A Feasibility Trial on Intranasal Evaporative Cooling for Acute Migraine in an At-Home Setting
Abstract
Background: A significant proportion of people with migraine do not achieve sufficient relief of their acute migraine symptoms with the currently available medications. A previous study showed that intranasal evaporative cooling reduced headache and migraine-associated symptoms when given in an outpatient clinic setting. This study aimed to evaluate the feasibility of self-administering the same intervention for acute migraine in an at-home setting. The findings of this study were intended to inform the design and implementation of a planned full-scale randomized controlled trial (RCT). Methods: We conducted a prospective single-group clinical feasibility trial in southern Sweden. Participants meeting the criteria for episodic migraine, with or without aura, were recruited through local advertisements. After a screening period, during which two migraine attacks were registered and evaluated under usual care, participants treated their next three migraine attacks at home with 10 minutes of intranasal cooling (RhinoChill®, BrainCool AB, Lund, Sweden). The primary outcome was a reduction in headache, nausea, photophobia, and phonophobia immediately after treatment. The secondary outcome was tolerability, and treatment effects within 24 hours. Results: Six out of 15 participants completed the study, using the cooling treatment for three consecutive migraine attacks. The main reasons for drop-out were pain/discomfort from treatment and lack of effect. A total of 23 treatments…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 15 participants or records.
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