Migraine Without AuraPhase 1NCT07068815
Efficacy and Mechanism of Fu's Subcutaneous Needling Treatment for Migraine Without Aura
A Phase 1 study testing Fu's Subcutaneous Needling and Flunarizine Hydrochloride in people with Migraine Without Aura, run by Guangzhou University of Chinese Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Migraine Without Aura
- What is being tested?
- Fu's Subcutaneous Needling and Flunarizine Hydrochloride
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jun 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fu's Subcutaneous Needling Treatment for Migraine Without Aura: A Randomized Controlled Trial Protocol
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
- Being tested
- Fu's Subcutaneous Needling, Flunarizine Hydrochloride
- Keywords
- Fu's Subcutaneous Needling, migraine without aura, flunarizine hydrochloride
- Medical subject headings
- Migraine without Aura
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fu's Subcutaneous NeedlingDevice
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 HydrochlorideDrug
Participants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Subjected to FSN monotherapy | Experimental | Participants in the FSN group received FSN treatment twice weekly for four weeks. Receives: 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. Receives: Drug: Flunarizine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
Scored from 0 to 10, with higher scores indicating more severe pain.
Measured: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Secondary outcomes (2)
Migraine-Specific Quality of Life (MSQOL)
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.
Measured: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Headache diaries
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).
Measured: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine Without AuraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guo Wenqi, Guangzhou University of Chinese Medicine
- Investigators
- Jian Sun, M.D., Principal investigator, Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07068815
- Sponsor's protocol ID
- YF2025-127
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 16 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fu's Subcutaneous Needling Treatment for Migraine Without Aura: A Randomized Controlled Trial Protocol
- ClinicalTrials.gov ID
- NCT07068815
- Acronym / sponsor ID
- YF2025-127
- Conditions
- Migraine Without Aura
- Keywords
- Fu's Subcutaneous Needling, migraine without aura, flunarizine hydrochloride
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Guangzhou University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 16 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Subjected to FSN monotherapy | Experimental | Device: Fu's Subcutaneous NeedlingParticipants in the FSN group received FSN treatment twice weekly for four weeks. |
| Control group: Treated with oral flunarizine hydrochloride | Active comparator | Drug: Flunarizine HydrochlorideParticipants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fu's Subcutaneous NeedlingParticipants 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. | Device | Experimental group: Subjected to FSN monotherapy |
| Flunarizine HydrochlorideParticipants in the drug group were administered 5 mg flunarizine hydrochloride capsules nightly before sleep for 4 weeks. | Drug | Control group: Treated with oral flunarizine hydrochloride |
Primary outcome
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.
2 secondary outcomes
Migraine-Specific Quality of Life (MSQOL)
Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Headache diaries
Time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jian Sun, M.D. principal investigator
Guangzhou University of Chinese Medicine - Department of Acupuncture and Rehabilitation Clinical Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Fu's Subcutaneous Needling and Flunarizine Hydrochloride in people with Migraine Without Aura, run by Guangzhou University of Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenqi Guo, M.M. (13787352592, 13787352592@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) (time frame: baseline, day 28 of treatment, and follow-up (days 28, 56, and 84 post-treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2025.