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

Phase 2

Recruiting

• Conditions: Fibromyalgia Syndrome; Posttraumatic Stress Disorder
• Interventions: Drug: Propranolol

• Registration Number: NCT04950426
• Lead Sponsor: Centre Hospitalier Henri Laborit

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-06
• Study Start: 2021-08-13
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-12-12
• Study Completion: 2024-12-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment with reconsolidation therapy	Propranolol	Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (2)

Centre Hospitalier Henri Laborit; 🇫🇷 Poitiers, France

Centre Hospitalier Nord-Deux-Sèvres; 🇫🇷 Thouars, France