RecruitingNot ApplicableNCT04084795

Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia

Augmentation of EMDR With Transcranial Direct Current Stimulation (tDCS) in the Treatment of Fibromyalgia: a Double-blind Randomized Controlled Trial


Sponsor

Parc de Salut Mar

Enrollment

96 participants

Start Date

Jan 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • 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
  • weeks of stable medication

Exclusion Criteria10

  • Comorbid autoimmune or chronic inflammatory disease
  • Neurological or serious medical diseases
  • Bipolar disorder, schizoaffective disorder and schizophrenia
  • Suicidal ideation
  • Previous EMDR therapy in the past two years
  • Substance abuse/dependency within 1 month prior to participation (except for nicotine abuse/dependency),
  • Pending FM-related litigation or disability
  • Metallic implants in the head
  • Positive test for pregnancy
  • Skin sensitivity diseases (psoriasis, eczema, dermatitis, etc.)

Interventions

BEHAVIORALEye Movement Desensitization and Reprocessing therapy

EMDR is a psychotherapeutic approach using a standardized 8-phase protocol to alleviate the distress associated with traumatic memories, facilitating the access to and processing of traumatic memories. Patients will receive 20 individual EMDR sessions of 60 minutes each using the standard protocol, as well as a specific pain protocol and the fibromyalgia protocol. EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements). The current standard protocol includes eight phases: Patient history. Patient preparation. Patient assessment. Memory desensitization. Installing the positive cognition. Body scan. Closure. Reevaluation.

OTHERtranscranial Direct Current Stimulation

tDCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. F3 anodal; Fp1, F7, Fc5, AF3, Fc1, Fz, return montage will be used with the anode over the left DLPFC. Half of the patients will receive active stimulation and the other half sham stimulation. Active stimulation will consist of 2mA tDCS for 20 minutes applied immediately before EMDR sessions. The same protocol and montage will be used for sham stimulation.


Locations(1)

Centre Forum (Parc de Salut Mar)

Barcelona, Catalonia, Spain

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NCT04084795


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