MedDataX Logo

Correlation Between Headaches and Septum and Nasal Mucosa Contact

NCT ID: NCT01943929

Last Updated: 2013-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nasal Septum Deviation Headache

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Nasal septum Headache Mucosa contact point headache

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Patients with clinical history of trauma
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yves Bohrer Costa

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Yves B Costa, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Ellison F Cardoso, MD

Role: STUDY_DIRECTOR

Hospital Israelita Albert Einstein

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Yves B Costa, MD

Role: CONTACT

Phone: 55(11)21514100

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Yves B Costa, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IIEP 1392-11

Identifier Type: -

Identifier Source: org_study_id