The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia) With a History of Psychological Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pain sensitivity
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age over 18
- •Known fibromyalgia (chronic pain syndrome) for more than 1 year
排除标准
- •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
研究组 & 干预措施
Combined HBOT/psychotherapy
combined concurrent intervention of HBOT and creative art psychotherapy.
干预措施: HBOT (Biological)
Combined HBOT/psychotherapy
combined concurrent intervention of HBOT and creative art psychotherapy.
干预措施: Psychotherapy (Behavioral)
psychotherapy
single intervention with creative art psychotherapy
干预措施: Psychotherapy (Behavioral)
结局指标
主要结局
Pain sensitivity
时间窗: Change After 3 months
Using (AlogMed) dolorimeter, pain sensitivity will be examined in 18 trigger points (scale0-18)
Brain microstructure
时间窗: 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
时间窗: 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.
次要结局
- 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)
研究者
Shay Efrati
Director of Sagol Center for Hyperbaric medicine and Research
Assaf-Harofeh Medical Center