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临床试验/NCT01943929
NCT01943929Unknown不适用

Correlation Between Headaches and Septum and Nasal Mucosa Contact

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
2,000
试验地点
1
主要终点
Complain of Headache during last 3 months (binary response - question answered by the patient at the moment of CT scan)

研究概览

简要总结

Headache is the most common complaint to neurologists. In the 80´s and 90's few papers, with limited number of patients, have proposed the association between nasal septum contact and headache. The International Classification of Headaches Disorders proposed specific diagnostic criteria for this entity.

With the major use of CT scans, the contact between nasal mucosa and septum is daily observed in many patients without complaint of headache.

The purpose of this study is to determine if there is any correlation between nasal and septum mucosa contact and the prevalence of headache. The investigators hypothesized that no correlation will be found using CT scans in a large series of patients.

详细描述

Every patient older than 18 years old whom underwent sinuses or facial computed tomography will be asked to answer a questionnaire, where he will be able to describe his headache features (if present) . This information will be correlated with patient images findings, which are going to be evaluated by head and neck radiologists blinded for clinical information. Logistic regression model will be used to verify this association; the presence of sinusitis and fever will used be as covariates.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • All patients older than 18 years whom underwent sinuses or facial tomography.

排除标准

  • Patients with clinical history of trauma

结局指标

主要结局

Complain of Headache during last 3 months (binary response - question answered by the patient at the moment of CT scan)

时间窗: within less than a day from the date that CT scan is performed

In order to analyze the effect of nasal mucosal contact points explaining the presence of headache we are going to perform a logistic regression model with the following explanatory variables: grade and location of the contact between nasal septum and nasal mucosa (8 dummy variables) and history of previous nasal surgery. Our hypothesis is that the presence of headache will not be explained by any of these variables. In addition we will also include in this model the following variables: fever, tomographic signs of sinusitis, obliteration of nasal sinus pathways, gender.

次要结局

未报告次要终点

研究者

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

Yves Bohrer Costa

MD

Hospital Israelita Albert Einstein

研究点 (1)

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