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NCT Number: NCT07068815

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

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.

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Key information

Conditions

Migraine Without Aura Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fu's Subcutaneous Needling

Device

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 smooth, gentle, fan-shaped swaying movements (120° angle, ~100 times/min) with the index and ring fingers. This was accompanied by reperfusion activities-resistance-based contraction and relaxation of the affected muscles, performed collaboratively by the practitioner and participant. Each set comprised 20 swaying movements and 10 seconds of reperfusion, repeated three times per muscle.

Flunarizine Hydrochloride

Drug

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

Primary outcomes

  1. Visual Analog Scale (VAS)

    Time frame: 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.

Secondary outcomes

  1. Migraine-Specific Quality of Life (MSQOL)

    Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)

    including three dimensions: functional limitations, dysfunction, and emotional impact, assessed via 14 items on a 6-point scale (0-5). Scores were calculated for each dimension.

  2. Headache diaries

    Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)

    recording daily migraine episodes, including presence/absence of headache, frequency, average duration, and use of acute analgesics (if taken, drug name, dosage, and frequency were documented).

Other outcomes

  1. Near-Infrared Spectroscopy (NIRS) Imaging

    Time frame: The 1st, 8th, 15th and 22nd day after the start of the treatment.

    Participants sat upright with the PortaLite secured over the affected PFC, positioned according to the Fp1/Fp2 landmarks of the international 10-20 EEG system . Sampling frequency was set at 50 Hz, and optodes were shielded with black cloth to minimize ambient light interference. After a 5-minute eyes-closed resting adaptation period to stabilize physiological baselines, a 2-minute resting-state recording was obtained. Following Fu's subcutaneous needling insertion into the upper trapezius (three needle sets with retention), a 5-minute post-treatment resting-state recording was acquired. Additional Fu's subcutaneous needling was administered to other target muscles post-measurement.

Study contacts

Contact information is provided by the study sponsor or research team.

Wenqi Guo, M.M.

CONTACT

[email protected]

13787352592

Sponsors and collaborators

Lead sponsor

Guangzhou University of Chinese Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 16, 2025
Registry last updated
Jul 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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