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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• dc.contributor.author Gardoki-Souto, Itxaso
• dc.contributor.author Martín de la Torre, Ona
• dc.contributor.author Hogg, Bridget
• dc.contributor.author Redolar-Ripoll, Diego
• dc.contributor.author Martínez Sadurní, Laura
• dc.contributor.author Fontana-McNally, Marta
• dc.contributor.author Blanch, Josep M.
• dc.contributor.author Lupo, Walter
• dc.contributor.author Pérez Solá, Victor
• dc.contributor.author Radua, Joaquim
• dc.contributor.author Amann, Benedikt Lorenz
• dc.contributor.author Valiente Gómez, Alicia
• dc.contributor.author Moreno Alcázar, Ana
• dc.date.accessioned 2025-04-07T06:16:03Z
• dc.date.available 2025-04-07T06:16:03Z
• dc.date.issued 2024
• dc.description.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.
• dc.format.mimetype application/pdf
• dc.identifier.citation 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
• dc.identifier.doi http://dx.doi.org/10.1186/s13063-024-08708-3
• dc.identifier.issn 1745-6215
• dc.identifier.uri http://hdl.handle.net/10230/70100
• dc.language.iso eng
• dc.publisher BioMed Central
• dc.relation.ispartof Trials. 2024 Dec 31;25(1):856
• dc.rights © The Author(s) 2024. Open Access This article is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License, which permits any non-commercial use, sharing, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if you modified the licensed material. You do not have permission under this licence to share adapted material derived from this article or parts of it. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc-nd/4.0/.
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc-nd/4.0/
• dc.subject.keyword Eye Movement Desensitization and Reprocessing
• dc.subject.keyword Fibromyalgia
• dc.subject.keyword Multifocal transcranial current stimulation
• dc.subject.keyword Pain
• dc.subject.keyword Psychological trauma
• dc.subject.keyword Randomized controlled trial
• dc.title 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
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion