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

Not Applicable

Not yet recruiting

• Conditions: Migraine Without Aura
• Interventions: Device: Fu's Subcutaneous Needling; Drug: Flunarizine Hydrochloride

• Registration Number: NCT07068815
• Lead Sponsor: Guangzhou University of Chinese Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-07-15
• Last Update Submitted: 2025-07-15
• Study First Posted: 2025-07-16
• Last Update Posted: 2025-07-16
• Study Start: 2025-09-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Meeting the diagnostic criteria for migraine without aura (MwoA) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) ;
2. Aged 18-65 years;
3. A history of migraine for at least 1 year;
4. At least 2 migraine attacks per month;
5. No prophylactic medications or other treatments for migraine within the past month;
6. Visual Analog Scale (VAS) score > 3;
7. Willing and capable of providing written informed consent.

Exclusion Criteria

1. Diagnosed with other primary headaches such as neuropathic headache, cluster headache, or tension-type headache;
2. Comorbid secondary headaches or other neurological disorders (e.g., headache due to anxiety, depression, Parkinson's disease, or intracranial lesions);
3. 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;
4. Comorbid uncontrolled psychiatric disorders;
5. Pregnancy, lactation, or women in the preparation, menstrual, or menopausal phase;
6. Use of prophylactic medications or other treatments for migraine within the past month;
7. History of allergy to the trial medications or contraindications to flunarizine hydrochloride or ibuprofen;
8. Skin lesions at the FSN operation site;
9. Occupations involving driving, working at heights, or other high-risk activities;
10. Refusal to undergo FSN therapy or oral flunarizine hydrochloride.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group: Subjected to FSN monotherapy	Fu's Subcutaneous Needling	Participants in the FSN group received FSN treatment twice weekly for four weeks.
Control group: Treated with oral flunarizine hydrochloride	Flunarizine Hydrochloride	Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)	Scored from 0 to 10, with higher scores indicating more severe pain.

Secondary Outcome Measures

Name	Time	Method
Migraine-Specific Quality of Life (MSQOL)	baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)	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	baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)	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).