Phase-specific sequential press-needle therapy for menstrual migraine: a randomized trial protocol
Abstract
Background: Menstrual migraine (MM) is a neurological disorder affecting women of childbearing age. According to the definition in the International Classification of Headache Disorders, 3rd Edition (ICHD-3), it includes pure menstrual migraine (PMM) and menstrually-related migraine (MRM). The efficacy and safety of acupressure therapy for menstrual migraine have not yet been fully evaluated, particularly when administered sequentially according to specific phases of the menstrual cycle. Therefore, we designed this trial to preliminarily assess whether sequential acupressure therapy shows a favorable trend in efficacy compared with oral naproxen sodium, and to evaluate its feasibility, safety, and tolerability, thereby providing baseline data for future large-scale confirmatory trials.
Methods: This is a randomized, active-controlled, parallel-group trial. A total of 76 eligible women aged 18-45 years with migraine without aura and diagnosed with pure menstrual migraine or menstrually-related migraine will be recruited and randomly allocated to receive either sequential press-needle therapy or oral naproxen sodium therapy. In the press-needle group, treatment is delivered at designated acupoints across two phases (pre-menstrual and post-menstrual) per menstrual cycle. Each phase includes 2 sessions with a 2-day interval (4 sessions per cycle), repeated for 3 consecutive cycles. In the control group, oral naproxen sodium (550 mg twice daily after breakfast and dinner) is…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 76 participants or records.
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