Antibiotics Versus Therapeutic Ultrasound for Sinusitis

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00934830

Enrollment

Registered

2009-07-08

Start date

2005-01-31

Completion date

2008-10-31

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinusitis

Keywords

Antibiotic, Ultrasound, Efficacy, Treatment

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.

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.

Interventions

DRUGAntibiotic (Amoxicillin)

500 mg, 3 times per day for 10 days

OTHERTherapeutic ultrasound

1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* Subjects with any kind of antibiotic or allergic treatment within the last three weeks. * Antibiotic intolerance. * Pregnant women.

Design outcomes

Primary

Measure	Time frame
Pain and congestion over in forehead, around nose and pain in the teeth	Day 1, 4 and 21, and one-year follow-up

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 1, 2026