This study aimed to compare the analgesic efficacy and quality-of-life improvement between FSN and flunarizine hydrochloride in patients with migraine without aura. The core research questions addressed were: Q1: Whether FSN demonstrates superior or at least equivalent therapeutic effects compared to the active control drug (flunarizine hydrochloride) in pain relief and quality-of-life enhancement for migraine without aura patients; Q2: To elucidate the mechanism of FSN in treating migraine without aura from a cerebral hemodynamic perspective. Participants will:1. Group allocation: A randomized design was employed, with 30 participants enrolled per group. 2. Interventions: Experimental group: Subjected to FSN monotherapy; Control group: Treated with oral flunarizine hydrochloride. 3. Treatment duration: All participants received a 4-week therapeutic intervention. 4. Outcome measures: The following parameters were systematically evaluated during treatment and follow-up: Visual Analog Scale (VAS) scores 、Migraine-Specific Quality of Life (MSQOL) scores、Near-infrared spectroscopy (NIRS) examinations.Researchers will compare FSN to flunarizine hydrochloride(a clinically established medication) to see if FSN exhibits superior or non-inferior efficacy to treat migraine without aura.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Participants were seated while the practitioner identified affected muscles (sternocleidomastoid, scalene, splenius capitis, and upper trapezius) via sliding palpation. After routine disinfection, a disposable FSN needle (Nanjing Paifu Medical Technology Co., Ltd., Jiangsu, China) was inserted parallel to the subcutaneous loose connective tissue surrounding the affected muscle. Once fully inserted, the soft tube stand was secured in the slot. After confirming no pain, the practitioner performed smooth, gentle, fan-shaped swaying movements (120° angle, \~100 times/min) with the index and ring fingers. This was accompanied by reperfusion activities-resistance-based contraction and relaxation of the affected muscles, performed collaboratively by the practitioner and participant. Each set comprised 20 swaying movements and 10 seconds of reperfusion, repeated three times per muscle.
Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.
Visual Analog Scale (VAS)
Scored from 0 to 10, with higher scores indicating more severe pain.
Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Migraine-Specific Quality of Life (MSQOL)
including three dimensions: functional limitations, dysfunction, and emotional impact, assessed via 14 items on a 6-point scale (0-5). Scores were calculated for each dimension.
Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Headache diaries
recording daily migraine episodes, including presence/absence of headache, frequency, average duration, and use of acute analgesics (if taken, drug name, dosage, and frequency were documented).
Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
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