Evaluating the Effects of Combined Transcutaneous Spinal Direct Current Stimulation and Exercise Therapy on Pain and Psychological Symptoms in Fibromyalgia Patients: A Prospective Randomized Study.

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.