Abstract

PurposeFibromyalgia (FM) is a chronic pain syndrome with a strong impact on quality of life (QoL). Treatment of this condition remains a challenge, due to the scarce evidence for the effectiveness of the therapeutic approaches available. Current attention is focused on transcranial direct current stimulation (tDCS), which has yielded promising results for pain treatment. Rather than focusing only on pain relief, in this study, we aimed to determine how active or sham tDCS (over three cortical targets -the primary motor cortex, the dorsolateral prefrontal cortex and the operculo-insular cortex-) affect QoL in patients with FM.MethodsUsing a double-blind, placebo-controlled design, we applied fifteen tDCS sessions of 20’ to initial 130 participants (randomized to any of the four treatment groups). We evaluated the QoL (assessed by SF-36) and the symptoms’ impact (assessed by FIQ-R) in baseline, after treatment and at 6 months follow-up.ResultsAll groups were comparable as regards age, medication pattern and severity of symptoms before the treatment. We found that QoL and symptoms’ impact improved in all treatment groups (including the sham) and this improvement lasted for up to 6 months. However, we did not observe any group effect nor group*treatment interaction.ConclusionsAfter the intervention, we observed a non-specific effect that may be due to placebo, favoured by the expectations of tDCS efficacy and psychosocial variables inherent to the intervention (daily relationship with therapists and other patients in the clinic). Therefore, active tDCS is not superior to sham stimulation in improving QoL in FM.

Highlights

  • Fibromyalgia (FM) is a chronic pain syndrome that affects between 0.4 and 11% of the population (Wolfe et al, 2018); mainly women (80–90% of the diagnosis) [1–3]

  • They were comparable in age and medication patterns at baseline, as well as in severity of FM symptoms, quality of life and impact on daily life (FIQ-R) (Tables 1 and 2)

  • quality of life (QoL) is severely affected in patients with FM, most studies

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Summary

Introduction

Fibromyalgia (FM) is a chronic pain syndrome that affects between 0.4 and 11% of the population (Wolfe et al, 2018); mainly women (80–90% of the diagnosis) [1–3]. FM is characterized by widespread musculoskeletal pain, fatigue, sleep and mood disorders, and cognitive impairment [4]. Current clinical guidelines for the management of this syndrome suggest a multidisciplinary approach, including pharmacotherapy, therapeutic exercise, patient education and cognitive-behavioural therapy [12, 13]. These therapies usually only provide moderate relief of FM symptoms [13, 14]. The aetiology of FM is unknown, it is assumed

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