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This study has been withdrawn prior to enrollment.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:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00547326
First received: October 19, 2007
Last updated: April 7, 2008
Last verified: April 2008
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: Ingeborg Dhooge, MD, PhD, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00547326     History of Changes
Other Study ID Numbers: 2007/397
Study First Received: October 19, 2007
Last Updated: April 7, 2008
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 18, 2014