An observational study in Sinusitis, sponsored by Greg Davis. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-06-29.
Sponsored by Greg Davis · Observational
This study proposes to develop and validate a new instrument designed to measure facial and nasal discomfort related to chronic sinusitis. The second phase of the study will be to use this instrument to measure correlation with sinus computed tomography (CT) scans.
The following specific aims will be addressed:
The measurements used for the study are: demographics (age, gender and race), contact information (to facilitate mailing of future instruments), Sinonasal Outcome Test-20 (SNOT-20 - a well validated, 20-item measure of rhinosinusitis specific QOL), FAcial and CEphalic PAin INventory (instrument under study) and Translational Quality of Life Form (this transition scale provides a subjective quantification of the degree of change in quality of life from sinusitis); CT scans and nasal endoscopy findings.
Control subjects will complete the SNOT-20 (validated QOL form) and the FACE PAIN a single time.
Case subjects will complete the SNOT-20 and the FACE PAIN questionnaire at the visit during which they review their CT results with the MD. Thereafter, they will complete the FACE PAIN questionaire twice more; at weeks 12 and 14 post that visit. They will also complete the Transition Scale at week 12. These forms will be mailed to the subjects and returned by mail.
We hypothesize that facial pain ratings will correlate moderately with SNOT-20 scores and a transition scale. Higher values are not expected because QOL instruments encompass many symptoms of chronic sinusitis, but the FACE PAIN instrument addresses location and severity of pain.
We will also test the hypothesis that facial pain ratings will be much lower in non-sinusitis patients.
415 studies on the registry are indexed under Sinusitis; 46 are open to participants now.
This study's enrollment of 68 is below the median of 110 across 76 observational studies indexed under Sinusitis.
Browse Sinusitis studies →Greg Davis is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the Rhinology Clinic with a complaint of facial pain and evidence of chronic sinusitis. Control subjects will be patients presenting to the Otology Clinic with no evidence of sinusitis.
Exclusion Criteria:
Patients seen in the Otology clinic who have not had sinus surgery in the past 2 months or a history of sinusitis in the last 6 months.
Patients seen in the Rhinology Clinic with a complaint of facial pain. They must have evidence of chronic sinusitis.
This study is completed, as verified in Jun 2012. You cannot join it, but the record below documents what was studied.
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