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

backgroundMigraine is a ubiquitous condition affecting more than 1 billion people worldwide. Prophylactic first-line treatments are hindered by unsatisfactory tolerability, and the accessibility of second-line treatment is hampered by cost or regulatory provisions. Auricular acupuncture and auriculotherapy appear to be effective as prophylactic treatments for migraines but are based only on secondary outcome measures or case series. Auricular neuromodulation is a recent technique that uses the stimulation zones of the auricle described by these two methods but with a different rationale. No study has compared the efficacy of auricular neuromodulation in the prophylactic treatment of episodic migraines with that of low-laser-level therapy (LLLT) with that of a placebo.

methodsThis double-blind randomized placebo-controlled two-arm study will include 106 adult patients suffering from episodic migraines, i.e., with the number of days of migraines ranging from 4-15 days per month. After randomization, patients benefit from three sessions of LLLT or sham LLLT on selected zones of the ear, one month apart. Efficiency will be assessed by measuring the number of days of migraine week 9-12 compared with the number of days of migraine 4 weeks before the first session. DISCUSSION: This study will assess whether three sessions of LLLT on selected zones on the ear, one month apart, increase the number of migraine-free days for patients suffering episodic migraine. This study is the first to demonstrate the efficacy of a noninvasive procedure in a placebo-controlled two-arm study.

trial registrationThis trial was registered in the US National Library of Medicine with the identifier NCT06623188. First registered: September 30, 2024. Last updated: October 2nd, 2024.