Fibromyalgia, Chronic Pain Syndrome
Conditions
Keywords
more than 1 year
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).
Interventions
BIOLOGICALHBOT
•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments
BEHAVIORALPsychotherapy
creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions
Sponsors
Assaf-Harofeh Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Psychological symptoms | Change after 3 months | Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20) |
| Sensory symptoms | Change after 3 months | Sensory symptoms will be evaluated using the Sensory Profile questionnaires . |
| Fibromyalgia Impact on quality of life | Change after 3 months | Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100) |
| 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) |
| Somatoform Dissociation Questionnaire (SDQ-20) | Change after 3 months | Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20). |
| 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. |
| Stress | Change after 3 months t | Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51) |
Countries
Israel
Outcome results
None listed