NCT06584409 Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP
| NCT ID | NCT06584409 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Taichung Veterans General Hospital |
| Condition | Headache, Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-04-07 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-04-07 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Aims: To investigate the efficacy of laser-acupuncture for the severity of primary headache and comorbidities, and the Lab data examination. Methods: In this hospital-based prospective single blind randomized sham-controlled study, patients over 18 years old with primary headache will be randomly divided into two treatment arms including laser-acupuncture and sham-controlled group. The expected laser-acupuncture protocol will be bilateral BL2, GB20, EX-HN5, GB8, LI4, LR3 and midline EX-HN3 in totally eight sessions at the first month. In the sham-laser-acupuncture group, patients will receive eight sessions of laser-acupuncture for free after unblinding. We expected to track patients for at least half year. The diagnosis and classification of headache was evaluated using the ICHD-3 criteria. The severity of headache was evaluated using Migraine Disability Assessment (MIDAS) and headache diary provided by Taiwan Headache Society. The co-primary efficacy end points are change in migraine days per month and variation of MIDAS. The secondary end point is the reducing of the severity of comorbidities including headache related anxiety and depression, and both of the quality of life and sleep. In addition, patients' characteristics will be investigated as follows: 1. Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure) 2. Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle) 3. Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS) 4. Depression, evaluate by Beck's Depression Inventory 5. Quality of life, evaluate by 36-Item Short Form Survey (SF-36) 6. Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI) 7. Aura of headache 8. Episodic or chronic headache (If patient diagnosed as migraine.) 9. Nausea, vomiting, photophobia, phonophobia (If patient diagnosed as migraine.) During the following time, we will need the patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin. Importance: In our hospital, we perform laser-acupuncture for patients with headache for several years. A prospective randomized controlled study is the key tools to establish the efficacy of laser-acupuncture for primary headache, and the Lab data with MMP2, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.
Eligibility Criteria
Inclusion Criteria: * Migraine patient under the diagnosis and classification of headache was evaluated using the ICHD-3 criteria. Exclusion Criteria: * Age under 18 years old * Pregnancy
Contact & Investigator
Chi-Hsiang Chou, M.D.
PRINCIPAL INVESTIGATOR
Taichung Veterans General Hospital
Frequently Asked Questions
Who can join the NCT06584409 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Headache, Migraine. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06584409 currently recruiting?
Yes, NCT06584409 is actively recruiting participants. Contact the research team at jordan810701@gmail.com for enrollment information.
Where is the NCT06584409 trial being conducted?
This trial is being conducted at Taichung, Taiwan.
Who is sponsoring the NCT06584409 clinical trial?
NCT06584409 is sponsored by Taichung Veterans General Hospital. The principal investigator is Chi-Hsiang Chou, M.D. at Taichung Veterans General Hospital. The trial plans to enroll 60 participants.
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