Antibiotics Versus Therapeutic Ultrasound for Sinusitis

Sinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00934830
• Other study ID #: ELI-107-04(REK)
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2009
• Last updated: October 28, 2013
• Start date: January 2005
• Est. completion date: October 2008

Study information

• Verified date: October 2013
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sinusitis

Intervention

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.

Locations

Country	Name	City	State
Norway	Røros Medical Center	Røros

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	Sør-Trøndelag chapter of the Norwegian Physiotherapist Association

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Høsøien 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and congestion over in forehead, around nose and pain in the teeth		Day 1, 4 and 21, and one-year follow-up	No