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
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 Movemen...
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BMC
2024-12-01
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| Online Access: | https://doi.org/10.1186/s13063-024-08708-3 |
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| author | I. Gardoki-Souto O. Martín de la Torre B. Hogg D Redolar-Ripoll L. Martínez Sadurní M. Fontana-McNally J. M. Blanch W. Lupo V. Pérez J. Radua B. L. Amann A. Valiente-Gómez A. Moreno-Alcázar |
| author_facet | I. Gardoki-Souto O. Martín de la Torre B. Hogg D Redolar-Ripoll L. Martínez Sadurní M. Fontana-McNally J. M. Blanch W. Lupo V. Pérez J. Radua B. L. Amann A. Valiente-Gómez A. Moreno-Alcázar |
| author_sort | I. Gardoki-Souto |
| collection | DOAJ |
| 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. |
| format | Article |
| id | doaj-art-b1d1890bd0e84444890b4823866a8d00 |
| institution | Kabale University |
| issn | 1745-6215 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj-art-b1d1890bd0e84444890b4823866a8d002025-01-05T12:45:10ZengBMCTrials1745-62152024-12-0125111610.1186/s13063-024-08708-3The study protocol of a double-blind randomized controlled trial of EMDR and multifocal transcranial current stimulation (MtCS) as augmentation strategy in patients with fibromyalgiaI. Gardoki-Souto0O. Martín de la Torre1B. Hogg2D Redolar-Ripoll3L. Martínez Sadurní4M. Fontana-McNally5J. M. Blanch6W. Lupo7V. Pérez8J. Radua9B. L. Amann10A. Valiente-Gómez11A. Moreno-Alcázar12Centre Forum Research Unit Hospital del MarCognitive NeuroLab, Universitat Oberta de Catalunya (UOC)Centre Forum Research Unit Hospital del MarCognitive NeuroLab, Universitat Oberta de Catalunya (UOC)Institute of Mental Health Hospital del MarCentre Forum Research Unit Hospital del MarService of Rheumatology, Hospital del MarCentre Forum Research Unit Hospital del MarHospital del Mar Research InstituteInstitut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS)Centre Forum Research Unit Hospital del MarCentre Forum Research Unit Hospital del MarCentre Forum Research Unit Hospital del MarAbstract 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.https://doi.org/10.1186/s13063-024-08708-3FibromyalgiaEye Movement Desensitization and ReprocessingMultifocal transcranial current stimulationPsychological traumaPainRandomized controlled trial |
| spellingShingle | I. Gardoki-Souto O. Martín de la Torre B. Hogg D Redolar-Ripoll L. Martínez Sadurní M. Fontana-McNally J. M. Blanch W. Lupo V. Pérez J. Radua B. L. Amann A. Valiente-Gómez A. Moreno-Alcázar 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 Fibromyalgia Eye Movement Desensitization and Reprocessing Multifocal transcranial current stimulation Psychological trauma Pain Randomized controlled trial |
| 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 |
| 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_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_sort | study protocol of a double blind randomized controlled trial of emdr and multifocal transcranial current stimulation mtcs as augmentation strategy in patients with fibromyalgia |
| topic | Fibromyalgia Eye Movement Desensitization and Reprocessing Multifocal transcranial current stimulation Psychological trauma Pain Randomized controlled trial |
| url | https://doi.org/10.1186/s13063-024-08708-3 |
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