Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma (OMT)

April 24, 2014 updated by: European Institute for Evidence Based Osteopathic Medicine

Asthma is a highly prevalent chronic disease in children. Complementary and Alternative Medicine research on asthma showed a potential effect on pediatric patients.

Studies looking at the effect of Osteopathic Manipulative Treatment seems to reveal positive results.

The aim of study is to further explore the role of OMT on asthma in a pediatric population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Abruzzo
      • Pescara, Abruzzo, Italy, 65100
        • Santo Spirito Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children with asthma age between 5 and 14

Exclusion Criteria:

  • associated co-morbities surgical patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Usual Care
Other: Usual Care
patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group
Other: OMT + Usual Care
Other: OMT + Usual Care
patients from this group received 6 sessions of OMT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT
Time Frame: Participants will be assessed at entry, after 3 and 6 months.
Participants will be assessed at entry, after 3 and 6 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
Time Frame: Participants will be assessed at entry, after 3 and 6 months.
Participants will be assessed at entry, after 3 and 6 months.
Difference in percentage of hemoglobin saturation before and after OMT
Time Frame: Participants will be assessed at entry, after 3 and 6 months.
Participants will be assessed at entry, after 3 and 6 months.
Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT
Time Frame: Participants will be assessed at entry, after 3 and 6 months.
Participants will be assessed at entry, after 3 and 6 months.
Differences in the number, type and quality of somatic dysfunctions
Time Frame: Participants will be assessed at entry, after 3 and 6 months
Participants will be assessed at entry, after 3 and 6 months
Difference in peak expiratory flow (PEF) before and after OMT
Time Frame: Participants will be assessed at entry, after 3 and 6 months.
Participants will be assessed at entry, after 3 and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Anticipated)

September 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 10, 2013

First Submitted That Met QC Criteria

May 13, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

April 25, 2014

Last Update Submitted That Met QC Criteria

April 24, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OAsPed-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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