Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06219694
Status:
RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-01-03
Brief Title:
Laser Acupuncture for Chronic Migraine
Sponsor:
Taichung Veterans General Hospital
Organization:
Taichung Veterans General Hospital
Study Overview
Official Title:
Enhancing Chronic Migraine Preventive Therapy Laser Acupuncture as an Add-On Treatment for Patients With Unsatisfactory Pharmacological Effect a Pilot Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
LAFCM
Brief Summary:
A single-blind randomized controlled trial was conducted from October 2024 to May 2025 Chronic migraine patients were randomly assigned in a 11 ratio to receive either Laser acupuncture or sham treatment The co-primary outcomes were changes in monthly migraine days MMD and acute headache medications usage days per month from baseline and Hospital Anxiety and Depression Scale HADS and Becks Depression InventoryBDI evaluation Evaluations were taken at baseline and each follow-up point
After 6 months follow up the sham group received complementary laser acupuncture treatment and follow up for another 3 months compared the Headache related parameters onset duration pain scale current medication for headache menstrual cycle
After 6 months follow up the sham group received complementary laser acupuncture treatment and follow up for another 3 months compared the Headache related parameters onset duration pain scale current medication for headache menstrual cycle
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
Aims
We aimed to investigate the efficacy and safety of laser acupuncture LA as an add-on preventive therapy on chronic migraine CM
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
A single-blind randomized controlled trial was conducted from October 2024 to May 2025 CM patients with unsatisfactory pharmacological effects were randomly assigned in a 11 ratio to receive either LA or sham treatment over a course of 8 sessions spanning 4 weeks Evaluations were taken at baseline 12 weeks before randomization at 4th week treatment completed 8th week and 12th week from baseline and follow up till 24th week and the sham group received complementary laser acupuncture treatment and follow up for another 3 months compared the Headache related parameters onset duration pain scale current medication for headache menstrual cycle
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
Aims
We aimed to investigate the efficacy and safety of laser acupuncture LA as an add-on preventive therapy on chronic migraine CM
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
A single-blind randomized controlled trial was conducted from October 2024 to May 2025 CM patients with unsatisfactory pharmacological effects were randomly assigned in a 11 ratio to receive either LA or sham treatment over a course of 8 sessions spanning 4 weeks Evaluations were taken at baseline 12 weeks before randomization at 4th week treatment completed 8th week and 12th week from baseline and follow up till 24th week and the sham group received complementary laser acupuncture treatment and follow up for another 3 months compared the Headache related parameters onset duration pain scale current medication for headache menstrual cycle
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