CClinicalTrials.gg
Sign In
CompletedNCT00355160Updated May 15, 2013

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

An observational study in Headache, Sinusitis and Rhinitis, sponsored by Penn State University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-15.

Sponsored by Penn State University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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
02

Conditions studied

  • Headache
  • Sinusitis
  • Rhinitis
  • Facial Pain

Keywords

  • Headache
  • Sinusitis
  • Rhinitis
  • Facial Pain
03

In context

Rhinitis

1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.

This study's enrollment of 20 is below the median of 141 across 172 observational studies indexed under Rhinitis.

Browse Rhinitis studies →

Lead sponsor

Penn State University is the lead sponsor of 263 studies on the registry; 51 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 10 (77%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
06

What researchers measure

Primary outcomes

  1. Headache subtype

    Questionnaire study - headache subtype determined by data provided. No clinical intervention.

    Time frame: completion of questionnaire

07

Study locations

1 site
  • Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
08

References and documents

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00355160
Lead sponsor
Penn State University
Responsible party
Johnathan McGinn (Associate Professor, Penn State University) — Principal investigator
First posted
Jul 21, 2006
Start date
Jul 2006
Primary completion
Apr 2009
Completion
Apr 2009
Last update
May 15, 2013

Study contacts

Johnathan D McGinn, MD
principal investigator · Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Oversight

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

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Rhinitis→

Other studies from this sponsor

Penn State University

Start the discussion