Fibromyalgia Clinical Trial
Official title:
The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on 2 types of patients' population suffering from chronic pain syndrome (Fibromyalgia): patients with history of psychological trauma and patients with history of traumatic brain injury.
This study is a prospective clinical trial. After signing a written informed consent, all
patients will be invited to medical evaluation including pain sensitivity examination and a
series of questionnaires. In addition, all patients will have chest X-ray, cognitive
evaluation, brain MRI and brain Single-photon emission computed tomography (SPECT)
. A second brain MRI, brain SPECT, pain sensitivity evaluation and questionnaires will be
done after 3 months of treatment (60 sessions of HBOT). The HBOT procedure will be performed
at the Sagol center for hyperbaric medicine and research of Assaf Harofeh Medical Center,
Israel.
The following HBOT protocol will be applied for all patients: 12 weeks, 5 times per week,
daily administration of 100% O2 for 90 minutes at a pressure of 2 absolute atmospheres (ATA)
including 5 minutes air breaks every 30 minutes.
Patients with history of psychological trauma are also being treated with creative art
psychotherapy. These patients will be randomly assigned to one of the two groups: (1) single
intervention with creative art psychotherapy (psychotherapy group); (2) combined concurrent
intervention of HBOT and creative art psychotherapy. Groups 1 will serve as controls during
the first 3 months and then will be crossed to get HBOT. Before the cross to the HBOT they
will have 2nd full evaluation (questioners and brain imaging).
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