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

Primary Purpose

Fibromyalgia Syndrome, Posttraumatic Stress Disorder

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Propranolol
Sponsored by
Centre Hospitalier Henri Laborit
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Henri LaboritRecruiting
  • Centre Hospitalier Nord-Deux-SèvresRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with reconsolidation therapy

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
June 29, 2021
Last Updated
August 2, 2023
Sponsor
Centre Hospitalier Henri Laborit
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1. Study Identification

Unique Protocol Identification Number
NCT04950426
Brief Title
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
Acronym
PTSD-FMS
Official Title
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 13, 2021 (Actual)
Primary Completion Date
August 12, 2024 (Anticipated)
Study Completion Date
August 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Henri Laborit

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia Syndrome, Posttraumatic Stress Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with reconsolidation therapy
Arm Type
Experimental
Arm Description
Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet
Intervention Type
Drug
Intervention Name(s)
Propranolol
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nematollah JAAFARI, Professor
Phone
0033 5 16 52 61 18
Email
namatollah.jaafari@ch-poitiers.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nematollah Jaafari, Professor
Organizational Affiliation
Centre Hospitalier Henri Laborit
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Henri Laborit
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yassir ELFAIROUQI
Facility Name
Centre Hospitalier Nord-Deux-Sèvres
City
Thouars
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Issa Wassouf, Doctor
Email
wassouf.issa@chnds.fr
First Name & Middle Initial & Last Name & Degree
Issa Wassouf, Doctor

12. IPD Sharing Statement

Plan to Share IPD
No

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

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