Efficacy and Mechanism of Fu's Subcutaneous Needling Treatment for Migraine Without Aura
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fu's Subcutaneous Needling, Flunarizine Hydrochloride.
- Who it may be relevant to
- Registry conditions: Migraine Without Aura. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Fu's Subcutaneous Needling Treatment for Migraine Without Aura: A Randomized Controlled Trial Protocol
Overview
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.
Interventions
- 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 - Drug Flunarizine Hydrochloride
Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.
Primary outcome measures
- Visual Analog Scale (VAS) [Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)]
Secondary outcome measures (2)
- Migraine-Specific Quality of Life (MSQOL) [Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)]
- Headache diaries [Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)]
Eligibility criteria
Inclusion criteria
- 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;
- No prophylactic medications or other treatments for migraine within the past month;
- Visual Analog Scale (VAS) score > 3;
- Willing and capable of providing written informed consent.
Exclusion criteria
- 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;
- Pregnancy, lactation, or women in the preparation, menstrual, or menopausal phase;
- Use of prophylactic medications or other treatments for migraine within the past month;
- History of allergy to the trial medications or contraindications to flunarizine hydrochloride or ibuprofen;
- Skin lesions at the FSN operation site;
- Occupations involving driving, working at heights, or other high-risk activities;
- Refusal to undergo FSN therapy or oral flunarizine hydrochloride.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07068815 · YF2025-127