Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-25 @ 4:02 AM
NCT ID:
NCT04316702
Eligibility Criteria:
Inclusion Criteria:
* FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS).
* Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire.
* Ability to provide informed consent
* Age\>18
Exclusion Criteria:
* Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
* History of traumatic brain injury (TBI)
* Other FM etiologies
* Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)
* Contraindications to both Lyrica and Cymbalta
* Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)
* Previous suicidal attempt/s
* Does not take part in psychotherapy on a weekly basis (minimum)
* Previous HBOT for any other reason prior to their inclusion
* Chest pathology (including active asthma)
* Inner ear disease
* Claustrophobia
* Inability to perform awake brain MRI test
* Chronic renal failure (eGFR\< 60 ml/min)
* Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery
* Active Smoking
* Pregnancy or not committing to not getting pregnant during the study period
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT04316702
Study Brief:
Protocol Section:
NCT04316702