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Antibiotics Versus Therapeutic Ultrasound for Sinusitis

Primary Purpose

Sinusitis

Status
Completed
Phase
Phase 3
Locations
Norway
Study Type
Interventional
Intervention
Antibiotic (Amoxicillin)
Therapeutic ultrasound
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sinusitis focused on measuring Antibiotic, Ultrasound, Efficacy, Treatment

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Røros Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Antibiotic

Therapeutic ultrasound

Arm Description

Outcomes

Primary Outcome Measures

Pain and congestion over in forehead, around nose and pain in the teeth

Secondary Outcome Measures

Full Information

First Posted
July 6, 2009
Last Updated
October 28, 2013
Sponsor
Norwegian University of Science and Technology
Collaborators
Sør-Trøndelag chapter of the Norwegian Physiotherapist Association
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1. Study Identification

Unique Protocol Identification Number
NCT00934830
Brief Title
Antibiotics Versus Therapeutic Ultrasound for Sinusitis
Official Title
Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Sør-Trøndelag chapter of the Norwegian Physiotherapist Association

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
Keywords
Antibiotic, Ultrasound, Efficacy, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Antibiotic
Arm Type
Active Comparator
Arm Title
Therapeutic ultrasound
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Antibiotic (Amoxicillin)
Intervention Description
500 mg, 3 times per day for 10 days
Intervention Type
Other
Intervention Name(s)
Therapeutic ultrasound
Intervention Description
1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.
Primary Outcome Measure Information:
Title
Pain and congestion over in forehead, around nose and pain in the teeth
Time Frame
Day 1, 4 and 21, and one-year follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ottar Vasseljen, PhD
Organizational Affiliation
Norwegian University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Røros Medical Center
City
Røros
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20500134
Citation
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.
Results Reference
result

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Antibiotics Versus Therapeutic Ultrasound for Sinusitis

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