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临床试验/NCT02467218
NCT02467218已完成不适用

Hyperbaric Oxygen Therapy in Fibromyalgia : Effect on Global Function

University Health Network, Toronto2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Number of participants finishing the study protocol

研究概览

简要总结

Fibromyalgia (FM) is a chronic pain condition affecting several millions of Canadians. Although the etiology and pathophysiology are poorly understood, there is a well-recognized association between muscular pain in fibromyalgia and muscular hypoperfusion, hypoxia, abnormal muscle metabolism and oxidative stress. Currently there is no cure for FM. Pharmacological and non-pharmacological strategies are directed to control symptoms such as pain, fatigue, non-restorative sleep and depression.

Hyperbaric oxygen therapy (HBOT) is an intermittent inhalation of 100% oxygen in a hyperbaric chamber at a pressure higher than 1 absolute atmosphere. Physiological effect of HBOT is based on a dramatic increase in the amount of dissolved oxygen carried by the blood which enables oxygenation of ischemic areas with compromised circulation. It also activates oxidant-antioxidant system, stimulates angio- and neurogenesis, modulates inflammatory response, induces brain neuroplasticity and possesses analgesic effect.

While some interventions offer benefit for some patients, additional treatment alternatives are needed for patients with FM in whom currently available options are either ineffective or poorly tolerated. Given its physiological effect, HBOT could be considered as a potential therapy for treatment of underlying muscular hypoxia, optimizing oxidant- antioxidant system and controlling FM symptoms. The results from this study could therefore provide new information supporting the basic science underling the pathophysiology of this disease and stimulate novel therapies for patients suffering with FM.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Function Improvement Questionnaire (Revised) score ≥ 60 during the baseline assessment.

排除标准

  • •Women with positive pregnancy test or plans to become pregnant during the study period
  • •Claustrophobia
  • •Seizure disorder
  • •Active asthma
  • •Severe chronic obstructive pulmonary disease
  • •Previous thoracic surgery
  • •History of pneumothorax
  • •History of severe congestive heart failure with left ventricular ejection fraction < 30%
  • •Unstable angina
  • •Chronic sinusitis
  • •Chronic or acute otitis media or major ear drum trauma
  • •Current treatment with bleomycin, cisplatin, doxorubicin and disulfiram
  • •Participation in another investigative drug or device trial currently or within the last 30 days

研究组 & 干预措施

Delayed Hyperbaric Oxygen Treatment

Experimental

If the participant is assigned to the cross group, the participant will also receive a baseline assessment functional magnetic resonance imaging (fMRI). However, it will be followed-up in a controlled manner for 3 months. After 3 months, the participant will be receiving hyperbaric oxygen treatment identical to Group A and a follow-up fMRI will be performed after the last treatment.

干预措施: Hyperbaric Oxygen Treatment (Other)

Immediate Hyperbaric Oxygen Treatment

Experimental

If a participant is randomized to the group receiving the intervention, the participant will be receiving a baseline assessment functional magnetic resonance imaging (fMRI) and subsequently receiving hyperbaric oxygen treatment for 90 minutes, once daily, five times a week for 8 consecutive weeks (40 treatments with 100% oxygen at 2.0 ATA). A follow-up fMRI will be performed after the last day of treatment.

干预措施: Hyperbaric Oxygen Treatment (Other)

结局指标

主要结局

Number of participants finishing the study protocol

时间窗: 3 months post treatment

Feasibility as a number of participants finishing the study protocol

Number of participants experiencing intervention related adverse events

时间窗: Start of Treatment to post 3 months

Safety as a proportion of patients experiencing intervention-related adverse events during the study period

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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