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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments
creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions
Assaf-Harofeh Medical Center
Ẕerifin, Israel
Pain sensitivity
Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Time frame: Change After 3 months
Brain microstructure
MRI dynamic tensor imaging sequence will be performed (DTI). Fractional anisotropy (FA) values will be assessed at base line and at 3 months. The changes at 3 months from baseline will be compared
Time frame: Change after 3 months
Brain Metabolism
Brain metabolism will be assessed using SPECT at baseline, 3 monthsThe counts for each different Broadmann area values will be calculated. The changes at 3 months from baseline will be compared.
Time frame: Change after 3 months
Fibromyalgia Impact on quality of life
Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)
Time frame: Change after 3 months
Short form health survey (sf-36)
Quality of live will be evaluated by Quality of Life RAND Short form 36 questionnaire (SF36).(scale 0-100) higher score means better outcome.
Time frame: Change after 3 months
Stress
Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)
Time frame: Change after 3 months t
Psychological symptoms
Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)
Time frame: Change after 3 months
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Sensory symptoms
Sensory symptoms will be evaluated using the Sensory Profile questionnaires .
Time frame: Change after 3 months
Somatoform Dissociation Questionnaire (SDQ-20)
Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).
Time frame: Change after 3 months
Childhood trauma psychological effects
Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)
Time frame: Change after 3 months