NCT00735735终止不适用
Study of the Measurement of Substance P in the Saliva of Patients With Low Back Pain
Kovacs Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2009年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Levels of Substance P in the saliva
研究概览
简要总结
The purpose of this study is to compare the levels of Substance P in saliva, in patients with severe chronic low back pain and in subjects without it. In addition, to explore a possible cutoff point, in order to define normal and pathological levels of Substance P in saliva. The ultimate objective would be to design a measurement method for use in routine clinical practice.
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients referred to the Kovacs Back Pain Unit in Palma de Mallorca for chronic low back pain
- •A pain level of 6 or greater on the PI-NRS scale (0=no pain, 10= worst pain possible)
- •Seen at the Unit between 9 and 13 hours (due to the circadian rhythm of Substance P in saliva and to avoid great variability in the results)
- •For healthy subjects:
- •Volunteers with no pain (anywhere)
- •That in the past year have had no more than 40 days with pain, and no episode of more than 7 days of continuous pain.
排除标准
- •Subjects with pain that is additional to or different from chronic low back pain
结局指标
主要结局
Levels of Substance P in the saliva
时间窗: 12 months
次要结局
未报告次要终点
研究者
Francisco M. Kovacs
Director of Scientific Department, Kovacs Foundation
Kovacs Foundation
研究点 (2)
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