Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
Overview
- Phase
- Phase 2
- Intervention
- Propranolol
- Conditions
- Fibromyalgia Syndrome
- Sponsor
- Centre Hospitalier Henri Laborit
- Enrollment
- 17
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
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
Arms & Interventions
Treatment with reconsolidation therapy
Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet
Intervention: Propranolol
Outcomes
Primary Outcomes
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.
Time Frame: 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)