A 1-hour treatment with external trigeminal nerve stimulation (e-TNS) was found to alleviate pain in individuals with migraine without aura, according to a study published in Cephalalgia.

In the first double-blind randomized sham-controlled trial evaluating the safety and efficacy of e-TNS for the acute treatment of migraine with and without aura, 99 patients were treated with verum (n=47) or sham (n=52) e-TNS for 1 hour. The trial named ACME (Acute treatment of Migraine with External trigeminal nerve stimulation; ClinicalTrials.gov identifier: NCT02590939), was conducted at 3 headache centers in the United States between February 2016 and March 2017. Patients were asked to rate pain intensity using an 11-point visual analogue scale at baseline, immediately after the 1-hour acute treatment phase, and at 2 hours and 24 hours post-treatment. Neurostimulation was administered via the e-TNS CEFALY device.

Mean change in pain score at 1 hour compared with baseline was decreased in patients treated with both verum and sham stimulation (P <.0001), but participants in the verum vs sham group reported greater levels of pain reduction (-59% vs -30%, respectively). The treatment efficacy remained significant in a post hoc analysis (<.0001). Mean pain score reduction was higher in the verum vs sham group at 2 hours (-50% vs -32%, respectively; P =.026) and at 24 hours (-57% vs -40%, respectively; P =.037) compared with baseline levels.

The researchers acknowledge small sample size and clinical setting for the trial as potential limitations.

”e-TNS is safe and well tolerated, offering migraine patients a non-invasive, acute treatment option that lacks the systemic side effects associated with conventional migraine medications,” concluded the study authors.

Related Articles

This study was supported by CEFALY Technology. Please refer to reference for a complete list of authors’ disclosures.

Reference

Chou DE, Shnayderman Yugrakh M, Winegarner D, Rowe V, Kuruvilla D, Schoenen J. Acute migraine therapy with external trigeminal neurostimulation (ACME): A randomized controlled trial [published online November 17, 2018]. Cephalalgia. doi:10.1177/0333102418811573

This article originally appeared on Clinical Pain Advisor