Study period | ||||||
Enrolment (week) | Allocation (week) | Treatment phase (week) | Follow-up (week) | |||
Time point | −4 | 0 | 4 | 8 | 12 | 16 |
Enrolment | ||||||
Eligibility screen | × | |||||
Informed consent | × | |||||
Physical examination | × | |||||
Randomisation | × | |||||
Interventions | ||||||
Experimental group (CAT group) | × | × | ||||
Control group 1 (IAT group) | × | × | ||||
Control group 2 (sham acupuncture group) | × | × | ||||
Assessments | ||||||
Headache diary | × | × | × | × | × | × |
VAS | × | × | × | × | × | |
MSQ | × | × | × | × | × | |
MIDAS | × | × | × | × | × | |
HIT6 | × | × | × | × | × | |
PSQI | × | × | × | × | × | |
Blinding/credibility test | × | × | ||||
Participants’ safety | ||||||
AE | × | × | × | × | ||
Laboratory test* | × | × | × |
*The laboratory test includes complete blood count and differential count, absolute neutrophil count, aspartate aminotransferase, alanine aminotransferase, total bilirubin, blood urea nitrogen, creatinine, albumin and coagulation test.
AE, adverse event; CAT, contralateral acupuncture; HIT6, Headache Impact Test-6; IAT, ipsilateral acupuncture; MIDAS, Migraine Disability Assessment; MSQ, Migraine-Specific Quality of Life Questionnaire; PSQI, Pittsburgh Sleep Quality Index; VAS, Visual Analogue Scale.