NCT07068815

Efficacy and Mechanism of Fu's Subcutaneous Needling Treatment for Migraine Without Aura

Fu's Subcutaneous Needling Treatment for Migraine Without Aura: A Randomized Controlled Trial Protocol

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Guangzhou University of Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Migraine Without Aura

Interventions

Type	Name	Description
DEVICE	Fu's Subcutaneous Needling	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.
DRUG	Flunarizine Hydrochloride	Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-07-16
• Last updated: 2025-07-16