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

Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355160
• Other study ID #: 23218EP
• Status: Completed
• Phase: N/A
• First received: July 19, 2006
• Last updated: May 13, 2013
• Start date: July 2006
• Est. completion date: April 2009

Study information

• Verified date: May 2013
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Facial Pain
• Facies
• Headache
• Rhinitis
• Sinusitis

Locations

Country	Name	City	State
United States	Penn State College of Medicine, Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache subtype	Questionnaire study - headache subtype determined by data provided. No clinical intervention.	completion of questionnaire	No

External Links

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