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

NCT ID: NCT06584409

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-07
• Study Completion Date: 2027-12-01

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.

Conditions

Headache, Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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)

Group Type: EXPERIMENTAL

Laser Pen

Intervention Type: DEVICE

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)

Sham treatment

CM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output.

Group Type: SHAM_COMPARATOR

Observation

Intervention Type: OTHER

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.

Interventions

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)

Intervention Type: DEVICE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chi-Hsiang Chou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Taichung Veterans General Hospital

Chi Sheng Wang, M.D.

Role: STUDY_DIRECTOR

Taichung Veterans General Hospital

Huan Yun Wu, M.D.

Role: STUDY_DIRECTOR

Taichung Veterans General Hospital

Locations

Taichung Veterans General Hospital

Taichung, Taichang, Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Yuan-Chen Liu, M.D.

Role: CONTACT

jordan810701@gmail.com

886-972199271

Ching-Chun Chung, M.D.

Role: CONTACT

gracechung1015@gmail.com

886-988566621

Facility Contacts

Yuan-Chen Liu

Role: primary

886-4-2359-2525 ext. 82641

Other Identifiers

CF24162B

Identifier Type: -

Identifier Source: org_study_id