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Correlation Between Headaches and Septum and Nasal Mucosa Contact

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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
Sponsor:
Information provided by (Responsible Party):
Yves Bohrer Costa, 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.


Condition or disease
Nasal Septum Deviation Headache

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
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients older than 18 years whom underwent sinuses or facial tomography.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients with clinical history of trauma

Information from the National Library of Medicine

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


Contacts
Contact: Yves B Costa, MD 55(11)21514100 yves.costa@einstein.br

Locations
Brazil
Hospital Israelita Albert Einstein Recruiting
São Paulo, Brazil, 05652901
Contact: Yves B Costa, MD    55(11)21514100    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         
Sponsors and Collaborators
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

Responsible Party: Yves Bohrer Costa, MD, Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT01943929     History of Changes
Other Study ID Numbers: IIEP 1392-11
First Posted: September 17, 2013    Key Record Dates
Last Update Posted: September 17, 2013
Last Verified: September 2013

Keywords provided by Yves Bohrer Costa, Hospital Israelita Albert Einstein:
Nasal septum
Headache
Mucosa contact point headache

Additional relevant MeSH terms:
Headache
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms