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Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma (OMT)

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ClinicalTrials.gov Identifier: NCT01853189
Recruitment Status : Unknown
Verified April 2014 by European Institute for Evidence Based Osteopathic Medicine.
Recruitment status was:  Not yet recruiting
First Posted : May 14, 2013
Last Update Posted : April 25, 2014
Sponsor:
Information provided by (Responsible Party):
European Institute for Evidence Based Osteopathic Medicine

Study Description
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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.


Condition or disease Intervention/treatment Phase
Asthma Other: OMT + Usual Care Other: Usual Care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2014
Estimated Primary Completion Date : September 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Difference in fractional exhaled nitric oxide (FeNO) before and after OMT [ Time Frame: Participants will be assessed at entry, after 3 and 6 months. ]
  2. Difference in percentage of hemoglobin saturation before and after OMT [ Time Frame: Participants will be assessed at entry, after 3 and 6 months. ]
  3. 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. ]
  4. Differences in the number, type and quality of somatic dysfunctions [ Time Frame: Participants will be assessed at entry, after 3 and 6 months ]
  5. Difference in peak expiratory flow (PEF) before and after OMT [ Time Frame: Participants will be assessed at entry, after 3 and 6 months. ]

Eligibility Criteria
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Ages Eligible for Study:   5 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children with asthma age between 5 and 14

Exclusion Criteria:

  • associated co-morbities surgical patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01853189


Contacts
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Contact: Francesco Cerritelli, MS, DO +393394332801 francesco.cerritelli@ebom.it

Locations
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Italy
Santo Spirito Hospital
Pescara, Abruzzo, Italy, 65100
Contact: Francesco Cerritelli, MS,DO    +393394332801    francesco.cerritelli@ebom.it   
Sponsors and Collaborators
European Institute for Evidence Based Osteopathic Medicine
More Information
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Responsible Party: European Institute for Evidence Based Osteopathic Medicine
ClinicalTrials.gov Identifier: NCT01853189    
Other Study ID Numbers: OAsPed-1
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Keywords provided by European Institute for Evidence Based Osteopathic Medicine:
pediatrics
asthma
osteopathic manipulative treatment
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases