Effectiveness of Osteopathic Manipulative Treatment in Pe... | NCT01853189

Studies
Effectiveness of Osteopathic Manipulative Treatment in Pediatric Asthma

NCT01853189

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Status

Unknown status

Last Update Posted

Apr 25, 2014Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Asthma

Interventions

OMT + Usual Care
Usual Care

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2014

Primary Completion Date

Sep 2015Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

May 13, 2013

First Posted Date

May 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2014

Last Update Posted Date

Apr 25, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OMT + Usual Care	Other		Other: OMT + Usual Care
Usual Care	Other		Other: Usual Care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OMT + Usual Care	Other	patients from this group received 6 sessions of OMT	OMT + Usual Care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children with asthma age between 5 and 14

Exclusion Criteria:

associated co-morbities surgical patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Years

Maximum Age

14 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Francesco Cerritelli, MS, DO	Contact	+393394332801		francesco.cerritelli@ebom.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santo Spirito Hospital		Pescara	Abruzzo	65100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D001249	Asthma

Ancestor Terms

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided