Abstract
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.
Highlights
Transcranial direct current stimulation is a non-invasive brain stimulation technique used in humans since the beginning of the twenty-first century
This study considered a lack of blinding if the upper bound of the confidence interval (CI) was below 0.5 [16,26]
The protocols for applying active and sham Transcranial direct current stimulation (tDCS) in this study have shown satisfactory blinding of the therapist and subjects with fibromyalgia who are treatment-naive for tDCS
Summary
Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation technique used in humans since the beginning of the twenty-first century. It consists of low-intensity galvanic currents applied on the cranium via a set of electrodes [1,2], which modulates the excitability of the brain cortex underneath them [2]. Creating a robust blinding method is one of the main demands for researchers to validate tDCS as an effective treatment in phase III of clinical trials [5]. Research protocols must include an assessment of the blinding methods using statistical models that determine their reliability and effectiveness
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