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.
Meeting the diagnostic criteria for migraine without aura (MwoA) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) ;
Aged 18-65 years;
A history of migraine for at least 1 year;
At least 2 migraine attacks per month;
Diagnosed with other primary headaches such as neuropathic headache, cluster headache, or tension-type headache;
Comorbid secondary headaches or other neurological disorders (e.g., headache due to anxiety, depression, Parkinson's disease, or intracranial lesions);
Uncontrolled or undiagnosed systemic diseases that may interfere with the study, including severe hepatic, renal, cardiovascular, or cerebrovascular diseases; poorly controlled or untreated hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); poorly controlled or untreated diabetes mellitus; malnutrition; hyperthyroidism; or hepatic insufficiency;
Comorbid uncontrolled psychiatric disorders;
Parallel
Fu's Subcutaneous Needling
DeviceParticipants 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.
Flunarizine Hydrochloride
DrugParticipants 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.
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.
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).
Near-Infrared Spectroscopy (NIRS) Imaging
Participants sat upright with the PortaLite secured over the affected PFC, positioned according to the Fp1/Fp2 landmarks of the international 10-20 EEG system . Sampling frequency was set at 50 Hz, and optodes were shielded with black cloth to minimize ambient light interference. After a 5-minute eyes-closed resting adaptation period to stabilize physiological baselines, a 2-minute resting-state recording was obtained. Following Fu's subcutaneous needling insertion into the upper trapezius (three needle sets with retention), a 5-minute post-treatment resting-state recording was acquired. Additional Fu's subcutaneous needling was administered to other target muscles post-measurement.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
