Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma
OMT
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable asthma
Started Nov 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedStudy Start
First participant enrolled
November 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 25, 2014
April 1, 2014
10 months
May 10, 2013
April 24, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Forced expiratory volume in the 1st second (FEV1) before and after OMT
Participants will be assessed at entry, after 3 and 6 months.
Secondary Outcomes (5)
Difference in fractional exhaled nitric oxide (FeNO) before and after OMT
Participants will be assessed at entry, after 3 and 6 months.
Difference in percentage of hemoglobin saturation before and after OMT
Participants will be assessed at entry, after 3 and 6 months.
Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT
Participants will be assessed at entry, after 3 and 6 months.
Differences in the number, type and quality of somatic dysfunctions
Participants will be assessed at entry, after 3 and 6 months
Difference in peak expiratory flow (PEF) before and after OMT
Participants will be assessed at entry, after 3 and 6 months.
Study Arms (2)
OMT + Usual Care
OTHERUsual Care
OTHERInterventions
patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group
Eligibility Criteria
You may qualify if:
- children with asthma age between 5 and 14
You may not qualify if:
- associated co-morbities surgical patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Santo Spirito Hospital
Pescara, Abruzzo, 65100, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 10, 2013
First Posted
May 14, 2013
Study Start
November 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2015
Last Updated
April 25, 2014
Record last verified: 2014-04