Fibromyalgia Syndrome, Posttraumatic Stress Disorder
Conditions
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.
Interventions
DRUGPropranolol
One administration of propranolol, once a week during six weeks. Reading by the participant of his/her traumatic story, 75 minutes (+/- 15 min) after propranolol intake.
Sponsors
Centre Hospitalier Henri Laborit
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 months | Modification in quality of life in patients with fibromyalgia syndrome measured by the Fibromyalgia Impact Measurement Questionnaire (FIQ). FIQ minimal value:0 (minimum impact) FIQ maximal value: 100 (maximal impact) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORNematollah Jaafari, Professor
Centre Hospitalier Henri Laborit
Outcome results
None listed