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

NCT ID: NCT00010465

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2002-12-31

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.

Conditions

Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Craniosacral Osteopathic Manipulative Treatment

Intervention Type: PROCEDURE

Botanicals

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 60 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: lead

Principal Investigators

Michael Aldous

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 18831749 (View on PubMed)

Other Identifiers

1P50AT000008-01

Identifier Type: NIH

Identifier Source: secondary_id

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P50AT000008-01P1

Identifier Type: NIH

Identifier Source: org_study_id

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NCT00009269

Identifier Type: -

Identifier Source: nct_alias