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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia Syndrome, Posttraumatic Stress Disorder

Intervention / Treatment
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* Drug: Propranolol


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with reconsolidation therapy<br>Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet | Drug: Propranolol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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) | 3 months |