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

Sponsor
Centre Hospitalier Henri Laborit (Other)
Overall Status
Recruiting
CT.gov ID
NCT04950426
Collaborator
(none)
25
Enrollment
1
Location
1
Arm
15
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
25 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
Actual Study Start Date :
Aug 13, 2021
Anticipated Primary Completion Date :
Sep 13, 2022
Anticipated Study Completion Date :
Nov 13, 2022

Arms and Interventions

ArmIntervention/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.

Outcome Measures

Primary Outcome Measures

  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. [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Centre Hospitalier Henri LaboritPoitiersFrance

Sponsors and Collaborators

  • Centre Hospitalier Henri Laborit

Investigators

  • Principal Investigator: Yassir ELFAIROUQI, Dr, Centre Hospitalier Henri Laborit

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Henri Laborit
ClinicalTrials.gov Identifier:
NCT04950426
Other Study ID Numbers:
  • 2021-000312-36
First Posted:
Jul 6, 2021
Last Update Posted:
Jan 5, 2022
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022