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临床试验/NCT00991042
NCT00991042已完成1 期

Analytical Transversal Study of Cytokines Serum Levels in Chronic Low Back Pain Due to Herniated Disk

Federal University of São Paulo1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2003年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
23
试验地点
1
主要终点
cytokines levels in patients with chronic low back pain and in healthy subjects

研究概览

简要总结

The purpose of this study is to:

  • evaluate if there is an association between elevated levels of cytokines and chronic pain due to herniated disk disease
  • measured cytokines levels in chronic low back pain and in healthy subjects.

详细描述

23 patients with at least three months of back pain due to herniated disk disease were selected Diagnosis was confirmed by magnetic resonance imaging (MRI) or computerized tomography (CT) imaging of the spine for all patients. In addition, pain severity had to be ³ 5 points on the Numerical Rating Scale (NRS) ranging from zero (no pain) to 10 (worst imaginable pain).

The exclusion criteria were defined as one or more of the following: psychiatric disorders, systemic or inflammatory disease, history of allergy, presence of motor deficits, history of blood dyscrasia, pregnancy, active infection, tumor, use of analgesic drugs in the week before or inability to come to the hospital for evaluation.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 23 patients
  • least three months of back pain due to herniated disk disease
  • pain severity had to be 5 points on the Numerical Rating Scale (NRS)
  • 10 healthy volunteers:
  • without previous history of back pain

排除标准

  • One or more of the following:
  • psychiatric disorders
  • systemic or inflammatory disease
  • history of allergy
  • presence of motor deficits
  • history of blood dyscrasia
  • pregnancy
  • active infection, tumor
  • use of analgesic drugs in the week before
  • inability to come to the hospital for evaluation.

结局指标

主要结局

cytokines levels in patients with chronic low back pain and in healthy subjects

时间窗: 30 days after collect

次要结局

未报告次要终点

研究者

发起方
Federal University of São Paulo
申办方类型
Other

研究点 (1)

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