Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

NCT03970395 | Completed Results DMC

• 1 other identifier: 0074260
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nonsynostotic Plagiocephaly

Keywords

Positional Plagiocephaly, Deformational Plagiocephaly,

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• Cranial Proportion Index (CPI)

  The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.

• Adverse Event

  From first treatment (1 week post-baseline) up to end of treatment course (3 months).

Study Arms (2)

Osteopathic manipulative therapy

EXPERIMENTAL

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); Other: Repositioning therapy

Light Touch Therapy

SHAM COMPARATOR

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: Light Touch Therapy (LTT); Other: Repositioning therapy

Interventions

Osteopathic manipulative therapy (OMTh) 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.

Osteopathic manipulative therapy

Light Touch Therapy (LTT) 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.

Light Touch Therapy

Repositioning therapy 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; Osteopathic manipulative therapy

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• PRIOLO CLAUDIO: lead
• Scuola Superiore di Osteopatia Italiana: collaborator

Study Sites (1)

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

Torino, 10126, Italy

Location

Related Publications (6)

• 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.

  PMID: 21187783 BACKGROUND

• 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.

  PMID: 21187782 BACKGROUND

• 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.

  PMID: 21726785 BACKGROUND

• 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.

  PMID: 21982132 BACKGROUND

• 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.

  PMID: 16211401 BACKGROUND

• Bagagiolo D, Priolo CG, Favre EM, Pangallo A, Didio A, Sbarbaro M, Borro T, Dacco S, Manzoni P, Farina D. A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with Nonsynostotic Plagiocephaly. Am J Perinatol. 2022 Dec;39(S 01):S52-S62. doi: 10.1055/s-0042-1758723. Epub 2022 Nov 30.

  PMID: 36451623 DERIVED

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Plagiocephaly; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Dr Claudio G Priolo
• Organization: Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy

claudiog.priolo@gmail.com

0039 3471403064

Study Officials

• Claudio G Priolo, Medical

  Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy

  STUDY DIRECTOR

• Daniele Farina, Medical

  Azienda Ospedaliera Città della Salute e della scienza di Torino _ Italy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Paediatrician

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

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 31, 2019
• Study Start: September 1, 2016
• Primary Completion: February 26, 2020
• Study Completion: February 26, 2020
• Last Updated: February 12, 2021
• Results First Posted: September 24, 2020

Record last verified: 2021-02

Locations

IT (1)