Laser Acupuncture for Chronic Migraine

NCT06219694 | Recruiting DMC

• 1 other identifier: CF22082B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Chronic Migraine

Keywords

Migraine; Chronic Migraine; laser acupuncture; Prevention

Outcome Measures

Primary Outcomes (2)

• monthly migraine days

  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

  change in acute headache medications usage days per month from baseline and each follow-up time point

  12 weeks, 24 weeks, 36 weeks

Secondary Outcomes (6)

• 30% reduction in migraine days

  12 weeks, 24 weeks, 36 weeks

• headache duration

  12 weeks, 24 weeks, 36 weeks

• headache severity

  12 weeks, 24 weeks, 36 weeks

• the MIDAS score

  12 weeks

• Hospital Anxiety and Depression Scale (HADS)

  12 weeks

Study Arms (2)

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)

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.

Device: Sham

Interventions

Laser Acupuncture 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)

laser acupuncture

Sham DEVICE

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.

Sham treatment

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Xitun District, 40705, Taiwan

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Yuan-Chen Liu, M.D

  Taichung Veterans General Hospital

  STUDY DIRECTOR

• Ching-Chun Chung, M.D

  Taichung Veterans General Hospital

  STUDY DIRECTOR

Central Study Contacts

ChiSheng Wang, M.D

CONTACT

+886933375721; sam7227632@gmail.com

Chi-Hsiang Chou, M.D

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants were randomized by computer software (Excel 2016 for Windows) and the randomization process was overseen by the Institutional Review Board at Taichung Veterans General Hospital. All the participants and our collaborative case-manager were blinded to treatment types.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 23, 2024
• Study Start: January 1, 2022
• Primary Completion: May 4, 2022
• Study Completion: December 1, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)