Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01001039
Other study ID # 37055-E/A
Secondary ID
Status Completed
Phase N/A
First received October 21, 2009
Last updated June 27, 2012
Start date October 2009
Est. completion date June 2012

Study information

Verified date June 2012
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 2012
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Washington Rhinology Clinic Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
Greg Davis

Country where clinical trial is conducted

United States, 

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 NCT00335309 - Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis N/A
Completed NCT00242437 - Hemostatic Matrix in Endoscopic Sinus Surgery Phase 4
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
Not yet recruiting NCT06089278 - A Clinical Study of TQH2722 Injection in the Treatment of Chronic Sinusitis With or Without Nasal Polyps. Phase 2
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