Effect of Osteopathic Manipulative Treatment on Reduction... | NCT02146690

Studies
Effect of Osteopathic Manipulative Treatment on Reduction of Pain in Complicated Newborns: RCT

NCT02146690

Sponsor

European Institute for Evidence Based Osteopathic Medicine

Status

Unknown status

Last Update Posted

Sep 16, 2014Estimated

Enrollment

225Estimated

Phase

Not Applicable

Conditions

Prematurity

Interventions

osteopathic manipulative treatment
sham therapy
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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2014

Primary Completion Date

Aug 2015Estimated

Completion Date

Nov 2015Estimated

First Submitted Date

May 20, 2014

First Submission Date that Met QC Criteria

May 21, 2014

First Posted Date

May 26, 2014Estimated

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

Sep 15, 2014

Last Update Posted Date

Sep 16, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The aim of the present 3 armed placebo control parallel group randomized control trial is to explore the extent to which osteopathic manipulative treatment is effective in reducing pain in a population of complicated newborns.

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

225Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
osteopathic manipulative treatment	Other	newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care	Other: osteopathic manipulative treatment Other: usual care
sham	Other	newborns will receive sham treatment for the entire period of hospitalization plus usual care	Other: sham therapy Other: usual care
usual care	Other	newborns allocated in the usual care arm will receive standard care only	Other: usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
osteopathic manipulative treatment	Other		osteopathic manipulative treatment
sham therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
baseline changes in pain score using Premature Infant Pain Profile		baseline and end of hospitalization, expected hospitalization 4 weeks

Secondary Outcomes

Measure	Description	Time Frame
Length of stay in days		participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Other Outcomes

Measure	Description	Time Frame
Neonatal Intensive Care Unit cost		participants will be followed for the duration of hospital stay, an expected average of 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

newborns born in the same hospital
either gender
diagnosis of any pathological/clinical medical condition

Exclusion Criteria:

lack of guardian consent
newborn transferred to/from other hospital
lack of any of the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

26 Weeks

Maximum Age

40 Weeks

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

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

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pescara Civil Hospital	Recruiting	Pescara		65121	Italy

Condition Browse Module

MeSH Terms

ID	Term
D047928	Premature Birth
D010146	Pain

Ancestor Terms

ID	Term
D007752	Obstetric Labor, Premature
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D026301	Manipulation, Osteopathic

Ancestor Terms

ID	Term
D026201	Musculoskeletal Manipulations
D000529	Complementary Therapies
D013812	Therapeutics
D026741	Physical Therapy Modalities

Browse Leaves

Not provided

Browse Branches

Not provided