Status:
COMPLETED
Hyperbaric Oxygen Therapy Compared to Pharmaceutical in Fibromyalgia With Emotional Trauma
Lead Sponsor:
Assaf-Harofeh Medical Center
Collaborating Sponsors:
The Emili Sagol Creative Arts Therapies Research Center
Conditions:
Fibromyalgia
Emotional Trauma
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. Th...
Detailed Description
The study will include 60 fibromyalgia patients in whom emotional trauma, such as childhood abuse, could be considered as the trigger for FMS. Each participant will be examined at the time of recruitm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04316702
Start Date
March 1 2020
End Date
November 30 2023
Last Update
July 3 2024
Active Locations (1)
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1
hyperbaric center Asaf harofe medical center
Rishon LeZiyyon, Israel