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

• Status: Not yet recruiting
• Trial end date: 2021-09-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Henri Laborit
• Treatments: Propranolol

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

• 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