HBOT Effect on Chronic Pain Syndrome With a History of Psychological Trauma
- Conditions
- FibromyalgiaChronic Pain Syndrome
- Interventions
- Behavioral: PsychotherapyBiological: HBOT
- Registration Number
- NCT03376269
- Lead Sponsor
- Assaf-Harofeh Medical Center
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- Females
- Age over 18
- Known fibromyalgia (chronic pain syndrome) for more than 1 year
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description psychotherapy Psychotherapy single intervention with creative art psychotherapy Combined HBOT/psychotherapy HBOT combined concurrent intervention of HBOT and creative art psychotherapy. Combined HBOT/psychotherapy Psychotherapy combined concurrent intervention of HBOT and creative art psychotherapy.
- Primary Outcome Measures
Name Time Method Pain sensitivity Change After 3 months Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Brain microstructure 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 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 Outcome Measures
Name Time Method Sensory symptoms Change after 3 months Sensory symptoms will be evaluated using the Sensory Profile questionnaires .
Psychological symptoms Change after 3 months Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20)
Fibromyalgia Impact on quality of life Change after 3 months Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100)
Somatoform Dissociation Questionnaire (SDQ-20) Change after 3 months Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20).
Childhood trauma psychological effects Change after 3 months Childhood trauma psychological effects will be evaluated using the Childhood Trauma Questionnaire (CTQ) questionnaires.(scale 0-125)
Stress Change after 3 months t Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51)
Short form health survey (sf-36) Change after 3 months Quality of live will be evaluated by Quality of Life RAND Short form 36 questionnaire (SF36).(scale 0-100) higher score means better outcome.
Trial Locations
- Locations (1)
Assaf-Harofeh Medical Center
🇮🇱Zerifin, Israel