Laser Acupuncture for Chronic Migraine (LAFCM)

November 17, 2025 updated by: Taichung Veterans General Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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:

  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.)

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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Chi-Hsiang Chou, M.D

Study Locations

  • Taiwan
    • Xitun District
      • Taichung, Xitun District, Taiwan, 40705
        • Recruiting
        • Taichung Veterans General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: laser acupuncture
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 Acupuncture
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 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.
Device: Sham

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 weeks, 24 weeks, 36 weeks
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
12 weeks, 24 weeks, 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the MIDAS score
Time Frame: 12 weeks
changes in the MIDAS score between baseline and each follow-up time point
12 weeks
30% reduction in migraine days
Time Frame: 12 weeks, 24 weeks, 36 weeks
≥ 30% reduction in migraine days between baseline and each follow-up time point
12 weeks, 24 weeks, 36 weeks
headache duration
Time Frame: 12 weeks, 24 weeks, 36 weeks
changes in the headache duration between baseline and each follow-up time point
12 weeks, 24 weeks, 36 weeks
headache severity
Time Frame: 12 weeks, 24 weeks, 36 weeks
changes in the headache severity (based on NRS) between baseline and each follow-up time point
12 weeks, 24 weeks, 36 weeks
Hospital Anxiety and Depression Scale (HADS)
Time Frame: 12 weeks
change in HADS score between baseline and each follow-up time point
12 weeks
Beck's Depression Inventory
Time Frame: 12 weeks
change in BDI score between baseline and each follow-up time point
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taichung Veterans General Hospital

Investigators

  • Study Director: Yuan-Chen Liu, M.D, Taichung Veterans General Hospital
  • Study Director: Ching-Chun Chung, M.D, Taichung Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

May 4, 2022

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 3, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

November 20, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CF22082B

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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