Enhancing Chronic Migraine Preventive Therapy: Laser Acupuncture as an Add-On Treatment for Patients With Unsatisfactory Pharmacological Effect, a Pilot Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Taichung Veterans General Hospital
RECRUITING
Taichung
Contact Information
Primary
ChiSheng Wang, M.D
sam7227632@gmail.com
+886933375721
Backup
Chi-Hsiang Chou, M.D
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2025-12-01
Participants
Target number of participants: 60
Treatments
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)
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.
Related Therapeutic Areas
Sponsors
Leads: Taichung Veterans General Hospital

This content was sourced from clinicaltrials.gov