Chronic MigraineLAFCMNCT06219694
Laser Acupuncture for Chronic Migraine
A study testing Laser Acupuncture in people with Chronic Migraine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
A single-blind randomized controlled trial was conducted from October 2024 to May 2025. Chronic migraine patients were randomly assigned in a 1:1 ratio to receive either Laser acupuncture or sham treatment. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chronic Migraine
- What is being tested?
- Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients aged above 20 years old and had CM managed pharmacologically, including preventive and/or acute migraine medications, and in addition, those who had refused preventive agent despite recommendation of the neurologist;
- patients who had unsatisfactory effect of current pharmacological treatments, defined as they self-reported
- patients who had a minimum of one-year history of migraine with or without aura.
Who cannot join
- patients who had received another LA therapy or traditional acupuncture at baseline
- migraine onset after the age of 50
- cognitive or psychological impairment interfering with the participant's ability to receive LA protocol and describe symptoms
- patients with missing data at baseline or during the follow-up period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chi-Hsiang Chou, M.D contact
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, Xitun District, 40705
Chi-Sheng Wang, MD, +886933375721, sam7227632@gmail.com
About this study
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
A single-blind randomized controlled trial was conducted from October 2024 to May 2025. Chronic migraine patients were randomly assigned in a 1:1 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 Beck's Depression Inventory(BDI) evaluation. Evaluations were taken at baseline and each follow-up point.
After >6 months follow up as washing out time, 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).
Read the 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.
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:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- 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 1:1 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).
- Conditions
- Chronic Migraine
- Being tested
- Laser Acupuncture, Sham
- Keywords
- Migraine, Chronic Migraine, laser acupuncture, Prevention
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AcupunctureDevice
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)
ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| laser acupuncture | Experimental | 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) Receives: Device: Laser Acupuncture |
| Sham treatment | Sham comparator | CM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output. Receives: Device: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
monthly migraine days
change in monthly migraine days (MMD) from baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
acute headache medications usage days
change in acute headache medications usage days per month from baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
Secondary outcomes (6)
30% reduction in migraine days
≥ 30% reduction in migraine days between baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
headache duration
changes in the headache duration between baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
headache severity
changes in the headache severity (based on NRS) between baseline and each follow-up time point
Measured: 12 weeks, 24 weeks, 36 weeks
the MIDAS score
changes in the MIDAS score between baseline and each follow-up time point
Measured: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
change in HADS score between baseline and each follow-up time point
Measured: 12 weeks
Beck's Depression Inventory
change in BDI score between baseline and each follow-up time point
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Jan 2022
- Primary completion4 May 2022
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yuan-Chen Liu, M.D, Study director, Taichung Veterans General HospitalChing-Chun Chung, M.D, Study director, Taichung Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06219694
- Sponsor's protocol ID
- CF22082B
- Acronym
- LAFCM
- Status last verified
- Sep 2025
- First submitted
- 3 Jan 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06219694
- Acronym / sponsor ID
- LAFCM / CF22082B
- Conditions
- Chronic Migraine
- Keywords
- Migraine, Chronic Migraine, laser acupuncture, Prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 23 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single-blind randomized controlled trial was conducted from October 2024 to May 2025. Chronic migraine patients were randomly assigned in a 1:1 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 Beck's Depression Inventory(BDI) evaluation. Evaluations were taken at baseline and each follow-up point.
After >6 months follow up as washing out time, 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.
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.
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:
- Sociodemographic factors (ethnicity, age, sex, body weight, BMI, blood pressure)
- Headache related parameters (onset, duration, pain scale, current medication for headache, menstrual cycle)
- Anxiety, evaluate by Hospital Anxiety and Depression Scale (HADS)
- Depression, evaluate by Beck's Depression Inventory
- Quality of life, evaluate by 36-Item Short Form Survey (SF-36)
- Quality of sleep, evaluate by Pittsburgh Sleep Quality Index (PSQI)
- Aura of headache
- Episodic or chronic headache (If patient diagnosed as migraine.)
- 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 1:1 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| laser acupuncture | Experimental | Device: Laser AcupunctureCM 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) |
| Sham treatment | Sham comparator | Device: ShamCM patients with unsatisfactory pharmacological effects receive sham treatment for 8 sessions that spanned 4 weeks. Sham treatment had no laser output. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients aged above 20 years old and had CM managed pharmacologically, including preventive and/or acute migraine medications, and in addition, those who had refused preventive agent despite recommendation of the neurologist;
- patients who had unsatisfactory effect of current pharmacological treatments, defined as they self-reported
- patients who had a minimum of one-year history of migraine with or without aura.
Key exclusion criteria (4 listed)
- patients who had received another LA therapy or traditional acupuncture at baseline
- migraine onset after the age of 50
- cognitive or psychological impairment interfering with the participant's ability to receive LA protocol and describe symptoms
- patients with missing data at baseline or during the follow-up period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AcupunctureLaser 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 acupuncture |
| ShamSham 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. | Device | Sham treatment |
Primary outcome
monthly migraine days
Time frame: 12 weeks, 24 weeks, 36 weeks
change in monthly migraine days (MMD) from baseline and each follow-up time point
acute headache medications usage days
Time frame: 12 weeks, 24 weeks, 36 weeks
change in acute headache medications usage days per month from baseline and each follow-up time point
6 secondary outcomes
30% reduction in migraine days
Time frame: 12 weeks, 24 weeks, 36 weeks
headache duration
Time frame: 12 weeks, 24 weeks, 36 weeks
headache severity
Time frame: 12 weeks, 24 weeks, 36 weeks
the MIDAS score
Time frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
Beck's Depression Inventory
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi-Hsiang Chou, M.D contact
Yuan-Chen Liu, M.D study director
Taichung Veterans General Hospital
Ching-Chun Chung, M.D study director
Taichung Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture in people with Chronic Migraine, run by Taichung Veterans General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ChiSheng Wang, M.D (+886933375721, sam7227632@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monthly migraine days (time frame: 12 weeks, 24 weeks, 36 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.