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 Desensi...

Descripción completa

Detalles Bibliográficos
Autores: Gardoki-Souto, Itxaso, Martín de la Torre, Ona, Hogg, Bridget, Redolar-Ripoll, Diego Emilia, Martínez Sadurní, Laura, Fontana-McNally, Marta, Blanch, Josep M, Lupo, Walter, Pérez, V, Radua, Joaquim, Amann, Benedikt, Valiente-Gómez, Alicia, Moreno-Alcázar, Ana
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2024
País:España
Institución:Universitat Oberta de Catalunya (UOC)
Repositorio:O2, repositorio institucional de la UOC
OAI Identifier:oai:openaccess.uoc.edu:10609/153301
Acceso en línea:https://hdl.handle.net/10609/153301
http://doi.org/10.1186/s13063-024-08708-3
Access Level:acceso abierto
Palabra clave:fibromyalgia
eye movement desensitization and reprocessing
multifocal transcranial current stimulation
psychological trauma
pain
randomized controlled trial
id ES_f23a6c9788482f84bb9c90cdfe71bb21
oai_identifier_str oai:openaccess.uoc.edu:10609/153301
network_acronym_str ES
network_name_str España
repository_id_str
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, Diego EmiliaMartínez Sadurní, LauraFontana-McNally, MartaBlanch, Josep MLupo, WalterPérez, VRadua, JoaquimAmann, BenediktValiente-Gómez, AliciaMoreno-Alcázar, Anafibromyalgiaeye movement desensitization and reprocessingmultifocal transcranial current stimulationpsychological traumapainrandomized 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.BMC202520252024info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfhttps://hdl.handle.net/10609/153301http://doi.org/10.1186/s13063-024-08708-3reponame:O2, repositorio institucional de la UOCinstname:Universitat Oberta de Catalunya (UOC)InglésTrials, 2024, 25(1)Personal data of the participant will be numerically coded and kept in a database at the Centre Forum Research Unit. [...]info:eu-repo/grantAgreement/ISCIII/2024/PI23Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttps://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:openaccess.uoc.edu:10609/1533012026-05-28T12:42:01Z
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
fibromyalgia
eye movement desensitization and reprocessing
multifocal transcranial current stimulation
psychological trauma
pain
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 Emilia
Martínez Sadurní, Laura
Fontana-McNally, Marta
Blanch, Josep M
Lupo, Walter
Pérez, V
Radua, Joaquim
Amann, Benedikt
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 Emilia
Martínez Sadurní, Laura
Fontana-McNally, Marta
Blanch, Josep M
Lupo, Walter
Pérez, V
Radua, Joaquim
Amann, Benedikt
Valiente-Gómez, Alicia
Moreno-Alcázar, Ana
author_role author
author2 Martín de la Torre, Ona
Hogg, Bridget
Redolar-Ripoll, Diego Emilia
Martínez Sadurní, Laura
Fontana-McNally, Marta
Blanch, Josep M
Lupo, Walter
Pérez, V
Radua, Joaquim
Amann, Benedikt
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 fibromyalgia
eye movement desensitization and reprocessing
multifocal transcranial current stimulation
psychological trauma
pain
randomized controlled trial
topic fibromyalgia
eye movement desensitization and reprocessing
multifocal transcranial current stimulation
psychological trauma
pain
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 https://hdl.handle.net/10609/153301
http://doi.org/10.1186/s13063-024-08708-3
url https://hdl.handle.net/10609/153301
http://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, 25(1)
Personal data of the participant will be numerically coded and kept in a database at the Centre Forum Research Unit. [...]
info:eu-repo/grantAgreement/ISCIII/2024/PI23
dc.rights.none.fl_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
https://creativecommons.org/licenses/by-nc-nd/4.0/
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Attribution-NonCommercial-NoDerivatives 4.0 International
https://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv BMC
publisher.none.fl_str_mv BMC
dc.source.none.fl_str_mv reponame:O2, repositorio institucional de la UOC
instname:Universitat Oberta de Catalunya (UOC)
instname_str Universitat Oberta de Catalunya (UOC)
reponame_str O2, repositorio institucional de la UOC
collection O2, repositorio institucional de la UOC
repository.name.fl_str_mv
repository.mail.fl_str_mv
_version_ 1869424259796828160
score 15.81155

Similares en LA Referencia