Auricular neuromodulation by low level laser therapy versus placebo laser therapy in prophylactic treatment of episodic migraine: a randomized controlled study protocol.

Migraine affects over 1 billion people worldwide, and many patients struggle with current preventive medications due to side effects or cost. This study is testing whether a non-invasive laser therapy applied to specific points on the ear can help reduce migraine frequency. The research involves 106 adults who experience 4-15 migraine days per month. Participants receive either real or placebo low-level laser therapy (LLLT) on selected ear points during three sessions, spaced one month apart. The study measures whether patients have fewer migraine days between weeks 9-12 compared to the four weeks before treatment began. This approach is based on auricular neuromodulation, which uses ear stimulation zones similar to those in auricular acupuncture but with a different scientific explanation. Unlike traditional acupuncture needles, this treatment uses painless laser light, making it completely non-invasive. Previous research has suggested auricular acupuncture may help prevent migraines, but evidence has been limited to smaller studies or secondary outcomes. This is the first placebo-controlled study specifically designed to test whether laser stimulation of ear points can effectively prevent episodic migraines. The results will help determine if this technique offers a safe, tolerable alternative for patients who cannot use standard preventive medications or want to avoid their side effects. If successful, this approach could provide an accessible option for migraine prevention without needles or medications. Patients interested in acupuncture or related therapies for migraine prevention should seek treatment from a qualified, licensed practitioner.

This double-blind, randomized, placebo-controlled study protocol examines auricular neuromodulation using low-level laser therapy (LLLT) for episodic migraine prophylaxis. The trial will enroll 106 adults experiencing 4-15 migraine days monthly, randomized to receive either active LLLT or sham treatment on selected auricular zones across three monthly sessions. The primary outcome measures change in migraine days during weeks 9-12 compared to a 4-week baseline period. While auricular acupuncture and auriculotherapy have shown promise for migraine prevention, evidence has been limited to secondary outcomes and case series. This represents the first placebo-controlled investigation of auricular neuromodulation specifically for episodic migraine prophylaxis using a non-invasive modality. The study addresses significant clinical needs given tolerability issues with first-line prophylactic medications and accessibility barriers to second-line treatments. Results will clarify whether non-invasive auricular stimulation provides clinically meaningful migraine reduction, potentially offering an evidence-based alternative for patients unable to tolerate pharmacological prophylaxis.