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Updated: Sep 27, 2026

A Randomized, Sham-Controlled Trial of Cranial Electrical Stimulation for Fibromyalgia Pain and Physical Function, Using Brain Imaging Biomarkers
Published on: January 5, 2024
Evaluating the Effects of Combined Transcutaneous Spinal Direct Current Stimulation and Exercise Therapy on Pain and
Angelica De Sandi1, Daniele Saccenti2, Maurizio Vergari1
1Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.
Abstract:
Background: Chronic pain syndromes such as fibromyalgia have been associated with worsening health-related quality of life and increased incidence of comorbid psychiatric disorders, underscoring the need for targeted interventions. Transcutaneous spinal direct-current stimulation (tsDCS) and exercise therapy (ET) have been identified as promising non-pharmacological tools due to their capacity to inhibit pain transmission. However, empirical evidence regarding a combined efficacy remains limited. The aim of this work was, therefore, to test the effects of a multimodal treatment protocol on pain and psychological symptoms. Methods: Forty-five patients with fibromyalgia were recruited and randomly assigned to the tsDCS, ET, or combined tsDCS + ET group for a three-week period. Participants were assessed at baseline, one week after the start of treatment, at the end of the treatment (T2), and at 3-month follow-up (T3) using the Visual Analogue Scale (VAS), Brief Pain Inventory (BPI), Short-Form Health Survey (SF-12), and Hospital Anxiety and Depression Scale (HADS). Results: Analysis of variance applied to linear mixed-effect models showed significant group-by-time interaction effects on both HADS domains (anxiety: p = 0.004; depression: p = 0.028). Post hoc pairwise comparisons highlighted that tsDCS + ET decreased subjects' anxiety at both T2 (p = 0.002) and T3 (p < 0.001) compared to baseline. Yet, significant comparisons were not found for depression. No significant interactions were detected on VAS, BPI, and SF-12 scores. Conclusions: Although between-group differences were not observed, the integration of neuromodulation with physical activity resulted in a significant improvement in patients' anxiety-related symptoms severity, suggesting a potential added benefit.
