Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06398353
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2024-03-18
Brief Title:
Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
Sponsor:
Chang Gung Memorial Hospital
Organization:
Chang Gung Memorial Hospital
Study Overview
Official Title:
Investigating the Impact of Acupuncture on the Quality of Life of Primitive Headaches Patients
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary headache is one of the most common neurological diseases in modern society which seriously affects the patients 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None