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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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
• Препарат Flunarizine Hydrochloride
  Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)]

Вторичные конечные точки (2)

• Migraine-Specific Quality of Life (MSQOL) [Срок оценки: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)]
• Headache diaries [Срок оценки: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07068815 · YF2025-127

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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