Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorParc de Salut Mar

About this trial

Fibromyalgia (FM) is a generalized, widespread chronic pain disorder and has an estimated prevalence of 2%-4% in the general population. Current pharmacological and psychological interventions frequently produce limited benefits in FM patients. Due to FM's strong association with psychological trauma causing neurobiological alterations in stress response, a trauma-focused psychotherapy is an innovative alternative treatment option. Eye Movement Desensitization and Reprocessing (EMDR) has been recognized by the World Health Organization as a first-line therapeutic tool for post-traumatic stress disorder and first evidence suggests that it is also beneficial for patients with FM. Given the complex etiology of FM, a combination of psychotherapy with other treatment options can maximize a potential therapeutic success. A possible candidate herby is transcranial Direct Current Stimulation (tDCS), a non-invasive stimulation technique, which can modify neural activities related to pain and which has shown short-term positive effects on chronic pain and quality of life in FM patients. The patient sample will consist of 96 female patients meeting 2016 American College of Rheumatology criteria for FM based on a clinical interview. They will be randomized to 20 sessions of EMDR plus tDCS or EMDR plus sham-tDCS, or Treatment as Usual (TAU). Therapists, raters, and patients will be kept blind to tDCS treatment conditions. Evaluations will be at baseline, post treatment at 6 months, and follow-up at 12 months. Hypotheses are that EMDR improves pain intensity and clinical symptoms at short and long-term, and that tDCS enhances this effect, which will be superior to tDCS-sham.

Eligibility criteria

Qualifiers

Age between 18 and 70 years old

Mean pain score of at least 4 on the visual analog scale (VAS) in the two weeks preceding the clinical trial

Presence of one or more traumatic events causing current trauma-related symptoms

Current clinical symptoms of depression and/or anxiety

Disqualifiers

Comorbid autoimmune or chronic inflammatory disease

Neurological or serious medical diseases

Bipolar disorder, schizoaffective disorder and schizophrenia

Suicidal ideation

Trial design

Treatments tested in this trial

  • Eye Movement Desensitization and Reprocessing therapy
  • transcranial Direct Current Stimulation

Treatment groups

96 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Parc de Salut Mar

Lead sponsor

Universitat Oberta de Catalunya

Collaborator