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Status unknownNCT01943929Updated Sep 17, 2013

Correlation Between Headaches and Septum and Nasal Mucosa Contact

An observational study in Nasal Septum Deviation and Headache, sponsored by Hospital Israelita Albert Einstein. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-17.

Sponsored by Hospital Israelita Albert Einstein · Observational

The sponsor has not verified this record recently (last verified Sep 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
2,000
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Nasal Septum Deviation
  • Headache

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Keywords

  • Nasal septum
  • Headache
  • Mucosa contact point headache
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In context

Headache

1,225 studies on the registry are indexed under Headache; 201 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 120 across 257 observational studies indexed under Headache.

Browse Headache studies →

Lead sponsor

Hospital Israelita Albert Einstein is the lead sponsor of 143 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patients with clinical history of trauma
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
2,000 participants (estimated)
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What researchers measure

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.

    Time frame: within less than a day from the date that CT scan is performed

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Study locations

1 of 1 sites recruiting
  • Hospital Israelita Albert Einstein
    São Paulo, 05652901, Brazil
    • Yves B Costa, MD · Contact · yves.costa@einstein.br · 55(11)21514100
    • Yves B Costa, MD · Principal 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 · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01943929
Lead sponsor
Hospital Israelita Albert Einstein
Responsible party
Yves Bohrer Costa (MD, Hospital Israelita Albert Einstein) — Principal investigator
First posted
Sep 17, 2013
Start date
Nov 2012
Primary completion
Mar 2014 (estimated)
Completion
Apr 2014 (estimated)
Last update
Sep 17, 2013

Study contacts

Yves B Costa, MD
Contact
yves.costa@einstein.br
55(11)21514100
Yves B Costa, MD
principal investigator · Hospital Israelita Albert Einstein
Ellison F Cardoso, MD
study director · Hospital Israelita Albert Einstein

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.

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