Validation of the Facial and Cephalic Pain Inventory

The following specific aims will be addressed:

- to create a user-friendly, self-explanatory instrument (FACE PAIN questionnaire) with
pain severity visual analog scales associated with the common locations of facial pain
in chronic sinusitis.

- to evaluate the clinimetric reliability and validity of the FACE PAIN questionnaire

- to evaluate the ability of th FACE PAIN questionnaire to detect change in symptoms
following medical or surgical treatment

- to quantify a minimally important difference in the FACE PAIN instrument by correlating
disease-specific quality of life change (Transition Scale) with FACE PAIN rating
changes following treatment.

- to evaluate the correlation between facial pain symptoms described on the FACE PAIN
questionnaire with CT scan and endoscopic findings.

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.