Correlation Between Headaches and Septum and Nasal Mucosa Contact

NCT01943929 | Unknown

• 1 other identifier: IIEP 1392-11
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Septum Deviation; Headache

Keywords

Nasal septum; Headache; Mucosa contact point headache

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patients with clinical history of trauma

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652901, Brazil

RECRUITING

MeSH Terms

Conditions

Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yves B Costa, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Ellison F Cardoso, MD

  Hospital Israelita Albert Einstein

  STUDY DIRECTOR

Central Study Contacts

Yves B Costa, MD

CONTACT

55(11)21514100; yves.costa@einstein.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: September 17, 2013
• Study Start: November 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: September 17, 2013

Record last verified: 2013-09

Locations

BR (1)