Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2020-02-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Nonsynostotic Plagiocephaly

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Infants were randomly assigned to two groups, OMT and LTT by using a random number generator, prepared in advance by an independent biostatistician. Sequentially numbered, opaque, and sealed envelopes were used.

Clinician-Investigators, neonatology staff, the physical therapist, and the osteopath in charge of assessment were unaware of the random list.

Infants' parents, after having signed the informed consent form, chose the numbered envelope and were unaware of the random list for the whole period of study.

The two osteopaths in charge of Osteopathic manipulative therapy and Light Touch Therapy were unblinded to group assignment.

Clinical outcomes were assessed by a biostatistician who was not involved in the patients' clinical allocation and management.

Study Groups

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Osteopathic manipulative therapy

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.

Group Type EXPERIMENTAL

Osteopathic manipulative therapy (OMTh)

Intervention Type OTHER

The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.

Repositioning therapy

Intervention Type OTHER

It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.

Light Touch Therapy

Repositioning Therapy plus Light Touch Therapy (LTT)

Participants to the LTT group receive the LTT protocol at the same date of the OMTh group.

Group Type SHAM_COMPARATOR

Light Touch Therapy (LTT)

Intervention Type OTHER

The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.

Repositioning therapy

Intervention Type OTHER

It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.

Interventions

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Osteopathic manipulative therapy (OMTh)

The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.

Intervention Type OTHER

Light Touch Therapy (LTT)

The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.

Intervention Type OTHER

Repositioning therapy

It consists of strategies that guide the parents to position the baby "back to sleep", by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No