Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

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.

Study Overview

• Status: Completed
• Conditions: Nonsynostotic Plagiocephaly
• Intervention / Treatment: Other: Osteopathic manipulative therapy (OMTh); Other: Repositioning therapy; Other: Light Touch Therapy (LTT)

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Torino, Italy, 10126
    • Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 10 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.; 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.
Sham Comparator: 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.	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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months	The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.	Baseline and 3 months
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.	The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.	Follow-up at 1 year of age
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months	The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104 Nonsynostotic Plagiocephaly ODDI score <104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.	At 3 months
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.	The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of Nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score >=104<108 MILD Nonsynostotic Plagiocephaly ODDI score >=108<112 MODERATE Nonsynostotic Plagiocephaly ODDI score >= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome.	Follow-up at one year of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cranial Proportion Index (CPI)	Change of the width and length diameter measured with Plagiocephalometry.	The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.
Adverse Event	Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy	From first treatment (1 week post-baseline) up to end of treatment course (3 months).

Collaborators and Investigators

• Sponsor: PRIOLO CLAUDIO
• Collaborators: Scuola Superiore di Osteopatia Italiana
• Investigators: Study Director: Claudio G Priolo, Medical, Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy; Principal Investigator: Daniele Farina, Medical, Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy

Publications and helpful links

General Publications

• van Vlimmeren LA, Takken T, van Adrichem LN, van der Graaf Y, Helders PJ, Engelbert RH. Plagiocephalometry: a non-invasive method to quantify asymmetry of the skull; a reliability study. Eur J Pediatr. 2006 Mar;165(3):149-57. doi: 10.1007/s00431-005-0011-1. Epub 2005 Oct 7.
• Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part I: terminology, diagnosis, and etiopathogenesis. J Craniofac Surg. 2011 Jan;22(1):9-16. doi: 10.1097/SCS.0b013e3181f6c313.
• Rogers GF. Deformational plagiocephaly, brachycephaly, and scaphocephaly. Part II: prevention and treatment. J Craniofac Surg. 2011 Jan;22(1):17-23. doi: 10.1097/SCS.0b013e3181f6c342.
• Lennartsson F. Developing guidelines for child health care nurses to prevent nonsynostotic plagiocephaly: searching for the evidence. J Pediatr Nurs. 2011 Aug;26(4):348-58. doi: 10.1016/j.pedn.2010.07.003. Epub 2010 Sep 25.
• Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants. Complement Ther Clin Pract. 2011 Nov;17(4):193-8. doi: 10.1016/j.ctcp.2011.02.001. Epub 2011 Mar 5.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): February 26, 2020
• Study Completion (Actual): February 26, 2020

Study Registration Dates

• First Submitted: May 5, 2019
• First Submitted That Met QC Criteria: May 30, 2019
• First Posted (Actual): May 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Positional Plagiocephaly, Deformational Plagiocephaly,
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Plagiocephaly; Plagiocephaly, Nonsynostotic
• Other Study ID Numbers: 0074260

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No