Clinical trial NCT06398353: Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
Official title: Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Headache Migraine
Keywords: Headache
Migraine
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-05-03
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Detailed description: In this study, 120 subjects who already suffered from headache symptoms (such as dizziness, heavy head, lightheadedness, head fullness, migraine) were treated with acupuncture at acupuncture points, and the pulse diagnosis instrument was used to capture the subjects' symptoms during acupuncture. The pulse waves before and after are collected, compared and analyzed to complete this test.

After the subjects are accepted, they will go to the Acupuncture and Traumatology Department of the Department of Traditional Chinese Medicine of Chang Gung Memorial Hospital (Taoyuan Branch) at an agreed time for health education and filling out questionnaires. After filling out the questionnaire, participants can reserve a time for the test.

One person is tested each time, and each test lasts 70-80 minutes. Pulse waves are collected for 20 minutes before and after the test. The acupuncture treatment plan for each subject in this study was based on traditional Chinese medicine theory and published literature. The acupuncture points selected were bilateral Cuanzhu, Taiyang, Tianzhu, Fengchi, Baihui, Hegu, Neiting, Zusanli, Waiguan, and Zulin. Qi, Houxi, Shenmai, Taichong. The doctor will select the above 4-6 acupoints according to the disease. It is divided into an acupuncture group and a sham acupuncture group. Before the experiment, first fill out the questionnaire. This trial is divided into an acupuncture group and a sham acupuncture group. A crossover design is adopted. 50% of the subjects will be assigned to the acupuncture group first. Then they will be connected to the sham acupuncture group, and the other 50% of the subjects will be assigned to the sham acupuncture group first and then the acupuncture group. Each group will last for two weeks, and acupuncture will be performed twice a week at the set acupuncture points. The first group of acupuncture will end. , will be interrupted for two weeks, and then another set of tests will be conducted, and then the patient will go to Chang Gung Memorial Hospital Taoyuan Branch for the final scale and quality of life questionnaire. The total trial period was eight weeks.

While undergoing the test, try to avoid taking Chinese and Western medicines and alcoholic beverages to avoid interfering with the study. (If participants usually take antihypertensive drugs and heart drugs, participants can continue to take them.) After the test, participants should drink more warm water and get enough rest. Do not take a shower or touch or drink cold things.

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.

Primary outcomes:
measure: Numerical rating scale
timeFrame: 2 minutes
measure: The Depression, Anxiety and Stress Scale (DASS-21),
timeFrame: 7minutes
measure: Europe health-related quality of life questionnaire 5 dimensions (EQ-5D)
timeFrame: 7minutes
measure: The headache diary
timeFrame: 20minutes
measure: Migraine Disability Assessment Questionnaire (MIDAs)
timeFrame: 7minutes
measure: The Taiwan Short Form 36 Health Scale (SF-36)
timeFrame: 20minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
state: Select A State
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chien-Chung YANG
role: STUDY_DIRECTOR
References: