Fibromyalgia SyndromePhase 2PTSD-FMSNCT04950426
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
A Phase 2 study testing Propranolol in people with Fibromyalgia Syndrome and Posttraumatic Stress Disorder, run by Centre Hospitalier Henri Laborit at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fibromyalgia Syndrome, Posttraumatic Stress Disorder
- What is being tested?
- Propranolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesFrance
- Study dates
- 13 Aug 2021to 13 Jan 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Henri Laborit
Poitiers
Centre Hospitalier Nord-Deux-Sèvres
Thouars
About this study
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.
- Being tested
- Propranolol
- Medical subject headings
- Fibromyalgia, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropranololDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with reconsolidation therapy | Experimental | Patient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet Receives: Drug: Propranolol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2021
- Study start13 Aug 2021
- Primary completion13 Jan 2025
- Study completion13 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fibromyalgia SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Henri Laborit
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nematollah Jaafari, Professor, Principal investigator, Centre Hospitalier Henri Laborit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950426
- Sponsor's protocol ID
- 2021-000312-36
- Acronym
- PTSD-FMS
- Status last verified
- Sep 2026
- First submitted
- 29 Jun 2021
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Harika Germaneau G, Rannou D, Charrier E, El Fairouqi Y, Brunet A, Doolub D, Langbour N, Raviart I, Wassouf I, Jaafari N. Impact of Post-Traumatic Stress Disorder Management Through Reconsolidation Therapy on Fibromyalgia Syndrome: A Pilot Study. Biomedicines. 2026 Jan 15;14(1):190. doi: 10.3390/biomedicines14010190.
PubMed 41595724
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
- ClinicalTrials.gov ID
- NCT04950426
- Acronym / sponsor ID
- PTSD-FMS / 2021-000312-36
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Centre Hospitalier Henri LaboritUniversity, hospital or other
- Study start
- 13 Aug 2021 (actual)
- Primary completion
- 13 Jan 2025 (actual)
- Study completion
- 13 Jan 2025 (actual)
- First posted
- 6 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with reconsolidation therapy | Experimental | Drug: PropranololPatient will take propranolol once a week during 6 weeks. The dosage of propranolol: 1 mg/kg propranolol form: tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PropranololOne 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. | Drug | Treatment with reconsolidation therapy |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Results publication: PubMed 41595724Harika Germaneau G, Rannou D, Charrier E, El Fairouqi Y, Brunet A, Doolub D, Langbour N, Raviart I, Wassouf I, Jaafari N. Impact of Post-Traumatic Stress Disorder Management Through Reconsolidation Therapy on Fibromyalgia Syndrome: A Pilot Study. Biomedicines. 2026 Jan 15;14(1):190. doi: 10.3390/biomedicines14010190.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nematollah Jaafari, Professor principal investigator
Centre Hospitalier Henri Laborit
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Propranolol in people with Fibromyalgia Syndrome and Posttraumatic Stress Disorder, run by Centre Hospitalier Henri Laborit at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04950426, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.