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

NCT07068815 | Not Yet Recruiting Phase 1

• 1 other identifier: YF2025-127
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Migraine Without Aura

Keywords

Fu's Subcutaneous Needling; migraine without aura; flunarizine hydrochloride

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale (VAS)

  Scored from 0 to 10, with higher scores indicating more severe pain.

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

Secondary Outcomes (2)

• 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)

Other Outcomes (1)

• Near-Infrared Spectroscopy (NIRS) Imaging

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

Study Arms (2)

Experimental group: Subjected to FSN monotherapy

EXPERIMENTAL

Participants in the FSN group received FSN treatment twice weekly for four weeks.

Device: Fu's Subcutaneous Needling

Control group: Treated with oral flunarizine hydrochloride

ACTIVE COMPARATOR

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

Drug: Flunarizine Hydrochloride

Interventions

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.

Experimental group: Subjected to FSN monotherapy

Flunarizine Hydrochloride DRUG

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

Control group: Treated with oral flunarizine hydrochloride

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou University of Chinese Medicine: lead

MeSH Terms

Conditions

Migraine without Aura

Interventions

Flunarizine

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jian Sun, M.D.

  Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenqi Guo, M.M.

CONTACT

13787352592; 13787352592@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 16, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR