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

Last updated: August 19, 2024
Sponsor: Centre Hospitalier Henri Laborit
Overall Status: Active - Recruiting

Phase

2

Condition

Fibromyalgia

Post-traumatic Stress Disorders

Treatment

Propranolol

Clinical Study ID

NCT04950426
2021-000312-36
  • Ages > 18
  • All Genders

Study Summary

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 Criteria

Inclusion

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 toa traumatic event according to DSM-5 criteria, both unique or repeated andregardless of the date or location of the traumatic event.

  • Pain relief treatment and/or psychotropic treatment stabilized for a period greaterthan or equal to two months.

  • Signature of a consent form

  • Patient able to understand and read french

Exclusion

Exclusion Criteria:

  • Psychotic disorders

  • Unstable bipolar disorder

  • Patients with a systolic blood pressure < 100 mmHg or heart rate < 55 as establishedduring 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 symptomsand 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 Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Propranolol
Phase: 2
Study Start date:
August 13, 2021
Estimated Completion Date:
December 12, 2024

Connect with a study center

  • Centre Hospitalier Henri Laborit

    Poitiers,
    France

    Active - Recruiting

  • Centre Hospitalier Nord-Deux-Sèvres

    Thouars,
    France

    Active - Recruiting

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