The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia

Gardoki-Souto, Itxaso; Martín de la Torre, Ona; Hogg, Bridget; Redolar-Ripoll, Diego; Martínez Sadurní, Laura; Fontana-McNally, Marta; Blanch, Josep M.; Lupo, Walter; Pérez Solá, Victor; Radua, Joaquim; Amann, Benedikt Lorenz; Valiente Gómez, Alicia; Moreno Alcázar, Ana

doi:http://dx.doi.org/10.1186/s13063-024-08708-3

The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia

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Gardoki-Souto I, Martín de la Torre O, Hogg B, Redolar-Ripoll D, Martínez Sadurní L, Fontana-McNally M, et al. The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgia. Trials. 2024 Dec 31;25(1):856. DOI: 10.1186/s13063-024-08708-3

Abstract

Background: Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. In recent years, different studies have observed a strong association between FM and psychological trauma. Therefore, a trauma-focused psychotherapy, such as Eye Movement Desensitization and Reprocessing (EMDR), combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation (MtCS), could be an innovative adjunctive treatment option. This double-blind randomized controlled trial (RCT) analyzes if EMDR therapy is effective in the reduction of pain symptoms in FM patients, and if its potential is boosted with the addition of MtCS. Methods: Ninety-six patients with FM and a history of traumatic events will be randomly allocated to the treatment as usual (TAU) condition, EMDR + active-MtCS condition, or EMDR + sham-MtCS condition. Therapists and patients will be kept blind to MtCS conditions, and raters will be kept blind to both EMDR and MtCS. All patients will be evaluated at baseline, post-treatment, and follow-up at 6 months after post-treatment. Evaluations will assess the following variables: sociodemographic data, pain, psychological trauma, sleep disturbance, anxiety and affective symptoms, wellbeing, self-care, emotional regulation, self-esteem, and cognitive functioning. Discussion: This study will provide evidence of whether EMDR therapy is effective in reducing pain symptoms in FM patients, and whether the effect of EMDR can be enhanced by MtCS. Trial registration number: This trial was registered at ClinicalTrials.gov on 2 August 2019, identifier: NCT04084795.