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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined HBOT/psychotherapy | Active Comparator | combined concurrent intervention of HBOT and creative art psychotherapy. |
|
| psychotherapy | Other | single intervention with creative art psychotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBOT | Biological | •HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain sensitivity | Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18) | 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 | 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. | Change after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia Impact on quality of life | Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shai a Efrati, MD | Asaf-Harofhe MC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf-Harofeh Medical Center | Ẕerifin | 70300 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30618929 | Derived | Hadanny A, Bechor Y, Catalogna M, Daphna-Tekoah S, Sigal T, Cohenpour M, Lev-Wiesel R, Efrati S. Hyperbaric Oxygen Therapy Can Induce Neuroplasticity and Significant Clinical Improvement in Patients Suffering From Fibromyalgia With a History of Childhood Sexual Abuse-Randomized Controlled Trial. Front Psychol. 2018 Dec 17;9:2495. doi: 10.3389/fpsyg.2018.02495. eCollection 2018. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| ID | Term |
|---|---|
| D004191 | Behavioral Disciplines and Activities |
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| Psychotherapy | Behavioral | creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions |
|
| Change after 3 months |
| Stress | Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51) | Change after 3 months t |
| Psychological symptoms | Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20) | Change after 3 months |
| Sensory symptoms | Sensory symptoms will be evaluated using the Sensory Profile questionnaires . | Change after 3 months |
| Somatoform Dissociation Questionnaire (SDQ-20) | Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20). | 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) | Change after 3 months |
| D009422 |
| Nervous System Diseases |