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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355160
Recruitment Status : Completed
First Posted : July 21, 2006
Last Update Posted : May 15, 2013
Sponsor:
Information provided by (Responsible Party):
Johnathan McGinn, Penn State University

Tracking Information
First Submitted Date July 19, 2006
First Posted Date July 21, 2006
Last Update Posted Date May 15, 2013
Study Start Date July 2006
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2013)
Headache subtype [ Time Frame: completion of questionnaire ]
Questionnaire study - headache subtype determined by data provided. No clinical intervention.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Rhinologic Etiologies of Headaches and Facial Pain in Tertiary Care Setting
Official Title Non-Rhinologic Etiologies of Headaches and Facial Pain in Tertiary Care Setting
Brief 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition
  • Headache
  • Sinusitis
  • Rhinitis
  • Facial Pain
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 13, 2013)
20
Original Enrollment
 (submitted: July 19, 2006)
35
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility 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).
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00355160
Other Study ID Numbers 23218EP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Johnathan McGinn, Penn State University
Study Sponsor Penn State University
Collaborators Not Provided
Investigators
Principal Investigator: Johnathan D McGinn, MD Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
PRS Account Penn State University
Verification Date May 2013