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Antibiotics Versus Therapeutic Ultrasound for Sinusitis

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ClinicalTrials.gov Identifier: NCT00934830
Recruitment Status : Completed
First Posted : July 8, 2009
Last Update Posted : October 29, 2013
Sponsor:
Collaborator:
Sør-Trøndelag chapter of the Norwegian Physiotherapist Association
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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.

Condition or disease Intervention/treatment Phase
Sinusitis Drug: Antibiotic (Amoxicillin) Other: Therapeutic ultrasound Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial
Study Start Date : January 2005
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Antibiotic Drug: Antibiotic (Amoxicillin)
500 mg, 3 times per day for 10 days

Experimental: Therapeutic ultrasound Other: Therapeutic ultrasound
1.0 W/cm2 in continuous mode for 10 minutes once a day for 4 consecutive days.




Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00934830


Locations
Norway
Røros Medical Center
Røros, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Sør-Trøndelag chapter of the Norwegian Physiotherapist Association
Investigators
Study Chair: Ottar Vasseljen, PhD Norwegian University of Science and Technology

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00934830     History of Changes
Other Study ID Numbers: ELI-107-04(REK)
First Posted: July 8, 2009    Key Record Dates
Last Update Posted: October 29, 2013
Last Verified: October 2013

Keywords provided by Norwegian University of Science and Technology:
Antibiotic
Ultrasound
Efficacy
Treatment

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Amoxicillin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents