A New Approach to Assess Blinding for Transcranial Direct Current Stimulation Treatment in Patients with Fibromyalgia. A Randomized Clinical Trial.

Correct blinding is essential for preventing potential biases. The aim of this study was to assess the blinding of participants and a therapist following treatment with transcranial direct current stimulation in subjects with fibromyalgia using James' and Bang's blinding indexes. Eighty subjects were randomly allocated either active or sham stimulation groups in an intervention of five sessions lasting 20 min each. A questionnaire was delivered to both the therapist and patients after the last session to record their guess of which treatment had been applied. No differences between the groups were noted at baseline in terms of demographic or clinical data. James' BI was 0.83 (CI 95%: 0.76-0.90) for the patients and 0.55 (CI 95%: 0.45-0.64) for the therapist. Bang's BI for subjects was -0.08 (CI 95%: -0.24-0.09) and -0.8 (CI 95%: -0.26-0.1) for the active and sham transcranial direct current stimulation groups, respectively. Bang's BI for the therapist was 0.21 (CI 95%: -0.02-0.43) and 0.13 (CI 95%: -0.09-0.35) for the active and sham transcranial direct current stimulation groups, respectively. Protocols of active and sham transcranial direct current stimulation applied in this study have shown satisfactory blinding of the therapist and subjects with fibromyalgia.