NCT00934830

Antibiotics Versus Therapeutic Ultrasound for Sinusitis

Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Subjects (n=48) with clinically diagnosed acute bacterial rhinosinusitis (ABRS)will included. The antibiotic group will receive amoxicillin (500 mg) 3 times per day for 10 days. The ultrasound group will receive therapeutic ultrasound over sinuses at 1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days. Improvement of symptoms (pain and congestion; numeric rating scale; 0-10) from day 1 to days 4 and 21 will be recorded. Relapses, side-effects and satisfaction with treatment will be assessed at one-year follow-up.

Conditions

• Sinusitis

Interventions

Type	Name	Description
DRUG	Antibiotic (Amoxicillin)	500 mg, 3 times per day for 10 days
OTHER	Therapeutic ultrasound	1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.

Timeline

• Start date: 2005-01-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2009-07-08
• Last updated: 2013-10-29

Locations

1 site across 1 country: Norway