Augmentation of EMDR with multifocal transcranial current stimulation (MtCS) in the treatment of fibromyalgia : study protocol of a double-blind randomized controlled exploratory and pragmatic trial
Gardoki-Souto, Itxaso (Parc de Salut MAR de Barcelona)
Martín de la Torre, O. (Universitat Oberta de Catalunya. Estudis de Ciències de la Salut)
Hogg, Bridget (Parc de Salut MAR de Barcelona)
Redolar-Ripoll, D. (Universitat Oberta de Catalunya. Estudis de Ciències de la Salut)
Valiente-Gómez, Alicia (Parc de Salut MAR de Barcelona)
Martínez Sadurní, Laura (Parc de Salut MAR de Barcelona)
Blanch i Ribas, Josep Maria (Parc de Salut MAR de Barcelona)
Lupo, Walter (Parc de Salut MAR de Barcelona)
Pérez Solà, Víctor (Universitat Autònoma de Barcelona. Departament de Psiquiatria i de Medicina Legal)
Radua, Joaquim (Institut d'Investigacions Biomèdiques August Pi i Sunyer)
Amann, Benedikt L. (Parc de Salut MAR de Barcelona)
Moreno Alcázar, Ana (Institut Hospital del Mar d'Investigacions Mèdiques)

Data:	2021
Resum:	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. Forty-five patients with FM and a history of traumatic events will be randomly allocated to Waiting List, EMDR + active-MtCS, or EMDR + sham-MtCS. 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, and wellbeing. 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. ClinicalTrials. gov . Registered on 2 August 2019. The online version contains supplementary material available at 10. 1186/s13063-021-05042-w.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; altres ; Versió publicada
Matèria:	Fibromyalgia ; Eye movement desensitization and reprocessing ; Multifocal transcranial current stimulation ; Psychological trauma ; Pain ; Randomized controlled trial
Publicat a:	Trials, Vol. 22 (january 2021) , ISSN 1745-6215

DOI: 10.1186/s13063-021-05042-w
PMID: 33514408

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