Validation of the Facial & Cephalic Pain Inventory

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Sinusitis

Clinical Trial Details

NCT number	NCT01001039
Study type	Observational
Source	University of Washington
Contact
Status	Completed
Phase	N/A
Start date	October 2009
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT03584178` - The Long-Term Safety of Budesonide for Patients With Chronic Rhinosinusitis	N/A
Completed	`NCT06016335` - MRI-based Synthetic CT Images of the Head and Neck	N/A
Active, not recruiting	`NCT02278484` - Sinus Balloon Dilation in Pediatric Patients	N/A
Withdrawn	`NCT02071667` - Association of Periostin Levels and Chronic Sinusitis	N/A
Completed	`NCT01420471` - Medicated Punctured-Glove-Finger Spacer Study	Phase 4
Completed	`NCT01118312` - Study of Asthma and Nasal Steroids	Phase 4
Completed	`NCT00645762` - Balloon REmodeling Antrostomy THErapy Study	Phase 2
Completed	`NCT01685229` - Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
Active, not recruiting	`NCT03943121` - The Effects of Steroid-eluting Stent Implant for the Treatment of Eosinophilic Chronic Rhinosinusitis With Nasal Polyps	N/A
Withdrawn	`NCT02900794` - Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery	N/A
Terminated	`NCT02630472` - Topical Irrigation Therapy for CRS	Phase 1/Phase 2
Completed	`NCT01442740` - 15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients	N/A
Completed	`NCT01033799` - Effect of the Consumption of a Fermented Milk on Common Infections in Shift-workers	N/A
Completed	`NCT00242437` - Hemostatic Matrix in Endoscopic Sinus Surgery	Phase 4
Completed	`NCT00335309` - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis	N/A
Completed	`NCT00236522` - A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults.	Phase 3
Completed	`NCT01717274` - Hot Saline Irrigation Study	N/A
Completed	`NCT01166945` - Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children	N/A
Not yet recruiting	`NCT00545961` - Middle Meatal Bacteriology During Acute Respiratory Infection in Children	Phase 4
Completed	`NCT00747747` - Sinuclean's Treatment Of Sinusitis' Symptoms	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Validation of the Facial and Cephalic Pain Inventory — FACE PAIN

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms