A Randomized Controlled Trial of a Transcutaneous Electrical Nerve Stimulation Device for the Acute Treatment of Migraine
Abstract
The goal of this clinical trial is to determine the efficacy of a new, improved neuromodulation device that can be worn on the head and neck to relieve migraine pain. To measure efficacy, investigators will compare how measured outcomes resulting from active stimulation with this device compare to those of sham treatment.
Conditions: Migraine, Migraine With or Without Aura, Migraine, Acute, Migraine Headache.
Primary outcome: Safety/Adverse Events; Pain Relief at 1 hour (Clinical Efficacy).
Enrollment: 160 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 160 participants or records.
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