Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Validation of the Facial and Cephalic Pain Inventory (FACE PAIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Greg Davis, University of Washington
ClinicalTrials.gov Identifier:
NCT01001039
First received: October 21, 2009
Last updated: June 27, 2012
Last verified: June 2012
  Purpose

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.


Condition
Sinusitis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the FAcial and CEphalic PAin INventory (FACE PAIN)

Resource links provided by NLM:


Further study details as provided by University of Washington:

Enrollment: 68
Study Start Date: October 2009
Study Completion Date: June 2012
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
control
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.
cases
Patients seen in the Rhinology Clinic with a complaint of facial pain. They must have evidence of chronic sinusitis.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01001039

Locations
United States, Washington
University of Washington Rhinology Clinic
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Greg Davis
Investigators
Principal Investigator: Greg E Davis, MD, MPH University of Washington
  More Information

No publications provided

Responsible Party: Greg Davis, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01001039     History of Changes
Other Study ID Numbers: 37055-E/A
Study First Received: October 21, 2009
Last Updated: June 27, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
chronic sinusitis
facial pain

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on November 20, 2014