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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This study has been withdrawn prior to enrollment.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
October 19, 2007
October 22, 2007
April 8, 2008
Not Provided
Not Provided
Audiometric and tympanometric results [ Time Frame: directly after every session of treatment (3 times, once a week) ]
Same as current
Complete list of historical versions of study NCT00547326 on ClinicalTrials.gov Archive Site
Audiometric and tympanometric results [ Time Frame: one week after the last treatment session. ]
Same as current
Not Provided
Not Provided
 
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
The Effect of Osteopatic Cranial Techniques on the Audiometric and Tympanometric Values in Children Suffering From Otitis Media With Effusion.
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Otitis Media With Effusion
  • Procedure: treated with osteopatic cranial techniques
    treated with osteopatic cranial techniques
  • Procedure: Treatment with placebo
    Treatment with placebo
  • Experimental: 1
    Treatement with osteopatic cranial techniques
    Intervention: Procedure: treated with osteopatic cranial techniques
  • Placebo Comparator: 2
    Treatment with placebo
    Intervention: Procedure: Treatment with placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
60
Not Provided
Not Provided

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,…
Sexes Eligible for Study: All
3 Years to 7 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT00547326
2007/397
No
Not Provided
Not Provided
Ingeborg Dhooge, MD, PhD, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: I. Dhooge, MD, PhD University Hospital, Ghent
University Hospital, Ghent
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP