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OpenTrials
Completed

NCT Number: NCT04950426

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Hospitalier Henri Laborit, Poitiers, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

    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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Henri Laborit

Other

Registry information

Acronym: PTSD-FMS

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Jul 6, 2021
Registry last updated
Jun 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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