Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma

Not Applicable

• Conditions: Asthma
• Interventions: Other: OMT + Usual Care; Other: Usual Care

• Registration Number: NCT01853189
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-13
• Study First Posted: 2013-05-14
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25
• Study Start: 2014-11
• Primary Completion: 2015-09
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• children with asthma age between 5 and 14

Exclusion Criteria

• associated co-morbities surgical patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OMT + Usual Care	OMT + Usual Care	-
Usual Care	Usual Care	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Santo Spirito Hospital; 🇮🇹 Pescara, Abruzzo, Italy