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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01943929
Other study ID # IIEP 1392-11
Secondary ID
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


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
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