Antibiotics Versus Therapeutic Ultrasound for Sinusitis
1 other identifier
interventional
48
1 country
1
Brief Summary
Question: Is the effect of therapeutic ultrasound equally effective to antibiotic for treatment of sinusitis? Design: A randomized clinical trial with concealed allocation, self-assessment by the subjects and intention-to-treat analysis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2005
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedOctober 29, 2013
October 1, 2013
3.8 years
July 6, 2009
October 28, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain and congestion over in forehead, around nose and pain in the teeth
Day 1, 4 and 21, and one-year follow-up
Study Arms (2)
Antibiotic
ACTIVE COMPARATORTherapeutic ultrasound
EXPERIMENTALInterventions
1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.
Eligibility Criteria
You may qualify if:
- Pain when bending forward, headache, pain in the teeth, purulent nasal secretion, "double worsening" and white blood cell count (WBC).
- Patients eligible for the study had to meet one of the first three criteria (pain when bending forward, headache, pain in the teeth) and all of the other indicators (purulent nasal secretion, double worsening, a left handed displacement of lymphocytes and a right handed displacement of granulocytes on the WBC as indication of bacterial infection).
- Subjects over 15 years of age were included.
You may not qualify if:
- Subjects with any kind of antibiotic or allergic treatment within the last three weeks.
- Antibiotic intolerance.
- Pregnant women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Røros Medical Center
Røros, Norway
Related Publications (1)
Hosoien E, Lund AB, Vasseljen O. Similar effect of therapeutic ultrasound and antibiotics for acute bacterial rhinosinusitis: a randomised trial. J Physiother. 2010;56(1):29-32.
PMID: 20500134RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Ottar Vasseljen, PhD
Norwegian University of Science and Technology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 8, 2009
Study Start
January 1, 2005
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
October 29, 2013
Record last verified: 2013-10