Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

PRIOLO CLAUDIO

Status: Completed

Conditions: Nonsynostotic Plagiocephaly

Treatments: Other: Repositioning therapy; Other: Light Touch Therapy (LTT); Other: Osteopathic manipulative therapy (OMTh)

Study type: Interventional

Funder types: Other

Identifiers

NCT03970395

0074260

Details and patient eligibility

About

The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.

Full description

Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.

Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.

Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.

In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.

Enrollment: 96 patients

Sex: All

Ages: 1 to 6 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with NSP, ODDI score of 104% or more.
• To be at term corrected age if born prematurely.

Exclusion criteria

• Synostotic Plagiocephaly
• Infant who underwent an osteopathic manipulative treatment before the enrolment
• Dysmorphisms
• Syndromes
• Congenital Muscular Torcicolis
• Cerebral Palsy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups

Osteopathic manipulative therapy

Experimental group

Description:

Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). Osteopathic Manipulative Therapy. Participant OMT group receive 6 OMTh in 3 months, as follows: first at baseline, the second after 1 week, the third after 3 weeks, and then once every 3 weeks for three more visits.

Treatment:

Other: Repositioning therapy

Other: Osteopathic manipulative therapy (OMTh)

Light Touch Therapy

Sham Comparator group

Description:

Repositioning Therapy plus Light Touch Therapy (LTT) Participants to the LTT group receive the LTT protocol at the same date of the OMTh group.

Treatment:

Other: Repositioning therapy

Other: Light Touch Therapy (LTT)