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Impact of Post-Traumatic stress disorder treatment by reconsolidation therapy on fibromyalgia syndrome

NCT ID NCT04950426

NEW Sponsor: Centre Hospitalier Henri Laborit Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

17 people

The number who actually took part.

Started

Aug 2021

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

fibromyalgia post-traumatic stress disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibromyalgia syndrome Posttraumatic stress disorder

Contacts and locations

Locations

  • Centre Hospitalier Henri Laborit

    Poitiers, France

  • Centre Hospitalier Nord-Deux-Sèvres

    Thouars, France

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