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Completed

NCT Number: NCT00934830

Antibiotics Versus Therapeutic Ultrasound for Sinusitis

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.

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Key information

Conditions

Sinusitis Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Røros Medical Center

Røros, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antibiotic (Amoxicillin)

Drug

500 mg, 3 times per day for 10 days

therapeutic ultrasound

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • Sør-Trøndelag chapter of the Norwegian Physiotherapist Association

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Jul 8, 2009
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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