Study Results
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View full resultsBasic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2018-11-29
2019-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Active
ClearUP Sinus Pain Relief
Microcurrent Device Treatment
Interventions
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ClearUP Sinus Pain Relief
Microcurrent Device Treatment
Eligibility Criteria
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Inclusion Criteria
* Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
* Current pain score ≥ 5 (Numeric Rating Scale 0-10)
* Frequency of sinus/facial pain at least twice weekly for 1 month
* Able to read and understand English
* Agree to participate in the study
* Able and willing to provide Informed Consent
* Currently taking or recently taken any oral steroid medications in the last 90 days
* Sinus surgery in previous 90 days
* History of Chronic Migraine (≥ 15 headache days per month)
* Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
* Purulent rhinorrhea
18 Years
71 Years
ALL
No
Sponsors
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Tivic Health Systems
INDUSTRY
Responsible Party
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Locations
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Allergy and Asthma Associates of Santa Clara Valley Research Center
San Jose, California, United States
Countries
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References
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Goldsobel AB, Prabhakar N, Gurfein BT. Prospective trial examining safety and efficacy of microcurrent stimulation for the treatment of sinus pain and congestion. Bioelectron Med. 2019 Nov 20;5:18. doi: 10.1186/s42234-019-0035-x. eCollection 2019.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP00003
Identifier Type: -
Identifier Source: org_study_id
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