The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
Overview
- Phase
- Not Applicable
- Intervention
- HBOT
- Conditions
- Fibromyalgia
- Sponsor
- Assaf-Harofeh Medical Center
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Pain sensitivity
- Status
- Completed
- Last Updated
- 11 days ago
Overview
Brief Summary
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
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).
Investigators
Shay Efrati
Director of Sagol Center for Hyperbaric medicine and Research
Assaf-Harofeh Medical Center
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Combined HBOT/psychotherapy
combined concurrent intervention of HBOT and creative art psychotherapy.
Intervention: HBOT
Combined HBOT/psychotherapy
combined concurrent intervention of HBOT and creative art psychotherapy.
Intervention: Psychotherapy
psychotherapy
single intervention with creative art psychotherapy
Intervention: Psychotherapy
Outcomes
Primary Outcomes
Pain sensitivity
Time Frame: Change After 3 months
Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Brain microstructure
Time Frame: Change after 3 months
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
Brain Metabolism
Time Frame: Change after 3 months
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.
Secondary Outcomes
- Sensory symptoms(Change after 3 months)
- Psychological symptoms(Change after 3 months)
- Fibromyalgia Impact on quality of life(Change after 3 months)
- Short form health survey (sf-36)(Change after 3 months)
- Somatoform Dissociation Questionnaire (SDQ-20)(Change after 3 months)
- Childhood trauma psychological effects(Change after 3 months)
- Stress(Change after 3 months t)