Migraines Accepted Laser Acupuncture Compared in Blood Test of MMP2 and CGRP

The Comparsion of Primary Headache in Blood Test of MMP2 and CGRP: A Single Blind Randomized Sham-laser-acupuncture Controlled Study.

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.

Study Overview

• Status: Recruiting
• Conditions: Headache, Migraine
• Intervention / Treatment: Device: Laser Pen; Other: Observation

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yuan-Chen Liu, M.D.; Phone Number: 886-972199271; Email: jordan810701@gmail.com
• Study Contact Backup: Name: Ching-Chun Chung, M.D.; Phone Number: 886-988566621; Email: gracechung1015@gmail.com

Study Locations

• Taiwan
  • Taichang
    • Taichung, Taichang, Taiwan, 404
      • Recruiting
      • Taichung Veterans General Hospital
      • Contact: Yuan-Chen Liu; Phone Number: 82641 886-4-2359-2525

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Sham treatment; CM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output.	Other: Observation; Sham treatment with no laser output, stimulate the same acupoints as laser acupuncture group as follows: 30 seconds at bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3) After 6 months followed up, the sham group received truely Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3), and followed up for another 3 months.
Experimental: Laser treatment; CM patients with unsatisfactory pharmacological effects receive laser acupuncture for 8 sessions that spanned 4 weeks. Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)	Device: Laser Pen; Laser stimulation energy of 4.5 J for 30 seconds at each of the following acupoints: bilateral Cuanzhu (BL2), Fengchi (GB20), Taiyang (EX-HN5), Shuaigu (GB8), Hegu (LI4), Taichong (LR3) and midline Yintang (EX-HN3)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cGRP	change in cGRP from baasline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
MMP2	change in MMP2 from baasline and each follow-up time point	12 weeks, 24 weeks, 36 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the number of headache days per month	change in monthly migraine days (MMD) from baseline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
Difference in the of headache attacks lasting hours per month	change in acute headache medications usage days per month from baseline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
Difference in the headache pain intensity (NRS)	changes in the headache severity (based on NRS) between baseline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
Difference in the number of days with acute headache medication intake per month	change in acute headache medications usage days per month from baseline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
30% reduction in migraine days	≥ 30% reduction in migraine days between baseline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
Difference in the Migraine Disability Assessment	changes in the Migraine Disability Assessmen between baseline and each follow-up time point. Title: Migraine Disability Assessmen Maximum value:450 Minimum value:0 Higher scores mean: worsen outcome	12 weeks, 24 weeks, 36 weeks
Difference in the Beck's Depression Inventory	change in Beck's Depression Inventory between baseline and each follow-up time point Title:Beck's Depression Inventory Maximum value:63 Minimum value:0 Higher scores mean: worsen outcome	12 weeks, 24 weeks, 36 weeks
Difference in the Hospital Anxiety and Depression Scale	change in Hospital Anxiety and Depression Scale between baseline and each follow-up time point Title:Hospital Anxiety and Depression Scale Maximum value:21/21 Minimum value:0/0 Higher scores mean:worsen outcome	12 weeks, 24 weeks, 36 weeks
Substance P	change in Substance P from baasline and each follow-up time point	12 weeks, 24 weeks, 36 weeks
beta-endorphin	change in beta-endorphin from baasline and each follow-up time point	12 weeks, 24 weeks, 36 weeks

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Chi-Hsiang Chou, M.D., Taichung Veterans General Hospital; Study Director: Chi Sheng Wang, M.D., Taichung Veterans General Hospital; Study Director: Huan Yun Wu, M.D., Taichung Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: September 2, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 6, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Headache
• Other Study ID Numbers: CF24162B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No