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Antibiotics Versus Therapeutic Ultrasound for Sinusitis

This study has been completed.
Sponsor:
Collaborator:
Sør-Trøndelag chapter of the Norwegian Physiotherapist Association
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00934830
First received: July 6, 2009
Last updated: October 28, 2013
Last verified: October 2013
  Purpose
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 Intervention Phase
Sinusitis
Drug: Antibiotic (Amoxicillin)
Other: Therapeutic ultrasound
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antibiotics Versus Therapeutic Ultrasound for Treatment of Sinusitis: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: January 2005
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00934830     History of Changes
Other Study ID Numbers: ELI-107-04(REK)
Study First Received: July 6, 2009
Last Updated: October 28, 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

ClinicalTrials.gov processed this record on May 23, 2017