Transcranial direct current stimulation as a treatment for patients with fibromyalgia: a randomized controlled trial.

Previous studies suggest that transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) reduces chronic pain levels. In this randomized controlled trial, we investigated the effects of 5 consecutive 20-minute sessions of 2-mA anodal tDCS directed to the M1 in 48 patients (45 females) with fibromyalgia. Changes in pain, stress, daily functioning, psychiatric symptoms, and health-related quality of life were measured. Pain and stress were measured 30 days before treatment, at each treatment, and 30 days after treatment by using short message service on mobile phones. Patients were randomized to the active or sham tDCS group by receiving individual treatment codes associated either with the sham or active tDCS in the stimulator. Adverse effects were registered using a standardized form. A small but significant improvement in pain was observed under the active tDCS condition but not under the sham condition. Fibromyalgia-related daily functioning improved in the active tDCS group compared with the sham group. The stimulation was well tolerated by the patients, and no significant difference in the adverse effects between the groups was observed. The results suggest that tDCS has the potential to induce statistically significant pain relief in patients with fibromyalgia, with no serious adverse effects, but small effect sizes indicate that the results are unlikely to reflect clinically important changes.