Clinical trial NCT04950426: Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
Official title: Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia Syndrome
Posttraumatic Stress Disorder
Lead sponsor: Centre Hospitalier Henri Laborit
Sponsor class: OTHER
First posted: 2021-07-06
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: 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 therapy.
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Henri Laborit
city: Thouars
country: France
facility: Centre Hospitalier Nord-Deux-Sèvres
Study officials:
affiliation: Centre Hospitalier Henri Laborit
name: Nematollah Jaafari, Professor
role: PRINCIPAL_INVESTIGATOR
References: