Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

• Sponsor: PRIOLO CLAUDIO (Other)
• Overall Status: Completed
• CT.gov ID: NCT03970395
• Collaborator: Scuola Superiore di Osteopatia Italiana (Other)
• Enrollment: 96
• Location: 1
• Arms: 2
• Actual Duration (Months): 41.8
• Patients Per Site Per Month: 2.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nonsynostotic Plagiocephaly	Other: Osteopathic manipulative therapy (OMTh); Other: Light Touch Therapy (LTT); Other: Repositioning therapy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 96 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch TherapyA two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Feb 26, 2020
• Actual Study Completion Date: Feb 26, 2020

Arms and Interventions

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: 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.; 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months [Baseline and 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.

2. Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. [Follow-up 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.

3. Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months [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.

4. Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. [Follow-up at one 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.

Secondary Outcome Measures

1. 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.]

   Change of the width and length diameter measured with Plagiocephalometry.

2. Adverse Event [From first treatment (1 week post-baseline) up to end of treatment course (3 months).]

   Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 6 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Universitaria Città della Salute e della Scienza.	Torino		Italy	10126

Sponsors and Collaborators

• PRIOLO CLAUDIO
• 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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 19, 2019

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: PRIOLO CLAUDIO, Paediatrician, Azienda Ospedaliera Città della Salute e della Scienza di Torino
• ClinicalTrials.gov Identifier: NCT03970395
• Other Study ID Numbers: 0074260
• First Posted: May 31, 2019
• Last Update Posted: Feb 12, 2021
• Last Verified: Feb 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by PRIOLO CLAUDIO, Paediatrician, Azienda Ospedaliera Città della Salute e della Scienza di Torino: Positional Plagiocephaly, Deformational Plagiocephaly,
• Additional relevant MeSH terms: Plagiocephaly; Plagiocephaly, Nonsynostotic

Study Results

Participant Flow

Recruitment Details	Of the 129 infants screened at Sant'Anna Hospital, 96 were enrolled between September 2016 and June 2019.

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopath with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopath with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".
Period Title: Overall Study
STARTED	48	48
COMPLETED	41	36
NOT COMPLETED	7	12

Baseline Characteristics

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy	Total
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI )score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, Oblique Diameter Difference Index (ODDI) score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Total of all reporting groups
Overall Participants	48	48	96
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	3.1 (1.4)	3.2 (1.6)	3.1 (1.5)
Sex: Female, Male (Count of Participants)
Female	21 43.8%	22 45.8%	43 44.8%
Male	27 56.3%	26 54.2%	53 55.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	48 100%	48 100%	96 100%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Italy	48 100%	48 100%	96 100%
Gestational Age (weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [weeks]	36.7 (3.9)	34.3 (4.6)	35.5 (4.2)
Presentation at birth (Count of Participants)
Cefalic	39 81.3%	37 77.1%	76 79.2%
Breech	2 4.2%	6 12.5%	8 8.3%
Trasvers	7 14.6%	5 10.4%	12 12.5%
Birth weight (grams) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [grams]	2657 (945)	2290 (995)	2473 (970)
Mother's first pregnancy (Count of Participants)
Count of Participants [Participants]	24 50%	26 54.2%	50 52.1%
Multiple birth (Count of Participants)
Count of Participants [Participants]	6 12.5%	10 20.8%	16 16.7%
Delivery (Count of Participants)
Vaginal	14 29.2%	11 22.9%	25 26%
Assisted	9 18.8%	6 12.5%	15 15.6%
Vacuum - Forceps	4 8.3%	4 8.3%	8 8.3%
Cesarean	21 43.8%	27 56.3%	48 50%
Feeding (Count of Participants)
Maternal	14 29.2%	12 25%	26 27.1%
Bottle	22 45.8%	26 54.2%	48 50%
Mix	12 25%	10 20.8%	22 22.9%
Sleeping (Count of Participants)
Supine	46 95.8%	48 100%	94 97.9%
Variable	2 4.2%	0 0%	2 2.1%
Daytime (Count of Participants)
Supine	35 72.9%	34 70.8%	69 71.9%
Variable	13 27.1%	14 29.2%	27 28.1%
Mother's age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.8 (5.4)	35.1 (6.5)	34.45 (5.95)
Father's age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	36.9 (6.8)	37.1 (6.8)	37 (6.8)
Age end of study (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	6.1 (1.4)	6.2 (1.6)	6.15 (1.15)

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
Description	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.
Time Frame	Baseline and 3 months

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy. OMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.	Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.
Measure Participants	48	48
ODDI score <104%	23 47.9%	3 6.3%
ODDI score >=104%	25 52.1%	45 93.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Osteopathic Manipulative Therapy Plus Repositioning Therapy, Light Touch Therapy Plus Repositioning Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments	The threshold for statistical significance was p<0.5
	Method	Risk Ratio (RR)
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	7.66
	Confidence Interval	(2-Sided) 95%; 2.46 to 23.84
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk Difference 0.41 (IC 95; 0.25-0.53)

2. Primary Outcome

Title	Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
Description	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.
Time Frame	Follow-up at 1 year of age

Outcome Measure Data

Analysis Population Description

Intent to Treat Population (all infants assigned to OMTh or LTT). Last observation carried forward (LOCF) imputation method.

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".
Measure Participants	48	48
ODDI score <104%	28 58.3%	5 10.4%
ODDI score >=104%	20 41.7%	43 89.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Osteopathic Manipulative Therapy Plus Repositioning Therapy, Light Touch Therapy Plus Repositioning Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Relative Risk (RR)
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	5.6
	Confidence Interval	(2-Sided) 95%; 2.36 to 13.27
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk Difference 0.47 (IC 95; 0.31-0.64)

3. Primary Outcome

Title	Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
Description	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.
Time Frame	At 3 months

Outcome Measure Data

Analysis Population Description

Per Protocol population, defined as participants completing the three months intervention.

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".
Measure Participants	45	44
ODDI score <104%	23 47.9%	3 6.3%
ODDI score >=104%	22 45.8%	41 85.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Osteopathic Manipulative Therapy Plus Repositioning Therapy, Light Touch Therapy Plus Repositioning Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Risk Ratio (RR)
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	7.49
	Confidence Interval	(2-Sided) 95%; 2.42 to 23.18
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk Difference 0.44 (IC 95%; 0.27-0.60)

4. Primary Outcome

Title	Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
Description	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.
Time Frame	Follow-up at one year of age

Outcome Measure Data

Analysis Population Description

Per Protocol population, defined as participants completing the one year of age follow-up visit.

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".
Measure Participants	41	36
ODDI score <104%	28 58.3%	5 10.4%
ODDI score >=104%	13 27.1%	31 64.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Osteopathic Manipulative Therapy Plus Repositioning Therapy, Light Touch Therapy Plus Repositioning Therapy
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	Risk Ratio (RR)
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	4.91
	Confidence Interval	(2-Sided) 95%; 2.12 to 11.38
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk Difference 0.54 (IC 95; 0.36-0.72)

5. Secondary Outcome

Title	Cranial Proportion Index (CPI)
Description	Change of the width and length diameter measured with Plagiocephalometry.
Time Frame	The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.

Outcome Measure Data

Analysis Population Description

Data were not collected for lack of clinical relevance

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".
Measure Participants	0	0

6. Secondary Outcome

Title	Adverse Event
Description	Symptoms such as irritability accured after the Osteopathic Manipulative Therapy or Light Touch Therapy
Time Frame	From first treatment (1 week post-baseline) up to end of treatment course (3 months).

Outcome Measure Data

Analysis Population Description

Any Adverse Events

Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy	Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Osteopathic Manipulative Therapy (OMTh). They received 6 OMTh in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention were performed by two osteopaths with a specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".	Participants with Nonsynostic Plagiocephaly, ODDI score >= 104% were randomized to Repositioning Therapy plus Light Touch Therapy (LTT). They received 6 LTT in 3 months, as follows: first at baseline, second after 1 week, third after 3 weeks, and then three more visits every 3 weeks. The intervention was performed by two osteopaths with a specific background in paediatric field. Repositioning therapy: It consists of strategies that guide the parents to position the baby "back to sleep".
Measure Participants	48	48
Serious Adverse events	0 0%	0 0%
Other adverse events such as irritability	0 0%	0 0%

Adverse Events

Time Frame	From first treatment (1 week post-baseline) up to end of treatment course (3 months).
Adverse Event Reporting Description	Symptoms such as irritability occured after the Osteopathic Manipulative Therapy or Light Touch Therapy
Arm/Group Title	Osteopathic Manipulative Therapy Plus Repositioning Therapy		Light Touch Therapy Plus Repositioning Therapy
Arm/Group Description	Participants received Osteopathic Manipulative Therapy (OMTh) plus Repositioning Therapy. OMTh: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.		Participants received Light Touch Therapy (LTT) plus Repositioning Therapy. LTT: 6 treatments in 3 months, first at baseline, second at 1 week, third at 3 weeks, and then 3 more at 3 weeks.
All Cause Mortality
	Osteopathic Manipulative Therapy Plus Repositioning Therapy		Light Touch Therapy Plus Repositioning Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Serious Adverse Events
	Osteopathic Manipulative Therapy Plus Repositioning Therapy		Light Touch Therapy Plus Repositioning Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)
Other (Not Including Serious) Adverse Events
	Osteopathic Manipulative Therapy Plus Repositioning Therapy		Light Touch Therapy Plus Repositioning Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/48 (0%)		0/48 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.