Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma (OMT)
Primary Purpose
Asthma
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
OMT + Usual Care
Usual Care
Sponsored by

About this trial
This is an interventional treatment trial for Asthma focused on measuring pediatrics, asthma, osteopathic manipulative treatment
Eligibility Criteria
Inclusion Criteria:
- children with asthma age between 5 and 14
Exclusion Criteria:
- associated co-morbities surgical patients
Sites / Locations
- Santo Spirito Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
OMT + Usual Care
Usual Care
Arm Description
Outcomes
Primary Outcome Measures
Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT
Secondary Outcome Measures
Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
Difference in percentage of hemoglobin saturation before and after OMT
Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT
Differences in the number, type and quality of somatic dysfunctions
Difference in peak expiratory flow (PEF) before and after OMT
Full Information
NCT ID
NCT01853189
First Posted
May 10, 2013
Last Updated
April 24, 2014
Sponsor
European Institute for Evidence Based Osteopathic Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01853189
Brief Title
Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma
Acronym
OMT
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Institute for Evidence Based Osteopathic Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
pediatrics, asthma, osteopathic manipulative treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OMT + Usual Care
Arm Type
Other
Arm Title
Usual Care
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
OMT + Usual Care
Intervention Description
patients from this group received 6 sessions of OMT
Intervention Type
Other
Intervention Name(s)
Usual Care
Intervention Description
patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
Time Frame
Participants will be assessed at entry, after 3 and 6 months.
Title
Difference in percentage of hemoglobin saturation before and after OMT
Time Frame
Participants will be assessed at entry, after 3 and 6 months.
Title
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.
Title
Differences in the number, type and quality of somatic dysfunctions
Time Frame
Participants will be assessed at entry, after 3 and 6 months
Title
Difference in peak expiratory flow (PEF) before and after OMT
Time Frame
Participants will be assessed at entry, after 3 and 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children with asthma age between 5 and 14
Exclusion Criteria:
associated co-morbities surgical patients
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cerritelli, MS, DO
Phone
+393394332801
Email
francesco.cerritelli@ebom.it
Facility Information:
Facility Name
Santo Spirito Hospital
City
Pescara
State/Province
Abruzzo
ZIP/Postal Code
65100
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Cerritelli, MS,DO
Phone
+393394332801
Email
francesco.cerritelli@ebom.it
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma
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