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.

OBJECTIVE To investigate the effects of microcurrent cranial electrical stimulation (CES) therapy on activity in pain processing brain regions. DESIGN A randomized, controlled, three-group, double-blind pilot study. PARTICIPANTS Persons with physician-diagnosed fibromyalgia. INTERVENTION Active CES device, sham device, and usual care alone. RESULTS Those 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. CONCLUSIONS The 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.