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临床试验/NCT04125576
NCT04125576Unknown不适用

Comparison of Pain-Related Changes in Cerebral Blood Volume in Burn Patients With Neuropathic Pain

Hangang Sacred Heart Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年10月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
cerebral blood volume

研究概览

简要总结

The investigators will observe increased or decreased CBV in patients with thermal injury compared with the CBV in healthy controls.

详细描述

Prevalence of chronic pain has been shown to be high after thermal injury. Post-burn neuropathic pain causes chronic disabilities that is often difficult to treat effectively.

To study changes in the pain network associated with neuropathic pain, magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) in patients who was injuried by burn. Over the fifty participants will be recruited. The participants will be comprised 30 subjects with neuropathic pain caused by thermal injury and 20 healthy contols. The 30 patients with neuropathic pain will be comprised divided into 15 electrical injury group and 15 non-electrical burn injury group. The patients are included the patients with severe neuropathic pain that is rated at least 5 on the visual analogue scale (VAS), despite treatments with gabapentin medication and other physical modalities. The intensity of neuropathic pain will be measured using the visual analogue scale(VAS). Depressive mood will be assessed using the Beck Depression Scale. CBV maps will be compared between burn patients and controls. And the relationship between individual participant CBV(measured in voxels), BDS and VAS score will be also examined.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Burn patients
  • severe neuropatic pain rated at least 5 on the 10-point numerical rating scale (NRS).

排除标准

  • cardiac arrest history
  • history of neurologic disease or brain surgery
  • unstable heart disease or presence of a cardiac pacemaker
  • psychiatric disorder
  • diabetes mellitus
  • abnormal renal function
  • contraindication for MRI
  • pregnancy.

结局指标

主要结局

cerebral blood volume

时间窗: 1 week

magnetic resonance imaging(MRI) was used to evaluate cerebral blood volume(CBV) of pain network

次要结局

  • visual analogue scale(1 week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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