Clinical trial NCT06584409: Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP
Official title: The Comparsion of Primary Headache in Blood Test of MMP2 and CGRP: A Single Blind Randomized Sham-laser-acupuncture Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The patients was divided to sham group or laser acupuncture group. After 1 months treatment, and followed up for 6 months., the sham group received complementary laser acupuncture for 1 months and followed up for another 3 months.
Primary purpose: TREATMENT

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 Beck's 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 patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.

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, CGRP, substance P, beta-endorphin 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.

It's 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, CGRP, substance P, beta-endorphin 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 Beck's 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 patient's blood samples four times, each times 20cc, all need 80cc for Lab test of MMP2, CGRP, substance P, beta-endorphin.

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, CGRP, substance P, beta-endorphin for approval. Look forward to help improve therapeutic strategies in clinical practice.

Eligibility criteria: Inclusion Criteria:

* Migraine patient under the diagnosis and classification of headache was evaluated using the ICHD-3 criteria.

Exclusion Criteria:

* Age under 18 years old
* Pregnancy

Primary outcomes:
measure: cGRP
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: MMP2
timeFrame: 12 weeks, 24 weeks, 36 weeks
Secondary outcomes:
measure: Difference in the number of headache days per month
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Difference in the of headache attacks lasting hours per month
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Difference in the headache pain intensity (NRS)
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Difference in the number of days with acute headache medication intake per month
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Difference in the Migraine Disability Assessment
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Difference in the Beck's Depression Inventory
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Difference in the Hospital Anxiety and Depression Scale
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: 30% reduction in migraine days
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: Substance P
timeFrame: 12 weeks, 24 weeks, 36 weeks
measure: beta-endorphin
timeFrame: 12 weeks, 24 weeks, 36 weeks
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
state: Taichang
Study officials:
affiliation: Taichung Veterans General Hospital
name: Chi-Hsiang Chou, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Taichung Veterans General Hospital
name: Chi Sheng Wang, M.D.
role: STUDY_DIRECTOR
affiliation: Taichung Veterans General Hospital
name: Huan Yun Wu, M.D.
role: STUDY_DIRECTOR
References: