NCT06398353 Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
| NCT ID | NCT06398353 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chang Gung Memorial Hospital |
| Condition | Headache Migraine |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-01-31 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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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 120 participants in total. It began in 2024-01-31 with a primary completion date of 2027-06-01.
⚠ 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
Primary headache is one of the most common neurological diseases in modern society, which seriously affects the patient's quality of life. Although the use of painkillers can alleviate primary headache symptoms, it may also cause drug dependence. Therefore, alternative therapies that do not rely on drugs have attracted increasing attention in recent years. Among them, acupuncture has been partially recognized by the public as an effective treatment for primary headaches. However, there is currently no scientific evidence that acupuncture is effective for primary headaches. The purpose of this project is to verify the effect of acupuncture in treating primary headaches. This study has three sub-projects: Subproject 2 explores the impact of acupuncture on headache severity and quality of life in patients with primary headaches. We evaluate the quality of life before and after acupuncture treatment through professional questionnaires, including the Numerical rating scale (NRS), headache diary, depression, anxiety and stress scale (DASS-21), health quality of life measurement questionnaire, Migraine Disability Assessment Scale and SF-36 Taiwan version. Finally, these data will be combined with the pulseway analysis from the results of sub-project 1 to provide a comprehensive way to evaluate the treatment effect.
Eligibility Criteria
Inclusion Criteria: 1. Willing to sign a written subject consent form 2. Male or female over 18 years old 3. Those who have headaches (for example: dizziness, heavy head, dizziness, head fullness, migraine), those who have headaches more than twice a week, and whose NRS score is ˃ 4. 4. Headache definition: Headache symptoms are classified according to the ICHD-3 headache classification of the International Headache Organization, and are mainly primary headaches. Dr. Chang ,Y.-J. and Dr. Yang ,C.-C. help to exclude headache patients with the following exclusion conditions to reduce the risk to subjects. Exclusin Criteria 1. Pregnant women 2. Various acute and chronic infectious diseases, various skin ulcers, sores, burns, etc. 3. The patient has injuries to the radial artery or wrist, or has steel nails, plates, or fractures. 4. Various types of headaches related to anatomical structural lesions 5. Headaches associated with taking or withdrawing from substances (drugs, food, or other chemicals) 6. Headaches related to non-head infections and metabolic diseases 7. People with painful cranial neuropathy, other facial pain and other headaches 8. People with secondary headaches according to ICHD-3 beta 9. Other patients who have been evaluated by physicians as not suitable for inclusion in the evaluation.
Contact & Investigator
Chien-Chung YANG
STUDY DIRECTOR
Chang Gung Memorial Hospital
Frequently Asked Questions
Who can join the NCT06398353 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 NCT06398353 currently recruiting?
Yes, NCT06398353 is actively recruiting participants. Contact the research team at r55161@cgmh.org.tw for enrollment information.
Where is the NCT06398353 trial being conducted?
This trial is being conducted at Taoyuan, Taiwan.
Who is sponsoring the NCT06398353 clinical trial?
NCT06398353 is sponsored by Chang Gung Memorial Hospital. The principal investigator is Chien-Chung YANG at Chang Gung Memorial Hospital. The trial plans to enroll 120 participants.
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