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

Not Applicable

• Conditions: Prematurity
• Interventions: Other: usual care; Other: sham therapy; Other: osteopathic manipulative treatment

• Registration Number: NCT02146690
• Lead Sponsor: European Institute for Evidence Based Osteopathic Medicine

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 available

Study Timeline

• Study First Submitted: 2014-05-20
• Study First Submitted QC: 2014-05-21
• Study First Posted: 2014-05-26
• Study Start: 2014-06
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-15
• Last Update Posted: 2014-09-16
• Primary Completion: 2015-08
• Study Completion: 2015-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
baseline changes in pain score using Premature Infant Pain Profile	baseline and end of hospitalization, expected hospitalization 4 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pescara Civil Hospital; 🇮🇹 Pescara, Italy