Correlation Between Headaches and Septum and Nasal Mucosa Contact

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.

Study Overview

• Status: Unknown
• Conditions: Headache; Nasal Septum Deviation

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Yves B Costa, MD; Phone Number: 55(11)21514100; Email: yves.costa@einstein.br

Study Locations

• Brazil
  • São Paulo, Brazil, 05652901
    • Recruiting
    • Hospital Israelita Albert Einstein
    • Contact: Yves B Costa, MD; Phone Number: 55(11)21514100; Email: yves.costa@einstein.br
    • Principal Investigator: Yves B Costa, MD
    • Sub-Investigator: Evelyn N Azevedo
    • Sub-Investigator: Ellison F Cardoso, MD
    • Sub-Investigator: Benjamin W Handfas, MD
    • Sub-Investigator: Regina L Gomes, PhD
    • Sub-Investigator: Mauro M Daniel, PhD
    • Sub-Investigator: Marcio RT Garcia, MD
    • Sub-Investigator: Carolina R Soares, MD
    • Sub-Investigator: Paulo Monzillo, MD
    • Sub-Investigator: Patricia Netmoto, MD
    • Sub-Investigator: Marcelo G Funari, PhD
    • Sub-Investigator: Daniel V Sumi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with clinical history of trauma

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complain of Headache during last 3 months (binary response - question answered by the patient at the moment of CT scan)	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.	within less than a day from the date that CT scan is performed

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Yves B Costa, MD, Hospital Israelita Albert Einstein; Study Director: Ellison F Cardoso, MD, Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Anticipated): March 1, 2014
• Study Completion (Anticipated): April 1, 2014

Study Registration Dates

• First Submitted: December 7, 2012
• First Submitted That Met QC Criteria: September 12, 2013
• First Posted (Estimate): September 17, 2013

Study Record Updates

• Last Update Posted (Estimate): September 17, 2013
• Last Update Submitted That Met QC Criteria: September 12, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: Headache; Nasal septum; Mucosa contact point headache
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Headache
• Other Study ID Numbers: IIEP 1392-11