Fu's Subcutaneous Needling Treatment for Migraine Without Aura: A Randomized Controlled Trial Protocol
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Visual Analog Scale (VAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Experimental group: Subjected to FSN monotherapy
Participants in the FSN group received FSN treatment twice weekly for four weeks.
干预措施: Fu's Subcutaneous Needling (Device)
Control group: Treated with oral flunarizine hydrochloride
Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.
干预措施: Flunarizine Hydrochloride (Drug)
结局指标
主要结局
Visual Analog Scale (VAS)
时间窗: 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.
次要结局
- Migraine-Specific Quality of Life (MSQOL)(baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment))
- Headache diaries(baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment))
研究者
Guo Wenqi
Principal Investigator
Guangzhou University of Chinese Medicine