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

Posttraumatic Stress Disorder Clinical Trial

— PTSD-FMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04950426
• Other study ID #: 2021-000312-36
• Status: Recruiting
• Phase: Phase 2
• Start date: August 13, 2021
• Est. completion date: August 12, 2024

Study information

• Verified date: August 2023
• Source: Centre Hospitalier Henri Laborit
• Contact: Nematollah JAAFARI, Professor
• Phone: 0033 5 16 52 61 18
• Email: namatollah.jaafari[@]ch-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 12, 2024
• Est. primary completion date: August 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Fibromyalgia Syndrome
• Myofascial Pain Syndromes
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
France	Centre Hospitalier Henri Laborit	Poitiers
France	Centre Hospitalier Nord-Deux-Sèvres	Thouars

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Henri Laborit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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