Laser Acupuncture for Chronic Migraine

Not Applicable

Completed

Brief 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.

Detailed 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 & 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.

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
monthly migraine days	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	12 weeks, 24 weeks, 36 weeks	change in acute headache medications usage days per month from baseline and each follow-up time point

Secondary Outcome Measures

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

Locations (1): Taichung Veterans General Hospital
🇨🇳
Taichung, Xitun District, Taiwan

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