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Behavioural Intervention
SinuSonic for Sinus Headache
N/A
Recruiting
Led By Amar Miglani, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Facial pain or pressure for > 3 months of symptom duration.
Pain/pressure VAS score of > 5.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
Study Summary
This trial is testing a new device to see if it can relieve facial pain and pressure better than a placebo device.
Eligible Conditions
- Facial Pain
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have had constant facial pain or pressure for more than 3 months.
Select...
You are experiencing significant pain or pressure, rated higher than 5 on a scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brief Pain Inventory Short Form
Change in facial pain
Secondary outcome measures
Change in nasal obstruction symptoms
Subjects reporting epistaxis
Subjects reporting pain with device use
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SinuSonic GroupExperimental Treatment1 Intervention
Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks
Group II: Sham GroupPlacebo Group1 Intervention
Subjects will use the sham device for 2 minutes twice daily for 8 weeks
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,176 Previous Clinical Trials
3,757,952 Total Patients Enrolled
1 Trials studying Facial Pain
300 Patients Enrolled for Facial Pain
Amar Miglani, MDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a cold or similar illness in the past 2 weeks.You are allergic to silicone or any part of the device.You have used nasal decongestant spray in the past week.You have crusts or sores in your nose.You have had constant facial pain or pressure for more than 3 months.You have signs of sinus problems during a medical exam, such as nasal polyps or sinus inflammation.You are experiencing significant pain or pressure, rated higher than 5 on a scale.You have a history of severe nosebleeds.You have sinusitis shown on imaging tests.
Research Study Groups:
This trial has the following groups:- Group 1: SinuSonic Group
- Group 2: Sham Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any available positions for patients in this trial?
"According to the website, this trial is no longer actively recruiting patients. The original posting date was December 1st, 2022 and the most recent update was on October 26th of the same year. There are 168 other trials that you might consider enrolling in."
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