SinusitisFACE PAINNCT01001039
Validation of the Facial and Cephalic Pain Inventory
An observational study of Sinusitis, run by Greg Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinusitis
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Rhinology Clinic
Seattle, Washington, 98195
About this study
Official title: Validation of the FAcial and CEphalic PAin INventory (FACE PAIN)
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.
Read the 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.
- Conditions
- Sinusitis
- Keywords
- chronic sinusitis, facial pain
- Medical subject headings
- Sinusitis, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Greg Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Greg Davis, University of Washington
- Investigators
- Greg E Davis, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001039
- Sponsor's protocol ID
- 37055-E/A
- Acronym
- FACE PAIN
- Status last verified
- Jun 2012
- First submitted
- 21 Oct 2009
- Last updated
- 29 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the FAcial and CEphalic PAin INventory (FACE PAIN)
- ClinicalTrials.gov ID
- NCT01001039
- Acronym / sponsor ID
- FACE PAIN / 37055-E/A
- Conditions
- Sinusitis
- Keywords
- chronic sinusitis, facial pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Greg DavisUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 23 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Greg E Davis, MD, MPH principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sinusitis, run by Greg Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2012.