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

European Institute for Evidence Based Osteopathic Medicine

Status: Unknown

Conditions: Prematurity

Treatments: Other: sham therapy; Other: osteopathic manipulative treatment; Other: usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT02146690

NEO-Pa 2

Details and patient eligibility

About

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.

Enrollment: 225 estimated patients

Sex: All

Ages: 26 to 40 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

osteopathic manipulative treatment

Other group

Description:

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

Treatment:

Other: usual care

Other: osteopathic manipulative treatment

sham

Other group

Description:

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

Treatment:

Other: usual care

Other: sham therapy

usual care

Other group

Description:

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

Treatment:

Other: usual care