Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome (PTSD-FMS)

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.

Study Overview

• Status: Recruiting
• Conditions: Posttraumatic Stress Disorder; Fibromyalgia Syndrome
• Intervention / Treatment: Drug: Propranolol

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Nematollah JAAFARI, Professor; Phone Number: 0033 5 16 52 61 18; Email: namatollah.jaafari@ch-poitiers.fr

Study Locations

• France
  • Poitiers, France
    • Recruiting
    • Centre Hospitalier Henri Laborit
    • Contact: Yassir ELFAIROUQI
  • Thouars, France
    • Recruiting
    • Centre Hospitalier Nord-Deux-Sèvres
    • Contact: Issa Wassouf, Doctor; Email: wassouf.issa@chnds.fr
    • Principal Investigator: Issa Wassouf, Doctor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: Propranolol; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Henri Laborit
• Investigators: Principal Investigator: Nematollah Jaafari, Professor, Centre Hospitalier Henri Laborit

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2021
• Primary Completion (Estimated): August 12, 2024
• Study Completion (Estimated): August 12, 2024

Study Registration Dates

• First Submitted: June 29, 2021
• First Submitted That Met QC Criteria: June 29, 2021
• First Posted (Actual): July 6, 2021

Study Record Updates

• Last Update Posted (Actual): August 3, 2023
• Last Update Submitted That Met QC Criteria: August 2, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Disease; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Trauma and Stressor Related Disorders; Syndrome; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Fibromyalgia; Myofascial Pain Syndromes; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Vasodilator Agents; Propranolol
• Other Study ID Numbers: 2021-000312-36

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No