Abstract
BackgroundFibromyalgia (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.MethodsForty-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.DiscussionThis 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 registrationClinicalTrials.gov NCT04084795. Registered on 2 August 2019.
Highlights
Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population
The etiology of FM remains unknown, it is currently conceptualized as a disorder involving the sensitization of the central nervous system (CNS) and impairments in endogenous pain inhibitory mechanisms, with genetic, hormonal, and immunological factors playing a role [2]
Posttraumatic stress disorder (PTSD) is considered an important and frequently present comorbidity in patients suffering from FM [6, 7], it is often not given priority as a treatment objective
Summary
Fibromyalgia (FM) is a generalized, widespread chronic pain disorder affecting 2.7% of the general population. 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. Different risk factors associated with FM onset have been highlighted, including the presence of traumatic experiences such as sexual and physical abuse, chronic stress, and adverse lifetime events [3,4,5].
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