Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Nonsynostotic Plagiocephaly Clinical Trial

Official title:

Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970395
• Other study ID #: 0074260
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: February 26, 2020

Study information

• Verified date: February 2021
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: February 26, 2020
• Est. primary completion date: February 26, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 6 Months

Eligibility

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

Related Conditions & MeSH terms

• Nonsynostotic Plagiocephaly
• Plagiocephaly
• Plagiocephaly, Nonsynostotic

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Italy	Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.	Torino

Sponsors (2)

Lead Sponsor	Collaborator
PRIOLO CLAUDIO	Scuola Superiore di Osteopatia Italiana

Country where clinical trial is conducted

Italy, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Epub 2005 Oct 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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.
Secondary	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).