Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome (PTSD-FMS)
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|ClinicalTrials.gov Identifier: NCT04950426|
Recruitment Status : Recruiting
First Posted : July 6, 2021
Last Update Posted : January 19, 2023
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
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.
- 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)
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
|Contact: Yassir ELFAIROUQI, Dr||0033 5 16 52 61 email@example.com|
|Centre Hospitalier Henri Laborit||Recruiting|
|Contact: Yassir ELFAIROUQI|
|Principal Investigator:||Yassir ELFAIROUQI, Dr||Centre Hospitalier Henri Laborit|