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. 2024 Dec 31;25(1):856.
doi: 10.1186/s13063-024-08708-3.

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

I Gardoki-Souto  1 , O Martín de la Torre  2 , B Hogg  1 , D Redolar-Ripoll  2 , L Martínez Sadurní  3 , M Fontana-McNally  1 , J M Blanch  4 , W Lupo  1 , V Pérez  5   3   6   7 , J Radua  8   9   10 , B L Amann  11   12   13   14   15 , A Valiente-Gómez #  1   5   16   3   6 , A Moreno-Alcázar #  1   5   16
Affiliations

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

I Gardoki-Souto et al. Trials. .

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.

Keywords: Eye Movement Desensitization and Reprocessing; Fibromyalgia; Multifocal transcranial current stimulation; Pain; Psychological trauma; Randomized controlled trial.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study has been approved by the Ethics Committee of the Parc de Salut Mar (2019/8772/I) and re-approved with all changes for the new study by the same Ethics Committe in April 10th 2024. All participants will sign the informed consent prior to enrollment in the baseline visit. The informed consent will be available from the corresponding author upon request. Details of the design of the trial can be also gathered from Supplementary Material (Standard Protocol Items: Recommendations for Interventional Trials [SPIRIT] Checklist and Schedule of enrolment, interventions and assessments [SPIRIT] Flow diagram). The trial is registered at ClinicalTrials.gov, identifier: NCT04084795 (2nd of August of 2019). Consent for publication: Not applicable. Competing interests: BLA was the Research Committee Chair of EMDR Europe between 2017 and 2021 and has been invited as speaker to various national and international congresses of EMDR. AVG is member of the Research Committee of EMDR Europe since May 2023 until now. AMA is member of the Research Committee of the Spanish EMDR Organization since September 2023 until now. The other authors declare they have no competing interests.

Figures

Fig. 1
Fig. 1
SPIRIT checklist—Flow diagram: Schedule of enrollment, interventions and assessments. t1 = Baseline evaluation; 0 = randomization process; t2 = Post-treatment evaluation; t3 = Follow-up evaluation; t4 = Waitlist group participants receive treatment; VAS pain = Visual Analog Scale for pain; PCS = Pain Catastrophizing Scale; FIQ-R = Fibromyalgia Impact Questionnaire; BFI = Brief Fatigue Inventory; CTQ = Childhood Trauma Questionnaire; EGEP-5 = Evaluación General del Estrés Postraumático; TTE = Timeline of traumatic experiences; PCL-5 = Posttraumatic Stress Disorder Checklist, ITQ = The International Trauma Questionnaire; SUD = Subjective Units of Distress; CDS = Cambridge Depersonalization Scale; SDQ-20 = Somatoform Dissociation Questionnaire, MINI = MINI International Neuropsychiatric Scale; HADS = Hospital Anxiety and Depression Scale; AIS = Athens Insomnia Scale; SWLS = Satisfaction With Life Scale; ERSQ = Emotion Regulation Skills Questionnaire; RSE = Rosenberg Self-Esteem Scale; SCIP = Screen for cognitive impairment in psychiatry
Fig. 2
Fig. 2
Multifocal transcranial Current Stimulation (MtCS) montage
See this image and copyright information in PMC

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