Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome - Prospective, Randomized Crossover Clinical Trial

0058-17-ASF

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. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas. In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment. In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).

2017-03-01

2022-06-01

2022-06-01

Completed

76

Inclusion Criteria: * FMS diagnosis, based on the updated 2016 diagnostic criteria * previous physical trauma (such as traumatic brain injury) Exclusion Criteria: * the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders. * active malignancy, * chronic ongoing infection * major psychiatric disorders (excluding anxiety) * Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded * previous HBOT for any other reason prior to their inclusion; * Chest pathology incompatible with pressure changes (including active asthma); * Inner ear disease * Claustrophobia; * Inability to perform awake brain MRI test; * Previous neurologic conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); * Brain tumors; * Skull base fractures; * s/p neurosurgery that included: ventricular drainage, subdural hematomas drainage, epidural hematomas drainage, intracerebral hemorrhage evacuation. Depressed fracture surgery, (Patients suffering from Encephalomalacia per MRI imaging will not be excluded). * Inability to provide informed consent

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'randomized controlled trial using conventional pharmacotherapy treatment compared to hyperbaric oxygen therapy', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "randomization by computer, the patient and her primary care physician will know the treatment received. Any side effects during therapy will be reported to the care providers and nurses and physicians unrelated to the study. Investigators and outcome assessors will not know the patient's arm.", 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 76, 'type': 'ACTUAL'}}

2024-07-03