Fu’s Subcutaneous Needling treatment for migraine without aura: a randomized controlled trial protocol

Introduction: Fu's Subcutaneous Needling (FSN) is a novel acupuncture technique that has demonstrated significant efficacy in pain management. However, its effectiveness in treating migraine without aura (MWoA) has not been systematically validated. Therefore, this study aims to evaluate the analgesic efficacy of FSN and its impact on headache frequency and patients' quality of life (QoL) in comparison with guideline-recommended pharmacotherapy (flunarizine hydrochloride). Additionally, this study will assess the influence of FSN on hemodynamic changes in the prefrontal cortex to further elucidate its underlying mechanisms. Methods: This study is a randomized controlled clinical trial involving 44 participants, who are randomly allocated at a 1:1 ratio to either the FSN group or the medication group. Participants in the FSN group receive FSN treatment twice weekly for 4 weeks, while those in the medication group are administered 5 mg oral flunarizine hydrochloride capsules nightly for the same duration. Both groups are followed up for 3 months post-treatment. The primary outcome is the change in monthly migraine days (MMDs). From baseline after 4 weeks of treatment. Secondary outcome measures including the Migraine-Specific Quality of Life (MSQOL) score, headache diary records, Migraine Disability Assessment (MIDAS), Visual Analog Scale (VAS) scores and near-infrared spectroscopy (NIRS) are also used to validate clinical efficacy.