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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnathan McGinn, Penn State University
ClinicalTrials.gov Identifier:
NCT00355160
First received: July 19, 2006
Last updated: May 13, 2013
Last verified: May 2013
  Purpose

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.


Condition
Headache
Sinusitis
Rhinitis
Facial Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Rhinologic Etiologies of Headaches and Facial Pain in Tertiary Care Setting

Resource links provided by NLM:


Further study details as provided by Penn State University:

Primary Outcome Measures:
  • Headache subtype [ Time Frame: completion of questionnaire ] [ Designated as safety issue: No ]
    Questionnaire study - headache subtype determined by data provided. No clinical intervention.


Enrollment: 20
Study Start Date: July 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355160

Locations
United States, Pennsylvania
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Penn State University
Investigators
Principal Investigator: Johnathan D McGinn, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: Johnathan McGinn, Associate Professor, Penn State University
ClinicalTrials.gov Identifier: NCT00355160     History of Changes
Other Study ID Numbers: 23218EP
Study First Received: July 19, 2006
Last Updated: May 13, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Penn State University:
Headache
Sinusitis
Rhinitis
Facial Pain

Additional relevant MeSH terms:
Facial Pain
Facies
Headache
Rhinitis
Sinusitis
Disease Attributes
Nervous System Diseases
Neurologic Manifestations
Nose Diseases
Otorhinolaryngologic Diseases
Pain
Paranasal Sinus Diseases
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections
Signs and Symptoms

ClinicalTrials.gov processed this record on October 20, 2014