Correlation Between Headaches and Septum and Nasal Mucosa Contact

Headache Clinical Trial

Official title:

Correlation Between Headaches and Septum and Nasal Mucosa Contact

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01943929
• Other study ID #: IIEP 1392-11
• Status: Recruiting
• Phase: N/A
• First received: December 7, 2012
• Last updated: September 12, 2013
• Start date: November 2012
• Est. completion date: April 2014

Study information

• Verified date: September 2013
• Source: Hospital Israelita Albert Einstein
• Contact: Yves B Costa, MD
• Phone: 55(11)21514100
• Email: yves.costa[@]einstein.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: April 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with clinical history of trauma

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Headache
• Nasal Septum Deviation
• Nose Deformities, Acquired

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No