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

NCT ID: NCT02146690

Last Updated: 2014-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-11-30

Brief Summary

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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

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Conditions

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Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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osteopathic manipulative treatment

newborns will receive osteopathic manipulative evaluation and treatment during the entire period of hospitalization plus usual care

Group Type OTHER

osteopathic manipulative treatment

Intervention Type OTHER

usual care

Intervention Type OTHER

sham

newborns will receive sham treatment for the entire period of hospitalization plus usual care

Group Type OTHER

sham therapy

Intervention Type OTHER

usual care

Intervention Type OTHER

usual care

newborns allocated in the usual care arm will receive standard care only

Group Type OTHER

usual care

Intervention Type OTHER

Interventions

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osteopathic manipulative treatment

Intervention Type OTHER

sham therapy

Intervention Type OTHER

usual care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

26 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute for Evidence Based Osteopathic Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pescara Civil Hospital

Pescara, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Francesco Cerritelli

Role: CONTACT

+393394332801

Facility Contacts

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Francesco Cerritelli

Role: primary

+393394332801

Other Identifiers

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NEO-Pa 2

Identifier Type: -

Identifier Source: org_study_id

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