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

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ClinicalTrials.gov Identifier: NCT01001039
Recruitment Status : Completed
First Posted : October 23, 2009
Last Update Posted : June 29, 2012
Sponsor:
Information provided by (Responsible Party):
Greg Davis, University of Washington

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.

Condition or disease
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.


Study Type : Observational
Actual Enrollment : 68 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of the FAcial and CEphalic PAin INventory (FACE PAIN)
Study Start Date : October 2009
Primary Completion Date : July 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Group/Cohort
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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Greg Davis, Assistant Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01001039     History of Changes
Other Study ID Numbers: 37055-E/A
First Posted: October 23, 2009    Key Record Dates
Last Update Posted: June 29, 2012
Last Verified: June 2012

Keywords provided by Greg Davis, University of Washington:
chronic sinusitis
facial pain

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