HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma

Conditions
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Fibromyalgia, Chronic Pain Syndrome

Intervention / Treatment
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* Biological: HBOT
* Behavioral: Psychotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females Age over 18 Known fibromyalgia (chronic pain syndrome) for more than 1 year Exclusion Criteria: Any past hyperbaric treatment prior to inclusion Patients with chest x-ray pathology incompatible with hyperbaric environment Patients with middle ear problems Patients, who cannot pump, equals middle ear pressure, effectively Patients who suffer from claustrophobia Inability or Refusing to sign the Informed Consent Form

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combined HBOT/psychotherapy<br>combined concurrent intervention of HBOT and creative art psychotherapy. | Biological: HBOT<br>* •HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments<br>Behavioral: Psychotherapy<br>* creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions<br>|
| Other: psychotherapy<br>single intervention with creative art psychotherapy | Behavioral: Psychotherapy<br>* creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact on quality of life | Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100) | Change after 3 months | 
| Quality of Life | Quality of live will be evaluated by Quality of Life RAND hort form 36 questionnaire (SF36).(scale 0-100) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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more than 1 year