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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)

Interventions

  • Procedure: treated with osteopatic cranial techniques
    • treated with osteopatic cranial techniques
  • Procedure: Treatment with placebo
    • Treatment with placebo

Arms, Groups and Cohorts

  • Experimental: 1
    • Treatement with osteopatic cranial techniques
  • Placebo Comparator: 2
    • Treatment with placebo

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Audiometric and tympanometric results
    • Time Frame: one week after the last treatment session.

Participating in This Clinical Trial

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,…

Gender Eligibility: All

Minimum Age: 3 Years

Maximum Age: 7 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Ghent
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • I. Dhooge, MD, PhD, Principal Investigator, University Hospital, Ghent

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