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

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 Desens...

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Autores: 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 Solà, Víctor, Radua, Joaquim, Amann, Benedikt Lorenz, Valiente Gómez, Alicia, Moreno Alcázar, Ana
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universitat Pompeu Fabra
Repositorio:Repositorio Digital de la UPF
OAI Identifier:oai:repositori.upf.edu:10230/70100
Acceso en línea:http://hdl.handle.net/10230/70100
http://dx.doi.org/10.1186/s13063-024-08708-3
Access Level:acceso abierto
Palabra clave:Eye Movement Desensitization and Reprocessing
Fibromyalgia
Multifocal transcranial current stimulation
Pain
Psychological trauma
Randomized controlled trial
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spelling The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgiaGardoki-Souto, ItxasoMartín de la Torre, OnaHogg, BridgetRedolar-Ripoll, DiegoMartínez Sadurní, LauraFontana-McNally, MartaBlanch, Josep M.Lupo, WalterPérez Solà, VíctorRadua, JoaquimAmann, Benedikt LorenzValiente Gómez, AliciaMoreno Alcázar, AnaEye Movement Desensitization and ReprocessingFibromyalgiaMultifocal transcranial current stimulationPainPsychological traumaRandomized controlled trialBackground: 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.BioMed Central202520252024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/70100http://dx.doi.org/10.1186/s13063-024-08708-3reponame:Repositorio Digital de la UPFinstname:Universitat Pompeu FabraInglésTrials. 2024 Dec 31;25(1):856© 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/.http://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repositori.upf.edu:10230/701002026-06-12T07:21:37Z
dc.title.none.fl_str_mv 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
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
spellingShingle 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
Eye Movement Desensitization and Reprocessing
Fibromyalgia
Multifocal transcranial current stimulation
Pain
Psychological trauma
Randomized controlled trial
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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.creator.none.fl_str_mv 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 Solà, Víctor
Radua, Joaquim
Amann, Benedikt Lorenz
Valiente Gómez, Alicia
Moreno Alcázar, Ana
author Gardoki-Souto, Itxaso
author_facet 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 Solà, Víctor
Radua, Joaquim
Amann, Benedikt Lorenz
Valiente Gómez, Alicia
Moreno Alcázar, Ana
author_role author
author2 Martín de la Torre, Ona
Hogg, Bridget
Redolar-Ripoll, Diego
Martínez Sadurní, Laura
Fontana-McNally, Marta
Blanch, Josep M.
Lupo, Walter
Pérez Solà, Víctor
Radua, Joaquim
Amann, Benedikt Lorenz
Valiente Gómez, Alicia
Moreno Alcázar, Ana
author2_role author
author
author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv Eye Movement Desensitization and Reprocessing
Fibromyalgia
Multifocal transcranial current stimulation
Pain
Psychological trauma
Randomized controlled trial
topic Eye Movement Desensitization and Reprocessing
Fibromyalgia
Multifocal transcranial current stimulation
Pain
Psychological trauma
Randomized controlled trial
description 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.
publishDate 2024
dc.date.none.fl_str_mv 2024
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10230/70100
http://dx.doi.org/10.1186/s13063-024-08708-3
url http://hdl.handle.net/10230/70100
http://dx.doi.org/10.1186/s13063-024-08708-3
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Trials. 2024 Dec 31;25(1):856
dc.rights.none.fl_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:Repositorio Digital de la UPF
instname:Universitat Pompeu Fabra
instname_str Universitat Pompeu Fabra
reponame_str Repositorio Digital de la UPF
collection Repositorio Digital de la UPF
repository.name.fl_str_mv
repository.mail.fl_str_mv
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