Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome (PTSD-FMS)

Centre Hospitalier Henri Laborit

Status and phase

Completed

Phase 2

Conditions

Posttraumatic Stress Disorder

Fibromyalgia Syndrome

Treatments

Drug: Propranolol

Study type

Interventional

Funder types

Other

Identifiers

NCT04950426

2021-000312-36

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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