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The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.

This study has been withdrawn prior to enrollment.
(Ethics Committee approval denied)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00547326
First Posted: October 22, 2007
Last Update Posted: April 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Ghent
  Purpose
Children with otitis media with effusion will be treated with osteopatic cranial techniques or with a placebo treatment. Before and after the treatment audiometric and tympanometric measures will take place. This procedure will be repeated 3 times, once a week and every session will last for 30-45 minutes. The fourth week, only audiometry and tympanomtry will be done.

Condition Intervention
Otitis Media With Effusion Procedure: treated with osteopatic cranial techniques Procedure: Treatment with placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Audiometric and tympanometric results [ Time Frame: directly after every session of treatment (3 times, once a week) ]

Secondary Outcome Measures:
  • Audiometric and tympanometric results [ Time Frame: one week after the last treatment session. ]

Estimated Enrollment: 60
Arms Assigned Interventions
Experimental: 1
Treatement with osteopatic cranial techniques
Procedure: treated with osteopatic cranial techniques
treated with osteopatic cranial techniques
Placebo Comparator: 2
Treatment with placebo
Procedure: Treatment with placebo
Treatment with placebo

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children between 3 and 7 years old
  • Bilateral otitis media with effusion
  • Tympanogram type B

Exclusion Criteria:

  • ventilation tubes
  • Damage of the tympanic membrane
  • Operation of the tympanic membrane
  • Other illness e.g. Down, craniofacial abnormalities,…
  Contacts and Locations
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): NCT00547326


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: I. Dhooge, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Responsible Party: Ingeborg Dhooge, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00547326     History of Changes
Other Study ID Numbers: 2007/397
First Submitted: October 19, 2007
First Posted: October 22, 2007
Last Update Posted: April 8, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases