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

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 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.

Resultados de una intervención psicoeducativa interdisciplinar con EMDR en pacientes con fibromialgia: experiencia de un centro privado

“…Al finalizar la segunda sesión, las puntuaciones promedio del FIQ habían disminuido un 12,9 %, 11,5 % en la escala de fatiga, un 28,6 % en la medida de ansiedad de Beck, y un 29,9 % en la medida de depresión de Beck; a los 3 meses los valores de caída llegaron respectivamente al 19,2 %, 26,7 %, 45,8 % y 31,6 % (47). Se halla actualmente en marcha un ensayo controlado doble ciego (ClinicalTrials.gov NCT04084795) patrocinado por el Parc de Salut del Mar (Barcelona, España), cuyo objetivo principal es analizar si el EMDR es eficaz en reducir (6 y 12 meses) los síntomas de dolor, ansiedad, depresión o trauma psicológico, en 45 pacientes con FM, y si este potencial puede aún ser mayor con la incorporación de estimulación cerebral no invasiva con corriente transcraneal multifocal (48).…”

Efficacy of Transcranial Direct Current Stimulation on Pain Level and Disability of Patients with Fibromyalgia: A Systematic Review of Randomized Controlled Trials with Parallel-Group Design

“…After removing duplicates and screening the abstracts based on the inclusion criteria, 26 RCTs remained for full-text assessment and data extraction. 12 studies were excluded with reasons (Figure 1) for using combined intervention with tDCS (n = 5) [20][21][22][23][24], not being an RCT (n = 4), crossover design (n = 2) [25,26], and one protocol study (n = 1) [27]. 14 studies were thus included in the final analysis [28][29][30][31][32][33][34][35][36][37][38][39][40][41].…”

The role of lifetime stressors in adult fibromyalgia: a response to Joan S. Crawford's letter to the editor

“…While evidence may be scarce, this does not mean that trauma-focused therapy would be ineffective in the treatment of a disorder as multifaceted as fibromyalgia. In fact, a protocol for the use of eye movement desensitization and reprocessing (EMDR), a type of trauma-focused therapy, was recently developed by Gardoki-Souto, de la Torre, Hogg, Redolar-Ripoll, Valiente-Gómez, Saduriní, … and Moreno-Alcázar (2021) after demonstrating in a double-blind randomised controlled trial that EMDR was effective in the reduction of pain symptoms in fibromyalgia patients when combined with a non-invasive brain stimulation technique, such as multifocal transcranial current stimulation.…”