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Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome

Recruiting
18 years of age
Both
Phase 2

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Overview

The aim of the study is to demonstrate a significant improvement in quality of life specific to patients with fibromyalgia syndrome in patients with fibromyalgia syndrome with comorbid posttraumatic stress disorder, treated with reconsolidation blockade.

Patients receive a treatment with propranolol associated with reconsolidation blockade of traumatic story once a week during 6 weeks, with evaluation at inclusion and at 3 months.

Eligibility

Inclusion Criteria:

  • Adult over 18 years old
  • Diagnosis of fibromyalgia syndrome according to ACR 2016 criteria
  • PCL-5 > 44 suggesting the presence of a comorbid post-traumatic stress disorder
  • Meet the DSM-5 criteria for post-traumatic stress disorder secondary to exposure to a traumatic event according to DSM-5 criteria, both unique or repeated and regardless of the date or location of the traumatic event.
  • Pain relief treatment and/or psychotropic treatment stabilized for a period greater than or equal to two months.
  • Signature of a consent form
  • Patient able to understand and read french

Exclusion Criteria:

  • Psychotic disorders
  • Unstable bipolar disorder
  • Patients with a systolic blood pressure < 100 mmHg or heart rate < 55 as established during the initial visit
  • Significant anormal ECG
  • Medical contraindication to taking propranolol
  • Adverse reactions or previous intolerances to a beta blocker
  • Current intake of another beta blocker which can not be stopped during the protocol, regardeless the galenic.
  • Current intake of a drug with potential contraindication with the propranolol, according to the summary of product characteristics of the propranolol.
  • Patient under legal protection, under guardianship or under curatorship
  • Patient having suffered a head trauma for less than a year or with clinical symptoms and neurological sequelae
  • Known severe suicide risk (MINI-S and medical exam)
  • Current opioid addiction or alcohol dependence
  • Patients treated for less than 2 months with antidepressants or painkillers
  • Patients unafiliated to a social health care
  • Woman who is pregnant or breast-feeding or whithout efficient contraception

Study details

Fibromyalgia Syndrome, Posttraumatic Stress Disorder

NCT04950426

Centre Hospitalier Henri Laborit

25 January 2024

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