Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584409
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Comparsion of Primary Headache in Blood Test of MMP2 and CGRP A Single Blind Randomized Sham-laser-acupuncture Controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Becks 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 patients blood samples four times each times 20cc all need 80cc for Lab test of MMP2 and CGRP
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 and CGRP for approval Look forward to help improve therapeutic strategies in clinical practice
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 Becks 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 patients blood samples four times each times 20cc all need 80cc for Lab test of MMP2 and CGRP
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 and CGRP for approval Look forward to help improve therapeutic strategies in clinical practice
Detailed Description:
Headache is one of the most common complaints encountered in medical institution as known as an almost universal human experience Approximately 65 of headaches are classified as primary which was a composite of migraine tension-type headache trigeminal autonomic cephalalgia and other primary headaches according to the third edition of the International Classification of Headache Disorders ICHD-3 Primary headaches encompass a heterogeneous group of neurologic disorders and might be bothersome for patients
Its well established that acupuncture can be considered a treatment option for migraine prevention The efficacy of laser-acupuncture is similar to acupuncture and laser-acupuncture is a non-invasive therapeutic approach and safety It could reduce the risk of hemorrhage infection and needle phobia However the efficacy of laser-acupuncture in primary headache remains inconclusive
MMP2 and CGRP are new Lab examination for following up the patients suffered from migraine
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 Becks 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 patients blood samples four times each times 20cc all need 80cc for Lab test of MMP2 and CGRP
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 and CGRP for approval Look forward to help improve therapeutic strategies in clinical practice
Its well established that acupuncture can be considered a treatment option for migraine prevention The efficacy of laser-acupuncture is similar to acupuncture and laser-acupuncture is a non-invasive therapeutic approach and safety It could reduce the risk of hemorrhage infection and needle phobia However the efficacy of laser-acupuncture in primary headache remains inconclusive
MMP2 and CGRP are new Lab examination for following up the patients suffered from migraine
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 Becks 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 patients blood samples four times each times 20cc all need 80cc for Lab test of MMP2 and CGRP
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 and CGRP for approval Look forward to help improve therapeutic strategies in clinical practice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None