A Randomized, Controlled, Double-Blind Pilot Study of the Effects of Cranial Electrical Stimulation on Activity in Brain Pain Processing Regions in Individuals with Fibromyalgia

ObjectiveTo investigate the effects of microcurrent cranial electrical stimulation (CES) therapy on activity in pain processing brain regions.DesignA randomized, controlled, three-group, double-blind pilot study.ParticipantsPersons with physician-diagnosed fibromyalgia.InterventionActive CES device, sham device, and usual care alone.ResultsThose individuals using the active device had a greater decrease in average pain (P = .023) than individuals using the sham device or receiving usual care alone over time. Preliminary analyses of the functional magnetic resonance imaging data on a subset of six participants from each of the two device groups show that individuals using an active CES device had a decrease in activation in the pain processing regions of the brain compared to those using a sham device.ConclusionsThe observed decrease in activation in the pain processing regions may indicate a decrease in neural activity in these regions that may be related to decreased pain. This is the first randomized, controlled trial of CES in patients diagnosed with fibromyalgia to report functional magnetic resonance imaging data.