Treatment for fibromyalgia and PTSD using reconsolidation therapy
Impact of Post-Traumatic Stress Disorder Treatment by Reconsolidation Therapy on Fibromyalgia Syndrome
PHASE2 · Centre Hospitalier Henri Laborit · NCT04950426
This study is testing if a combination of a heart medication and a special therapy can help people with fibromyalgia and PTSD feel better over six weeks.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Henri Laborit (other) |
| Locations | 2 sites (Poitiers and 1 other locations) |
| Trial ID | NCT04950426 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the quality of life for patients suffering from fibromyalgia syndrome who also have post-traumatic stress disorder (PTSD). Participants will receive propranolol in conjunction with a reconsolidation blockade of their traumatic experiences once a week for six weeks. Evaluations will be conducted at the start of the study and again after three months to assess the effectiveness of the treatment. The focus is on patients who meet specific diagnostic criteria for both conditions.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with fibromyalgia and a diagnosis of comorbid PTSD.
Not a fit: Patients with psychotic disorders, unstable bipolar disorder, or significant cardiovascular issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the quality of life for patients with fibromyalgia and PTSD.
How similar studies have performed: While the approach of using reconsolidation therapy is innovative, similar studies have shown promise in treating PTSD, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Poitiers and 1 other locations
- Centre Hospitalier Henri Laborit — Poitiers, France (RECRUITING)
- Centre Hospitalier Nord-Deux-Sèvres — Thouars, France (RECRUITING)
Study contacts
- Principal investigator: Nematollah Jaafari, Professor — Centre Hospitalier Henri Laborit
- Study coordinator: Nematollah JAAFARI, Professor
- Email: namatollah.jaafari@ch-poitiers.fr
- Phone: 0033 5 16 52 61 18
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fibromyalgia Syndrome, Posttraumatic Stress Disorder