Clinical trial NCT01001039: Validation of the Facial and Cephalic Pain Inventory
Official title: Validation of the FAcial and CEphalic PAin INventory (FACE PAIN)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sinusitis
Keywords: chronic sinusitis
facial pain
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Case subjects from the Rhinology Clinic must have CT evidence of chronic sinusitis
* Control subject from the Otology Clinic who have not had sinus surgery in the past 2 months

Exclusion Criteria:

* any subject unable to give informed consent of complete self-administered questionnaires written in English
* Control subjects with a history of sinusitis in the last 6 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Rhinology Clinic
state: Washington
Study officials:
affiliation: University of Washington
name: Greg E Davis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: