Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma

Asthma Clinical Trial

— OMT  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01853189
• Other study ID #: OAsPed-1
• Status: Not yet recruiting
• Phase: N/A
• First received: May 10, 2013
• Last updated: April 24, 2014
• Start date: November 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2014
• Source: European Institute for Evidence Based Osteopathic Medicine
• Contact: Francesco Cerritelli, MS, DO
• Phone: +393394332801
• Email: francesco.cerritelli[@]ebom.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 14 Years

Eligibility

Inclusion Criteria:

• children with asthma age between 5 and 14

Exclusion Criteria:

• associated co-morbities surgical patients

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• OMT + Usual Care
patients from this group received 6 sessions of OMT
• Usual Care
patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group

Locations

Country	Name	City	State
Italy	Santo Spirito Hospital	Pescara	Abruzzo

Sponsors (1)

Lead Sponsor	Collaborator
European Institute for Evidence Based Osteopathic Medicine

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	Difference in fractional exhaled nitric oxide (FeNO) before and after OMT		Participants will be assessed at entry, after 3 and 6 months.	No
Secondary	Difference in percentage of hemoglobin saturation before and after OMT		Participants will be assessed at entry, after 3 and 6 months.	No
Secondary	Difference in Pediatric Asthma Quality of Life Questionnaire (PAQOL) before and after OMT		Participants will be assessed at entry, after 3 and 6 months.	No
Secondary	Differences in the number, type and quality of somatic dysfunctions		Participants will be assessed at entry, after 3 and 6 months	No
Secondary	Difference in peak expiratory flow (PEF) before and after OMT		Participants will be assessed at entry, after 3 and 6 months.	No