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
| Autor: | Walter Lupo, Bridget Hogg, Alicia Valiente-Gómez, L Martínez Sadurní, J. Blanch, Ana Moreno-Alcázar, Benedikt L. Amann, Víctor Pérez, O Martín de la Torre, Itxaso Gardoki-Souto, Diego Redolar-Ripoll, Joaquim Radua |
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| Přispěvatelé: | Universitat Oberta de Catalunya (UOC), Institut de Neuropsiquiatria i Addiccions (INAD), Hospital del Mar Medical Research Institute (IMIM), Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red Salud Mental (CIBERSAM), Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Karolinska Institutet, King's College, Centre Forum Research Unit, Parc de Salut Mar |
| Rok vydání: | 2021 |
| Předmět: |
Fibromyalgia
Eye Movement Desensitization Reprocessing medicine.medical_treatment trauma psicológico Medicine (miscellaneous) Transcranial Direct Current Stimulation law.invention Study Protocol 0302 clinical medicine Randomized controlled trial estimulación de corriente transcraneal multifocal law Eye movement desensitization and reprocessing Psychological trauma Medicine desensibilització i reprocessament del moviment ocular dolor Pharmacology (medical) 030212 general & internal medicine education.field_of_study lcsh:R5-920 estimulació multifocal del corrent transcranial Treatment Outcome ensayo controlado aleatorio Anxiety Chronic Pain medicine.symptom lcsh:Medicine (General) medicine.medical_specialty assaig controlat aleatori Waiting Lists Multifocal transcranial current stimulation Population Pain 03 medical and health sciences Double-Blind Method Pragmatic Clinical Trials as Topic Humans education trauma psicològic Fibromiàlgia business.industry medicine.disease Fibromialgia Brain stimulation Adjunctive treatment Quality of Life Physical therapy business 030217 neurology & neurosurgery desensibilización y reprocesamiento del movimiento ocular |
| Zdroj: | Dipòsit Digital de Documents de la UAB Universitat Autònoma de Barcelona O2, repositorio institucional de la UOC Universitat Oberta de Catalunya (UOC) Trials, Vol 22, Iss 1, Pp 1-13 (2021) Trials |
| Popis: | 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 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. 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 ClinicalTrials.gov NCT04084795. Registered on 2 August 2019. |
| Databáze: | OpenAIRE |
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