 3 months post-treatment | ||
| Enrollment | |||||
| Screening for eligibility | √ | ||||
| Informed consent | √ | ||||
| Randomization | √ | ||||
| Intervention | |||||
| Press-needle therapy |
|
||||
| Sham press-needle therapy |
|
||||
| Assessment | |||||
| Primary outcome | |||||
| Headache days (e-diary) | √ | √ | √ | √ | √ |
| Secondary outcome | |||||
| Headache intensity (NRS, e-diary) | √ | √ | √ | √ | √ |
| MMFIQ | √ | √ | √ | √ | √ |
| MSQ v2.1 | √ | √ | √ | √ | √ |
| Acute medication use (e-diary) | √ | √ | √ | √ | √ |
| HRV recording | √ | √ | √ | √ | √ |
| Exploratory outcomes | |||||
| Blood biomarkers (CGRP, E2, P4) | √ | √ | √ | √ | |
| Neuroimaging (subset, MRI) | √ | √ | √ | √ | |
| Other measures | |||||
| Blinding assessment | √ | √ | √ | √ | |
| CEQ | √ | ||||
| Adverse events monitoring | √ | √ | √ | √ | |
| Protocol compliance check | √ | √ | √ | ||
| Concomitant medication review | √ | √ | √ | √ | √ |
NRS, Numeric Rating Scale; MMFIQ, Menstrual Migraine Functional Impact Questionnaire; MSQ, Migraine-Specific Quality of Life Questionnaire; HRV, Heart Rate Variability; CGRP, Calcitonin Gene-Related Peptide; E2, Estradiol; P4, Progesterone. CEQ, Credibility/Expectancy Questionnaire.