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

NCT04950426 | Completed Phase 2

• 1 other identifier: 2021-000312-36
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Treatment with reconsolidation therapy

EXPERIMENTAL

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

Drug: Propranolol

Interventions

Propranolol 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.

Treatment with reconsolidation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Henri Laborit: lead

Study Sites (2)

Centre Hospitalier Henri Laborit

Poitiers, France

Location

Centre Hospitalier Nord-Deux-Sèvres

Thouars, France

Location

MeSH Terms

Conditions

Fibromyalgia; Stress Disorders, Post-Traumatic

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Nematollah Jaafari, Professor

  Centre Hospitalier Henri Laborit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 6, 2021
• Study Start: August 13, 2021
• Primary Completion: January 13, 2025
• Study Completion: January 13, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)