Correlation Between Headaches and Septum and Nasal Mucosa Contact

• Conditions: Nasal Septum Deviation; Headache

• Registration Number: NCT01943929
• Lead Sponsor: Hospital Israelita Albert Einstein

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-12-07
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-12
• Last Update Submitted: 2013-09-12
• Study First Posted: 2013-09-17
• Last Update Posted: 2013-09-17
• Primary Completion: 2014-03
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• Patients with clinical history of trauma

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 São Paulo, Brazil