Post-Traumatic Stress Disorder and fibromyalgia syndrome MedDRA version: 21.1 Level: LLT Classification code 10057246 Term: Prolonged post-traumatic stress disorder System Organ Class: 100000004873 MedDRA version: 20.0 Level: LLT Classification code 10016631 Term: Fibromyalgia syndrome System Organ Class: 100000004859
Conditions
Interventions
Trade Name: Avlocardyl
Product Name: Avlocardyl
Pharmaceutical Form: Tablet
Sponsors
Henri Laborit Hospital
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
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 |
|---|---|
| Main Objective: 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.;Secondary Objective: Secondary objectives are to show after treatment by reconsolidation therapy in patients with fibromyalgia syndrom and comorbid post-traumatic stress disorder a : 1-Significant decrease of post-traumatic stress disorder symptoms. 2-Significant decrease in fibromyalgia pain 3-Decrease in expanse of painful areas 4-Detection of associated psychiatric comorbidities 5-Decrease in the severity of depressive symptoms 6-Improvement of self esteem 7-Improvement of psychological and somatic quality of live 8-Improvement of the patient’s overall clinical condition ;Primary end point(s): Modification in quality of life in patients with fibromyalgia syndrome measured by the Fibromyalgia Impact Measurement Questionnaire (FIQ).;Timepoint(s) of evaluation of this end point: At day 0 (pre-treatment) and at 3 months (post-treatment). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1- Use of the french version of the Posttraumatic Stress Disorder Checklist–5 (PCL-5) for quantification of the PTSD severity. Difference between score at J0 and at M3 will be calculated and a decrease of 30% will be considered significant. 2- Evolution of the average of pain score over the last 7 days on a visual analog scale. 3- Evolution of the extent of pain mapping on a body diagram. 4- Detection of associated psychiatric comorbidities by the l’International Neuropsychiatric Interview (MINI). 5- Evolution of the severity of associated depressive symptomatology evaluated by the Montgomery and Asberg Depression Rating Scale (MADRS) and by the Beck Depression Inventory (BDI) questionnaire. 6- Evolution of self esteem measured by the Rosenberg scale. 7- Evolution of psychology and somatic quality of life evaluated by the SF-36 scale. 8- Modification of the patient’s global clinical condition severity appreciated by the Clinical Global Impression (CGI) scale. ;Timepoint(s) of evaluation of this end point: At day 0 (pre-treatment) and at 3 months (post-treatment). | — |
Countries
France
Contacts
Public ContactHenri Laborit Hospital
Henri Laborit Hospital
Outcome results
None listed