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

Launched by GUANGZHOU UNIVERSITY OF CHINESE MEDICINE · Jul 15, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called Fu's Subcutaneous Needling (FSN) to see if it can help people who have migraines without aura—a type of migraine that doesn’t have warning signs like flashing lights. The study will compare FSN to a commonly used migraine medicine called flunarizine hydrochloride, to find out if FSN works as well or better in reducing migraine pain and improving quality of life. Researchers will also look at how FSN might affect blood flow in the brain to understand how it helps relieve migraines.

Adults aged 18 to 65 who have had migraines without aura for at least a year, with at least two migraine attacks per month, and who haven’t used preventive migraine treatments recently may be eligible to join. Participants will be randomly assigned to receive either FSN therapy or the oral medication for four weeks. During the study, they will regularly rate their pain levels and quality of life, and undergo simple tests to monitor brain blood flow. This trial is not yet recruiting, but if you qualify and decide to participate, you can expect close monitoring and support throughout the treatment period.

Gender

ALL

Eligibility criteria

• 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.