HeadacheNCT00355160
Non-Rhinologic Etiologies of Headaches and Facial Pain in Tertiary Care Setting
An observational study of Headache and Sinusitis, run by Penn State University at 1 site in United States.
Trial summary
The study serves to investigate the type and prevalence of non-rhinologic headaches seen through a academic otolaryngology practice.The study encompasses survey questionnaires, review of CT images, and physical examination/nasal endoscopy findings. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to Apr 2009
- 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: Pateints presenting to our clinic with a diagnosis of "sinusitis" by referring physicians with facial pain and/or headache as key complaint, ut who have no clincal evidence of sinusitis by CT scan or examination
Who may be able to join
- patients greater than 18 years of age
- literate in the English language
- referred by a physician for primary complaint of "sinusitis"
- major symptomatic complaint of headache or facial pain/pressure
- CT scan must have been performed prior and available for review at the time of visit
Who cannot join
- evidence of chronic rhinosinusitis
- a modified Lund Mackay score greater than 2 on CT
- pregnancy
- history of prior facial trauma or tumor in the head and neck region, specifically the nasal area
- past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis).
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
The study serves to investigate the type and prevalence of non-rhinologic headaches seen through a academic otolaryngology practice.The study encompasses survey questionnaires, review of CT images, and physical examination/nasal endoscopy findings.
Read the detailed description
- Rationale Our aim is to conduct a prospective study to assess the patients referred for rhinosinusitis to a tertiary rhinologic practice whose symptoms include headache/facial pain, but have no evidence of significant rhinologic disease and determine whether a neurologic etiology is responsible for headaches or facial pressure/pain symptoms.
- Key Objectives 1. Assess prevalence of headache syndromes in patients with primary complaints of facial pain and headaches. 2. Correlate average Lund McKay CT scan score in patients with headache syndromes
- Study Population Patients referred to Dr. McGinn's otorhinolaryngologic practice for assessment of rhinosinusitis who do not meet the criteria for the diagnosis of rhinosinusitis.
- Major Inclusion \& Exclusion Criteria Inclusion criteria include patients greater than 18 years of age, literate in the English language, referred by a physician for primary complaint of "sinusitis", major symptomatic complaint of headache or facial pain/pressure, CT scan must have been performed prior and available for review at the time of visit. Exclusion criteria include evidence of chronic rhinosinusitis, a modified LM score greater than 2, pregnancy, history of prior facial trauma or tumor in the head and neck region, specifically the nasal area, past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis).
- Allocation to Groups None
- Procedures: Participants will be asked to complete a headache questionnaire and the SNOT-20 questionnaire (a validated tool developed by Dr. Picirillo). Information from the subjects' medical records related to their headaches and facial pain will be recorded for the research. This information will include the results of the CT scan, nasal endoscopic exam, and clinical exam.
- Major Risks and Discomforts: Loss of confidentiality.
- Confidentiality: No patient names or other identifying information will be revealed in the course of the study. There will be no direct patient identifiers on the database utilized for this study. The initial patient form scanned into the database will utilize a coded identifier based on chronological order in order to prevent inadvertent disclosure of private medical data. The code will be kept secure in a locked filing cabinet in the principal investigator's office and destroyed once the data are collected and the study is completed.
- Investigator Qualifications \& Specific Roles in the Research Johnathan M. McGinn, MD is a board certified otolaryngologist.
- Study Site Location(s) - Hershey Medical Center outpatient clinic
- Conditions
- Headache, Sinusitis, Rhinitis, Facial Pain
- Keywords
- Headache, Sinusitis, Rhinitis, Facial Pain
- Medical subject headings
- Headache, Sinusitis, Rhinitis, Facial Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache subtype
Questionnaire study - headache subtype determined by data provided. No clinical intervention.
Measured: completion of questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2006 (estimated)
- Study startJul 2006
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HeadacheStudies of the same condition, open and under way.
- More trials run by Penn State UniversityThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Penn State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johnathan McGinn, Penn State University
- Investigators
- Johnathan D McGinn, MD, Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00355160
- Sponsor's protocol ID
- 23218EP
- Status last verified
- May 2013
- First submitted
- 19 Jul 2006
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Rhinologic Etiologies of Headaches and Facial Pain in Tertiary Care Setting
- ClinicalTrials.gov ID
- NCT00355160
- Acronym / sponsor ID
- 23218EP
- Conditions
- Headache, Sinusitis, Rhinitis, Facial Pain
- Keywords
- Headache, Sinusitis, Rhinitis, Facial Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Penn State UniversityUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 21 Jul 2006 (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.
The study serves to investigate the type and prevalence of non-rhinologic headaches seen through a academic otolaryngology practice.The study encompasses survey questionnaires, review of CT images, and physical examination/nasal endoscopy findings.
Detailed description
- Rationale Our aim is to conduct a prospective study to assess the patients referred for rhinosinusitis to a tertiary rhinologic practice whose symptoms include headache/facial pain, but have no evidence of significant rhinologic disease and determine whether a neurologic etiology is responsible for headaches or facial pressure/pain symptoms.
- Key Objectives 1. Assess prevalence of headache syndromes in patients with primary complaints of facial pain and headaches. 2. Correlate average Lund McKay CT scan score in patients with headache syndromes
- Study Population Patients referred to Dr. McGinn's otorhinolaryngologic practice for assessment of rhinosinusitis who do not meet the criteria for the diagnosis of rhinosinusitis.
- Major Inclusion \& Exclusion Criteria Inclusion criteria include patients greater than 18 years of age, literate in the English language, referred by a physician for primary complaint of "sinusitis", major symptomatic complaint of headache or facial pain/pressure, CT scan must have been performed prior and available for review at the time of visit. Exclusion criteria include evidence of chronic rhinosinusitis, a modified LM score greater than 2, pregnancy, history of prior facial trauma or tumor in the head and neck region, specifically the nasal area, past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis).
- Allocation to Groups None
- Procedures: Participants will be asked to complete a headache questionnaire and the SNOT-20 questionnaire (a validated tool developed by Dr. Picirillo). Information from the subjects' medical records related to their headaches and facial pain will be recorded for the research. This information will include the results of the CT scan, nasal endoscopic exam, and clinical exam.
- Major Risks and Discomforts: Loss of confidentiality.
- Confidentiality: No patient names or other identifying information will be revealed in the course of the study. There will be no direct patient identifiers on the database utilized for this study. The initial patient form scanned into the database will utilize a coded identifier based on chronological order in order to prevent inadvertent disclosure of private medical data. The code will be kept secure in a locked filing cabinet in the principal investigator's office and destroyed once the data are collected and the study is completed.
- Investigator Qualifications \& Specific Roles in the Research Johnathan M. McGinn, MD is a board certified otolaryngologist.
- Study Site Location(s) - Hershey Medical Center outpatient clinic
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pateints presenting to our clinic with a diagnosis of "sinusitis" by referring physicians with facial pain and/or headache as key complaint, ut who have no clincal evidence of sinusitis by CT scan or examination
Key inclusion criteria (5 listed)
- patients greater than 18 years of age
- literate in the English language
- referred by a physician for primary complaint of "sinusitis"
- major symptomatic complaint of headache or facial pain/pressure
- CT scan must have been performed prior and available for review at the time of visit
Key exclusion criteria (5 listed)
- evidence of chronic rhinosinusitis
- a modified Lund Mackay score greater than 2 on CT
- pregnancy
- history of prior facial trauma or tumor in the head and neck region, specifically the nasal area
- past history of autoimmune disorder affecting the head and neck region (e.g., Wegener's granulomatosis).
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
Headache subtype
Time frame: completion of questionnaire
Questionnaire study - headache subtype determined by data provided. No clinical intervention.
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 15 May 2013.
- Related InfoLink provided by the sponsor.
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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.
Johnathan D McGinn, MD principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
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 Headache and Sinusitis, run by Penn State University 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 5 inclusion and 5 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 15 May 2013. 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.
What does the primary outcome measure?
Headache subtype (time frame: completion of questionnaire). It is what the study was designed to measure, not a finding.
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 15 May 2013.