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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04950426
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : January 19, 2023
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Henri Laborit

Study Description
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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 disease Intervention/treatment Phase
Fibromyalgia Syndrome Posttraumatic Stress Disorder Drug: Propranolol Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : August 13, 2021
Estimated Primary Completion Date : August 12, 2024
Estimated Study Completion Date : August 12, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/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
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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. [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04950426


Contacts
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Contact: Yassir ELFAIROUQI, Dr 0033 5 16 52 61 18 yassir.elfairouqi@ch-poitiers.fr

Locations
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France
Centre Hospitalier Henri Laborit Recruiting
Poitiers, France
Contact: Yassir ELFAIROUQI         
Sponsors and Collaborators
Centre Hospitalier Henri Laborit
Investigators
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Principal Investigator: Yassir ELFAIROUQI, Dr Centre Hospitalier Henri Laborit
More Information
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Responsible Party: Centre Hospitalier Henri Laborit
ClinicalTrials.gov Identifier: NCT04950426    
Other Study ID Numbers: 2021-000312-36
First Posted: July 6, 2021    Key Record Dates
Last Update Posted: January 19, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Syndrome
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Disease
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
 Neuromuscular Diseases
Nervous System Diseases
Propranolol
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents