Hyperbaric Oxygen vs. Standard Pharmaceutical Therapies for Fibromyalgia Syndrome - Prospective, Randomized Crossover Clinical Trial
概览
- 阶段
- 不适用
- 干预措施
- Crossover Hyperbaric oxygen therapy
- 疾病 / 适应症
- Fibromyalgia
- 发起方
- Assaf-Harofeh Medical Center
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Visual analogue Scale (VAS)
- 状态
- 已完成
- 最后更新
- 10天前
概览
简要总结
The investigators have previously studied the efficacy of hyperbaric oxygen therapy (HBOT) as a treatment for Fibromyalgia syndrome (FMS) in a prospective, active control, crossover clinical trial. The results demonstrated significant amelioration of all FMS symptoms, with significant improvement in life quality; furthermore, the investigators were able to demonstrate significant neuroplasticity on SPECT imaging, with a decrease of the hyperactivity in posterior regions and elevation of the reduced activity in frontal areas.
In the proposed study, the investigators intend to both repeat and expand our previous findings, treating FMS patients with HBOT while performing an extensive of evaluation both before and after treatment.
In the current study, the investigators plan to compare HBOT to current standard of care of FMS (pharmacological and non - pharmacological).
详细描述
The study will include 70 fibromyalgia patients in whom physical trauma, such mild traumatic brain injury (mTBI), could be considered as the trigger for FMS. Each participant will be examined at the time of recruitment and a diagnosis of FMS will be verified, based on the updated 2016 diagnostic criteria In the current study the investigators will recruit patients not currently being treated with medications specific for FMS, including anti-depression drugs, gabapentanoids and tricyclics, opiods and medical cannabis. Patients who are on such treatment will be required to discontinue treatment 2 weeks before recruitment. Patients will undergo randomization upon recruitment to one of the two study groups. One group will proceed to a course of HBOT treatment while the second group will commence with standard treatment for FMS, as outlined in the Israeli guidelines for the diagnosis and treatment of FMS \[41\]. These patients will be given detailed education regarding the nature of FMS as well as recommendations regarding non - pharmacological interventions recommended for FMS, including graded physical exercise, hydrotherapy, movement-meditative treatments (e.g. Tai Chi) and cognitive behavioral treatment (CBT). HBOT protocol: a total of 60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. 60 sessions will include exposure of 90 minutes to 100% at 2 Absolute atmospheres (ATA), with 5 minutes air breaks every 20 minutes. Pharmaceutical protocol: patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment. Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.
研究者
Shay Efrati
Prof.
Assaf-Harofeh Medical Center
入排标准
入选标准
- •FMS diagnosis, based on the updated 2016 diagnostic criteria
- •previous physical trauma (such as traumatic brain injury)
排除标准
- •the presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
- •active malignancy,
- •chronic ongoing infection
- •major psychiatric disorders (excluding anxiety)
- •Patients currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica) will also be excluded
- •previous HBOT for any other reason prior to their inclusion;
- •Chest pathology incompatible with pressure changes (including active asthma);
- •Inner ear disease
- •Claustrophobia;
- •Inability to perform awake brain MRI test;
研究组 & 干预措施
Pharmacotherapy
patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment. Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.
干预措施: Crossover Hyperbaric oxygen therapy
Pharmacotherapy
patients will be offered pharmacological treatment with one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg at bedtime while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 6 weeks patients will be evaluated and dose will be adjusted as necessary. Patients may also be switched from one medication to the other based according to clinical judgment. Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.
干预措施: Cymbalta / Lyrica treatment
Hyperbaric oxygen therapy
60 daily hyperbaric oxygen treatment sessions will be administrated 5 days per week. Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes Crossover: After 3 months of either pharmaceuitical or HBOT, once the 2nd evaluation is completed, all patients in both groups will be offered to switch to the alternative treatment group.
干预措施: Hyperbaric oxygen therapy (HBOT) treatment
结局指标
主要结局
Visual analogue Scale (VAS)
时间窗: at 6 months
The primary end point of the study will be the measurement of daily pain on a (0-10 scale) Visual analogue Scale
Visual analogue Scale (VAS)
时间窗: at 3 months
The primary end point of the study will be the measurement of daily pain on a (0-10) Visual analogue Scale
次要结局
- Wide Spread Pain Index(baseline, at 3 months, at 6 months)
- Global Pain Scale (GPS)(baseline, at 3 months, at 6 months)
- Patient global impression of change(baseline, at 3 months, at 6 months)
- EQ-5D(baseline, at 3 months, at 6 months)
- Cognitive function(baseline, at 3 months, at 6 months)
- Mean diffusivity(baseline, at 3 months, at 6 months)
- Brain function imaging(baseline, at 3 months, at 6 months)
- Brain network analysis(baseline, at 3 months, at 6 months)
- Heat/Cold Pain threshold evaluation(baseline, at 3 months, at 6 months)
- Conditioned pain modulation(baseline, at 3 months, at 6 months)
- Fibromyalgia Impact Questionnaire(baseline, at 3 months, at 6 months)
- Symptom Severity Scale(baseline, at 3 months, at 6 months)
- SF-36 questionnaire(baseline, at 3 months, at 6 months)
- Medical Outcome Sleep Scale(baseline, at 3 months, at 6 months)
- Beck Depression Inventory(baseline, at 3 months, at 6 months)
- Inflammatory cytokines(baseline, at 3 months, at 6 months)
- Cognitive function - CANTAB(baseline, at 3 months, at 6 months)
- Cerebral blood volume(baseline, at 3 months, at 6 months)
- Cerebral blood flow(baseline, at 3 months, at 6 months)
- Fractional anistropy(baseline, at 3 months, at 6 months)
- brain function imaging(baseline, at 3 months, at 6 months)
- Physical activity(baseline, at 3 months, at 6 months)
- Exercise capacity(baseline, at 3 months, at 6 months)
- CD4 number(baseline, at 3 months, at 6 months)
- CD8 number(baseline, at 3 months, at 6 months)
- CD4:CD8 ratio(baseline, at 3 months, at 6 months)
- CD4CD25 positive number(baseline, at 3 months, at 6 months)
- Microbiome(baseline, at 3 months, at 6 months)
- CD8+CD28null(baseline, at 3 months, at 6 months)
- Naïve B-Cells number(baseline, at 3 months, at 6 months)