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

Sponsor

Centre Hospitalier Henri Laborit (Other)

Overall Status

Recruiting

CT.gov ID

NCT04950426

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Fibromyalgia Syndrome Posttraumatic Stress Disorder	Drug: Propranolol	Phase 2

Study Design

Study Type:

Interventional

Anticipated 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 :

Aug 13, 2021

Anticipated Primary Completion Date :

Sep 13, 2022

Anticipated Study Completion Date :

Nov 13, 2022

Arms and Interventions

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.

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

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. [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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