Correlation Between Headaches and Septum and Nasal Mucosa Contact
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01943929|
Recruitment Status : Unknown
Verified September 2013 by Yves Bohrer Costa, Hospital Israelita Albert Einstein.
Recruitment status was: Recruiting
First Posted : September 17, 2013
Last Update Posted : September 17, 2013
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.
|Condition or disease|
|Nasal Septum Deviation Headache|
|Study Type :||Observational|
|Estimated Enrollment :||2000 participants|
|Official Title:||Correlation Between Headaches and Septum and Nasal Mucosa Contact|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||April 2014|
- Complain of Headache during last 3 months (binary response - question answered by the patient at the moment of CT scan) [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01943929
|Contact: Yves B Costa, MD||55(11)firstname.lastname@example.org|
|Hospital Israelita Albert Einstein||Recruiting|
|São Paulo, Brazil, 05652901|
|Contact: Yves B Costa, MD 55(11)21514100 email@example.com|
|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|
|Principal Investigator:||Yves B Costa, MD||Hospital Israelita Albert Einstein|
|Study Director:||Ellison F Cardoso, MD||Hospital Israelita Albert Einstein|