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Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

Primary Purpose

Otitis Media

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Craniosacral Osteopathic Manipulative Treatment
Botanicals
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media

Eligibility Criteria

12 Months - 60 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Written informed consent

Sites / Locations

  • University of Arizona

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
February 2, 2001
Last Updated
March 21, 2013
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00010465
Brief Title
Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children
Official Title
Osteopathic Manipulation and Echinacea for the Treatment of Recurrent Ear Infections in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
December 2002 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the efficacy of echinacea therapy and osteopathic manipulation for the prevention of further ear infections in children with recurrent ear infections (otitis media).
Detailed Description
Acute otitis media (inflammation of the middle ear) occurs in 60% of infants during the first year of life and in 85% by age 3. Approximately 17% of children suffer recurrent otitis media during the first year of life. Following acute otitis media, middle ear fluid effusions can persist for weeks to months. Approximately 40% of children with middle ear effusions have mild to moderate hearing loss for the duration of the effusion, and several studies have found evidence for impaired speech and language development among children with prolonged middle ear effusion. Since antibiotic use has become widespread, concern has emerged regarding antibiotic resistant S. pneumoniae strains and other bacteria. Children with recurrent otitis media commonly receive prophylactic antibiotic therapy or surgical insertion of tubes to prevent accumulation of middle ear effusion. The prevalence of pediatric use of complementary alternative medical (CAM) approaches for prevention of otitis media has not been widely quantified. This study will evaluate the use of osteopathic manipulation and echinacea therapy to prevent ear infection in children with recurrent otitis media.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Craniosacral Osteopathic Manipulative Treatment
Intervention Type
Drug
Intervention Name(s)
Botanicals

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
60 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Aldous
Organizational Affiliation
University of Arizona
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5073
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18831749
Citation
Wahl RA, Aldous MB, Worden KA, Grant KL. Echinacea purpurea and osteopathic manipulative treatment in children with recurrent otitis media: a randomized controlled trial. BMC Complement Altern Med. 2008 Oct 2;8:56. doi: 10.1186/1472-6882-8-56.
Results Reference
derived

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Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

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