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

NCT ID: NCT04950426

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-13
• Study Completion Date: 2025-01-13

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.

Conditions

Fibromyalgia Syndrome; Posttraumatic Stress Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment with reconsolidation therapy

Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet

Group Type: EXPERIMENTAL

Propranolol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Henri Laborit

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nematollah Jaafari, Professor

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Henri Laborit

Locations

Centre Hospitalier Henri Laborit

Poitiers, , France

Centre Hospitalier Nord-Deux-Sèvres

Thouars, , France

Countries

France

Other Identifiers

2021-000312-36

Identifier Type: -

Identifier Source: org_study_id