Non-Rhinologic Etiologies of Headaches and Facial Pain in Tertiary Care Setting

May 13, 2013 updated by: Johnathan McGinn, Penn State University
The study serves to investigate the type and prevalence of non-rhinologic headaches seen through a academic otolaryngology practice.The study encompasses survey questionnaires, review of CT images, and physical examination/nasal endoscopy findings.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

  1. Rationale Our aim is to conduct a prospective study to assess the patients referred for rhinosinusitis to a tertiary rhinologic practice whose symptoms include headache/facial pain, but have no evidence of significant rhinologic disease and determine whether a neurologic etiology is responsible for headaches or facial pressure/pain symptoms.
  2. Key Objectives 1. Assess prevalence of headache syndromes in patients with primary complaints of facial pain and headaches. 2. Correlate average Lund McKay CT scan score in patients with headache syndromes
  3. Study Population Patients referred to Dr. McGinn's otorhinolaryngologic practice for assessment of rhinosinusitis who do not meet the criteria for the diagnosis of rhinosinusitis.
  4. Major Inclusion & Exclusion Criteria Inclusion criteria include patients greater than 18 years of age, literate in the English language, referred by a physician for primary complaint of "sinusitis", major symptomatic complaint of headache or facial pain/pressure, CT scan must have been performed prior and available for review at the time of visit. Exclusion criteria include evidence of chronic rhinosinusitis, a modified LM score greater than 2, pregnancy, history of prior facial trauma or tumor in the head and neck region, specifically the nasal area, past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis).
  5. Allocation to Groups None
  6. Procedures: Participants will be asked to complete a headache questionnaire and the SNOT-20 questionnaire (a validated tool developed by Dr. Picirillo). Information from the subjects' medical records related to their headaches and facial pain will be recorded for the research. This information will include the results of the CT scan, nasal endoscopic exam, and clinical exam.
  7. Major Risks and Discomforts: Loss of confidentiality.
  8. Confidentiality: No patient names or other identifying information will be revealed in the course of the study. There will be no direct patient identifiers on the database utilized for this study. The initial patient form scanned into the database will utilize a coded identifier based on chronological order in order to prevent inadvertent disclosure of private medical data. The code will be kept secure in a locked filing cabinet in the principal investigator's office and destroyed once the data are collected and the study is completed.
  9. Investigator Qualifications & Specific Roles in the Research Johnathan M. McGinn, MD is a board certified otolaryngologist.
  10. Study Site Location(s) - Hershey Medical Center outpatient clinic

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pateints presenting to our clinic with a diagnosis of "sinusitis" by referring physicians with facial pain and/or headache as key complaint, ut who have no clincal evidence of sinusitis by CT scan or examination

Description

Inclusion Criteria:

  • patients greater than 18 years of age
  • literate in the English language
  • referred by a physician for primary complaint of "sinusitis"
  • major symptomatic complaint of headache or facial pain/pressure
  • CT scan must have been performed prior and available for review at the time of visit

Exclusion Criteria:

  • evidence of chronic rhinosinusitis
  • a modified Lund Mackay score greater than 2 on CT
  • pregnancy
  • history of prior facial trauma or tumor in the head and neck region, specifically the nasal area
  • past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Headache subtype
Time Frame: completion of questionnaire
Questionnaire study - headache subtype determined by data provided. No clinical intervention.
completion of questionnaire

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Penn State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Johnathan D McGinn, MD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2009

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2009

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 19, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 19, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 15, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23218EP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings