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临床试验/NCT01827683
NCT01827683已完成不适用

The Effect of Hyperbaric Oxygen on Patients Suffering From Chronic Pain Syndrome (Fibromyalgia)

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2010年5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
60
试验地点
1
主要终点
Pain evaluation

研究概览

简要总结

The aim of the study is to evaluate the effect of hyperbaric oxygen therapy (HBOT) on patients suffering from chronic pain syndrome (Fibromyalgia).

详细描述

The study is a prospective, randomized, cross-over trial. Patients will be randomized into two groups (test and control) to receive the HBOT at the beginning of the trial or 2 months afterwards. The control group will receive its treatment after the elapsed two months.

This study will be a prospective, randomized cross over study. After signing a written informed consent, all patients will be invited to a 2 hour examination, including pain sensitivity examination and a series of questionnaires. In addition, prior to the beginning of the treatment all patients will have chest X-ray, neurological examination, cognitive evaluation and brain metabolism evaluation (SPECT scan). A similar evaluation will be done after the 8 weeks, test versus control time period, and another evaluation will be held after 16 weeks. The HBOT procedure will be performed in the hyperbaric chamber at Assaf Harofeh Medical Center, Israel.

The following HBOT protocol will be applied for the treated group: 8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA. After 8 weeks the control group, that did not received HBOT, will receive the same HBOT protocols.

At baseline, after 2 months and after 4 months all patients will undergo complete neurologic and pain evaluation and brain SPECT scan (total of 3 evaluation and scan per patient).

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
45 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •fibromyalgia diagnosed by physical examination of pain sensitivity, by Dolorimeter and finger pressure.

排除标准

  • •any past hyperbaric oxygen therapy
  • •chest x-ray pathology which does not allow the income into the hyperbaric chamber.
  • •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

Crossed group

Other

no active intervention during the first 2 months.After 2 months will be crossed to HBOT

干预措施: Hyperbaric oxygen (Other)

Hyperbaric oxygen therapy group

Active Comparator

hyperbaric oxygen therapy during the first 2 months

干预措施: Hyperbaric oxygen (Other)

结局指标

主要结局

Pain evaluation

时间窗: up to 4 months

次要结局

  • Quality of Life(0,2,4 months)
  • Brain SPECT scan(0,2,4 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Judith Ben Zvi

medical center

Assaf-Harofeh Medical Center

研究点 (1)

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