Overview

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

Status:
Not yet recruiting
Trial end date:
2021-09-29
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Henri Laborit
Treatments:
Propranolol
Criteria
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