Hyperbaric Oxygen Therapy vs. Pharmaceutical Therapy in Patients Suffering From Fibromyalgia That Was Induced by Emotional Trauma: Prospective, Randomized, Two Active Arms Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Fibromyalgia Impact Questionnaire (FIQ) questionnaire
研究概览
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 this study, the investigators intend to both repeat and expand the investigator's previous findings, treating FMS patients with history of emotional trauma 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 60 fibromyalgia patients in whom emotional trauma, such as childhood abuse, 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 the target medications (Lyrica or Cymbalta).
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 .
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 twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
randomization by computer, the patient and her primary care physician will know the treatment received. Any side effects during therapy will be reported to the care providers and nurses and physicians unrelated to the study. Investigators and outcome assessors will not know the patient's arm.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •FM diagnosis based on the widespread pain index (WPI) and the Symptom Severity Score (SSS).
- •Score at the trauma questionnaire indicating low, moderate or severe trauma in one of the criteria specified in the questionnaire.
- •Ability to provide informed consent
排除标准
- •Presence of systemic inflammatory disorders including inflammatory rheumatological and autoimmune disorders.
- •History of traumatic brain injury (TBI)
- •Other FM etiologies
- •Currently or previously treated with Duloxetine (Cymbalta) or Pregabalin (Lyrica)
- •Contraindications to both Lyrica and Cymbalta
- •Major psychiatric disorder (such as major depression, schizophrenia, bi-polar disorder)
- •Previous suicidal attempt/s
- •Does not take part in psychotherapy on a weekly basis (minimum)
- •Previous HBOT for any other reason prior to their inclusion
- •Chest pathology (including active asthma)
- •Inner ear disease
- •Claustrophobia
- •Inability to perform awake brain MRI test
- •Chronic renal failure (eGFR< 60 ml/min)
- •Previous neurological conditions (eg. Epilepsy, neuromuscular diseases, metabolic diseases, etc.); Brain tumors; Skull base fractures; Active malignancy; s/p neurosurgery
- •Active Smoking
- •Pregnancy or not committing to not getting pregnant during the study period
研究组 & 干预措施
Hyperbaric Oxygen
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
干预措施: Hyperbaric oxygen therapy (HBOT) treatment (Device)
Pharmacotherapy
Two medications currently licensed for the treatment of FM in Israel, i.e. Cymbalta and Lyrica. Treatment with Lyrica will start at a dose of 75 mg twice a day, at morning and at bedtime, while treatment with Cymbalta will start at a dose of 30 mg a day (in the morning). After a period of 2 weeks, patients will be evaluated and dose will be adjusted as necessary and tolerated, up to the maximum dosage recommended for FM. Patients may also be switched from one medication to the other according to clinical judgment of the physician.
干预措施: Cymbalta / Lyrica - Drug treatment (Drug)
结局指标
主要结局
Fibromyalgia Impact Questionnaire (FIQ) questionnaire
时间窗: at 6 months
Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of follow up period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome
Fibromyalgia Impact Questionnaire (FIQ) questionnaire
时间窗: at 3 months
Fibromyalgia Impact Questionnaire (FIQ) questionnaire score at the end of treatment period (HBOT/pharmaceutical). Score range 0-100, higher score means worse outcome
次要结局
- conditioned pain modulation using Heat test-stimulus (HTS)(at baseline, 3 months)
- Brain functionality(at baseline, 3 months)
- NeuroTrax(at baseline, 3 months)
- CANTAB Cambridge Neuropsychological Test Automated Battery(at baseline, 3 months)
- Heat pain threshold(at baseline, 3 months)
- Cerebral blood volume(at baseline, 3 months)
- Brain function imaging(at baseline, 3 months)
- Inflammatory cytokines(at baseline, 3 months)
- Cerebral blood Flow(at baseline, 3 months)
- Mean diffusivity(at baseline, 3 months)
- Metabolic Brain function imaging(at baseline, 3 months)
- Physical activity(at baseline, 3 months)
- Fractional anisotropy(at baseline, 3 months)
- Endocrine system(at baseline, 3 months)
- Medical somatic dissociation questionnaire (MSDQ)(at baseline, 3 months, 6 months)
- Beck depression inventory (BDI)(at baseline, 3 months, 6 months)
- Short form health survey (sf-36)(at baseline, 3 months, 6 months)
- Recovery promoting relationships scale (RPRS)(at baseline, 3 months, 6 months)
- draw a person (DAP) assignment(at baseline, 3 months, 6 months)
- patient's global impression of change PGIC questionnaire(at 3 months, at 6 months)
- the brief symptom inventory (BSI-18)(at baseline, 3 months, 6 months)
- Widespread pain index questionnaire(at baseline, 3 months, 6 months)
- Symptoms severity scale questionnaire(at baseline, 3 months, 6 months)
- Post traumatic stress disorder (PTSD) symptoms scale (PSS) questionnaire(at baseline, 3 months, 6 months)
研究者
Shay Efrati
Head of Sagol center for hyperbaric medicine and research
Assaf-Harofeh Medical Center