Abstract
ObjectiveTo assess the safety and efficacy of external trigeminal nerve stimulation for acute pain relief during migraine attacks with or without aura via a sham-controlled trial.MethodsThis was a double-blind, randomized, sham-controlled study conducted across three headache centers in the United States. Adult patients who were experiencing an acute migraine attack with or without aura were recruited on site and randomly assigned 1:1 to receive either verum or sham external trigeminal nerve stimulation treatment (CEFALY Technology) for 1 hour. Pain intensity was scored using a visual analogue scale (0 = no pain to 10 = maximum pain). The primary outcome measure was the mean change in pain intensity at 1 hour compared to baseline.ResultsA total of 109 participants were screened between February 1, 2016 and March 31, 2017. Of these, 106 patients were randomized and included in the intention-to-treat analysis (verum: n = 52; sham: n = 54). The primary outcome measure was significantly more reduced in the verum group than in the sham group: −3.46 ± 2.32 versus −1.78 ± 1.89 (p < 0.0001), or −59% versus −30% (p < 0.0001). With regards to migraine subgroups, there was a significant difference in pain reduction between verum and sham for ‘migraine without aura’ attacks: mean visual analogue scale reduction at 1 hour was −3.3 ± 2.4 for the verum group versus −1.7 ± 1.9 for the sham group (p = 0.0006). For ‘migraine with aura’ attacks, pain reduction was numerically greater for verum versus sham, but did not reach significance: mean visual analogue scale reduction at 1 hour was −4.3 ± 1.8 for the verum group versus −2.6 ± 1.9 for the sham group (p = 0.060). No serious adverse events were reported and five minor adverse events occurred in the verum group.ConclusionOne-hour treatment with external trigeminal nerve stimulation resulted in significant headache pain relief compared to sham stimulation and was well tolerated, suggesting it may be a safe and effective acute treatment for migraine attacks.Study protocolClinicalTrials.gov Identifier: NCT02590939.
Highlights
Current available acute migraine treatments are mainly pharmacologic therapies (e.g. analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and ‘migraine-specific’ drugs such as ergots and triptans) [1,2,3] that have incomplete efficacy, as well as several side effects and contraindications; their excessive intake may lead to medication overuse headache and chronification of migraine [4,5]
The primary outcome was significantly decreased (p < 0.0001) in the verum and sham groups, but much more in the verum (À59%) than in the sham group (À30%); the effect size was large, with a Cohen’s d value of 0.88 (Figure 4)
Applying the aforementioned post hoc analysis of covariance (ANCOVA) sensitivity analysis, the treatment effect defined by the primary outcome measure remained highly significant (p < 0.0001)
Summary
Current available acute migraine treatments are mainly pharmacologic therapies (e.g. analgesics, non-steroidal anti-inflammatory drugs (NSAIDs), and ‘migraine-specific’ drugs such as ergots and triptans) [1,2,3] that have incomplete efficacy, as well as several side effects and contraindications; their excessive intake may lead to medication overuse headache and chronification of migraine [4,5]. An open-labeled pilot trial showed an average reduction of headache pain severity by 57.1% after a 1-hour e-TNS treatment, with 76.7% of patients reporting !50% pain relief [19] Based on these findings, we sought to further evaluate the safety and efficacy of e-TNS for acute pain relief during migraine attacks via the ACME study (ACute treatment of Migraine with External trigeminal nerve stimulation): a randomized, double-blind, shamcontrolled trial
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