Fibromyalgia Clinical Trial
— HBOTCSAOfficial title:
The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
Verified date | December 2017 |
Source | Assaf-Harofeh Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | November 2017 |
Est. primary completion date | June 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Israel | Assaf-Harofeh Medical Center | Zerifin |
Lead Sponsor | Collaborator |
---|---|
Assaf-Harofeh Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain sensitivity | Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18) | Change After 3 months | |
Primary | 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 | |
Primary | 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 | Fibromyalgia Impact on quality of life | Evaluated by Fibromyalgia Impact Questionnaire (FIQ).(scale 0-100) | Change after 3 months | |
Secondary | 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 | |
Secondary | Stress | Stress will be evaluated using the Perceived stress scale (PSS) questionnaire.(scale 0-51) | Change after 3 months t | |
Secondary | Psychological symptoms | Psychological symptoms will be evaluated using Brief Symptom Inventory(BSI) questionnaire.(scale 0-20) | Change after 3 months | |
Secondary | Sensory symptoms | Sensory symptoms will be evaluated using the Sensory Profile questionnaires . | Change after 3 months | |
Secondary | Somatoform Dissociation Questionnaire (SDQ-20) | Dissociation symptoms will be evaluated using the Somatoform Dissociation Questionnaire (SDQ-20). | Change after 3 months | |
Secondary | 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 |
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