Antibiotics Versus Therapeutic Ultrasound for Sinusitis

Norwegian University of Science and Technology

Status and phase

Completed

Phase 3

Conditions

Sinusitis

Treatments

Other: Therapeutic ultrasound

Drug: Antibiotic (Amoxicillin)

Study type

Interventional

Funder types

Other

Identifiers

NCT00934830

ELI-107-04(REK)

Details and patient eligibility

About

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.

Full 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.

Enrollment

48 patients

Sex

All

Ages

15+ years old

Volunteers

No 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