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

Guangzhou University of Chinese Medicine

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Migraine Without Aura

Treatments: Device: Fu's Subcutaneous Needling; Drug: Flunarizine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT07068815

YF2025-127

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups

Experimental group: Subjected to FSN monotherapy

Experimental group

Description:

Participants in the FSN group received FSN treatment twice weekly for four weeks.

Treatment:

Device: Fu's Subcutaneous Needling

Control group: Treated with oral flunarizine hydrochloride

Active Comparator group

Description:

Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.

Treatment:

Drug: Flunarizine Hydrochloride