Antibiotics Versus Therapeutic Ultrasound for Sinusitis

NCT ID: NCT00934830

Last Updated: 2013-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-10-31

Brief Summary

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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

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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

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Sinusitis

Keywords

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Antibiotic Ultrasound Efficacy Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antibiotic

Group Type ACTIVE_COMPARATOR

Antibiotic (Amoxicillin)

Intervention Type DRUG

500 mg, 3 times per day for 10 days

Therapeutic ultrasound

Group Type EXPERIMENTAL

Therapeutic ultrasound

Intervention Type OTHER

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

Interventions

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Antibiotic (Amoxicillin)

500 mg, 3 times per day for 10 days

Intervention Type DRUG

Therapeutic ultrasound

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sør-Trøndelag chapter of the Norwegian Physiotherapist Association

UNKNOWN

Sponsor Role collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ottar Vasseljen, PhD

Role: STUDY_CHAIR

Norwegian University of Science and Technology

Locations

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Røros Medical Center

Røros, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type RESULT
PMID: 20500134 (View on PubMed)

Other Identifiers

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ELI-107-04(REK)

Identifier Type: -

Identifier Source: org_study_id