PTSD-FMS: Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
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.
Arms and Interventions
|Experimental: Treatment with reconsolidation therapy|
Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet
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.
Primary Outcome Measures
- 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)
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
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
Contacts and Locations
|1||Centre Hospitalier Henri Laborit||Poitiers||France|
Sponsors and Collaborators
- Centre Hospitalier Henri Laborit
- Principal Investigator: Yassir ELFAIROUQI, Dr, Centre Hospitalier Henri Laborit
Study Documents (Full-Text)None provided.