Laser Acupuncture for Chronic Migraine

Chronic Migraine Clinical Trial

— LAFCM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06219694
• Other study ID #: CF22082B
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 18, 2023

Study information

• Verified date: March 2024
• Source: Taichung Veterans General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single-blind randomized controlled trial was conducted from January 2022 to September 2023. 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. Evaluations were taken at baseline and each follow-up point.

Description:

Objective We aimed to investigate the efficacy and safety of laser acupuncture (LA) as an add-on preventive therapy on chronic migraine (CM). Methods A single-blind randomized controlled trial was conducted from January 2022 to September 2023. 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. The co-primary outcomes were changes in monthly migraine days (MMD) and acute headache medications usage days per month from baseline. Evaluations were taken at baseline (12 weeks before randomization), at 4th week (treatment completed), 8th week and 12th week from baseline.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 18, 2023
• Est. primary completion date: September 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

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
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)

Locations

Country	Name	City	State
Taiwan	Taichung Veterans General Hospital	Taichung	Xitun District

Sponsors (1)

Lead Sponsor	Collaborator
Taichung Veterans General Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	monthly migraine days	change in monthly migraine days (MMD) from baseline	12 weeks
Primary	acute headache medications usage days	change in acute headache medications usage days per month from baseline	12 weeks
Secondary	30% reduction in migraine days	= 30% reduction in migraine days between baseline and each follow-up time point	12 weeks
Secondary	headache duration	changes in the headache duration between baseline and each follow-up time point	12 weeks
Secondary	headache severity	changes in the headache severity (based on NRS) between baseline and each follow-up time point	12 weeks
Secondary	the MIDAS score	changes in the MIDAS score between baseline and each follow-up time point	12 weeks