NCT00355160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2006

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 21, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

May 15, 2013

Status Verified

May 1, 2013

Enrollment Period

2.8 years

First QC Date

July 19, 2006

Last Update Submit

May 13, 2013

Conditions

HeadacheSinusitisRhinitisFacial Pain

Keywords

HeadacheSinusitisRhinitisFacial Pain

Outcome Measures

Primary Outcomes (1)

  • Headache subtype

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

    completion of questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Links

MeSH Terms

Conditions

HeadacheSinusitisRhinitisFacial Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Johnathan D McGinn, MD

    Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2006

First Posted

July 21, 2006

Study Start

July 1, 2006

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

May 15, 2013

Record last verified: 2013-05

Locations

US(1)