Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache (NCT07633522) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fire Needling Plus Filiform Needling for Chronic Migraine With Comorbid Tension-Type Headache
China88 participantsStarted 2026-08
Plain-language summary
The investigators conducted a multicenter, prospective, randomized controlled clinical study to learn whether fire needling combined with filiform needling applied to pericranial muscle tenderness areas can effectively treat chronic migraine with comorbid tension-type headache. The study will also evaluate the safety and long-term efficacy of this therapy. Its main target questions include:
1. Can fire needling significantly reduce the number of headache days per month?
2. What is the effect of this therapy on headache intensity, emotional symptoms, and quality of life? The investigators will compare "fire needling at pericranial tender points plus conventional filiform needling" versus "conventional filiform needling alone" to verify whether the key technique of fire needling plus conventional filiform needling provides unique additive value.
Participants will:
1. Receive treatment twice per week for 8 weeks (either in the experimental group or the control group)，attend a follow-up visit at week 24 after enrollment
2. Keep a headache diary (recording headache frequency, pain intensity, duration, associated symptoms, etc.)
3. Regularly complete assessments of emotional status, quality of life, and number of pericranial tender points
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Meets the diagnostic criteria for tension-type headaches with pericranial tenderness;
* Meets the diagnostic criteria for chronic migraine;
* 18 years ≤ age ≤ 65 years;
* Has sufficient understanding to complete the necessary examinations and tests for the study;
* Voluntarily joins this study and signs the informed consent form.
Exclusion Criteria:
* Patients complicated with cluster headache or other primary headaches;
* Patients with secondary headaches caused by intracranial space-occupying lesions, cranial infections, etc.;
* Patients complicated with severe heart, liver or kidney impairment, coagulation disorders, infections, severe immunocompromise, or allergic predisposition;
* Patients with alcohol or drug dependence;
* Patients who are unable to cooperate with acupuncture treatment;
* Women who are planning pregnancy, pregnant or breastfeeding;
* Patients who have received acupuncture treatment within 3 months prior to enrollment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Treatment efficacy
Timeframe: At week 8 of treatment, and follow-up at week 24 of enrollment
Trial details
NCT IDNCT07633522
SponsorBeijing Hospital of Traditional Chinese Medicine