Nonsynostotic PlagiocephalyNCT03970395

Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly

A study testing Osteopathic manipulative therapy (OMTh), Light Touch Therapy (LTT) and Repositioning therapy in people with Nonsynostotic Plagiocephaly, run by PRIOLO CLAUDIO at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 1 month to 6 months
Conditions the study is for: Nonsynostotic Plagiocephaly
What is being tested?: Osteopathic manipulative therapy (OMTh), Light Touch Therapy (LTT) and Repositioning therapy
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteItaly
Study dates: 1 Sep 2016to 26 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 month to 6 months
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

Other trials in Italy

About this study

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.

Read the 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.

Conditions: Nonsynostotic Plagiocephaly
Being tested: Osteopathic manipulative therapy (OMTh), Light Touch Therapy (LTT), Repositioning therapy
Keywords: Positional Plagiocephaly, Deformational Plagiocephaly,
Medical subject headings: Plagiocephaly, Nonsynostotic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.
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.
Repositioning therapyOther
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.

Study groups in NCT03970395
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Light Touch Therapy (LTT); Other: Repositioning therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow-up at one year of age

Secondary outcomes (2)

Cranial Proportion Index (CPI)
Change of the width and length diameter measured with Plagiocephalometry.
Measured: 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
Measured: From first treatment (1 week post-baseline) up to end of treatment course (3 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201626 Feb 2020

First posted31 May 2019
Study start1 Sep 2016
Primary completion26 Feb 2020
Study completion26 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Nonsynostotic PlagiocephalyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03970395
Sponsor's protocol ID: 0074260
Status last verified: Feb 2021
First submitted: 5 May 2019
Last updated: 12 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 21187783
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.
PubMed 21187782
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.
PubMed 21726785
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.
PubMed 21982132
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.
PubMed 16211401
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.
PubMed 36451623

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Effects of Tummy Time Associated With Therapeutic Positioning in Premature Newborns With Cranial Asymmetry
Premature Newborns, Cranial Asymmetry
Recruiting
Effectiveness of Repositioning and Cranial Remolding in Infants With Cranial Deformation
Deformational Plagiocephaly, Deformational Posterior Plagiocephaly
Not yet recruitingObservational study
Effects of Corrective Helmet Therapy on Cervical Motion and Thermoregulation in Children With Positional Deformities
Plagiocephaly, Nonsynostotic, Brachycephaly
Recruiting
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional
Not yet recruitingObservational study
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
Non Synostotic Plagiocephaly

All Nonsynostotic Plagiocephaly trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
ClinicalTrials.gov ID: NCT03970395
Acronym / sponsor ID: 0074260
Conditions: Nonsynostotic Plagiocephaly
Keywords: Positional Plagiocephaly, Deformational Plagiocephaly,
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: PRIOLO CLAUDIOUniversity, hospital or other
Collaborators: Scuola Superiore di Osteopatia Italiana
Study start: 1 Sep 2016 (actual)
Primary completion: 26 Feb 2020 (actual)
Study completion: 26 Feb 2020 (actual)
First posted: 31 May 2019 (actual)
Results: Posted 24 Sep 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2
Model description: A two arms randomized controlled trial. The experimental group will receive Osteopathic manipulative Therapy and the active comparator the Light Touch Therapy

Arm	Type	Receives
Osteopathic manipulative therapy	Experimental	Other: Osteopathic manipulative therapy (OMTh), Other: Repositioning therapyRepositioning 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.
Light Touch Therapy	Sham comparator	Other: Light Touch Therapy (LTT), Other: Repositioning therapyRepositioning Therapy plus Light Touch Therapy (LTT) Participants to the LTT group receive the LTT protocol at the same date of the OMTh group.

Who may qualify

Ages: 1 month to 6 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (2 listed)

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

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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	Osteopathic manipulative therapy
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	Light Touch Therapy
Repositioning therapyIt 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, Osteopathic manipulative therapy

Primary outcome

Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
Time frame: 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.
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
Time frame: 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.
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
Time frame: 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.
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
Time frame: 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.

2 secondary outcomes

Cranial Proportion Index (CPI)
Time frame: The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.
Adverse Event
Time frame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).

Results and safety

Results posted to the registry on 24 Sep 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Osteopathic Manipulative Therapy Plus Repositioning Therapy	48	41
Light Touch Therapy Plus Repositioning Therapy	48	36

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

Time frame: Baseline and 3 months. Count of participants. Unit: Participants

Measure	Osteopathic Manipulative Therapy Plus Repositioning Therapy n = 48	Light Touch Therapy Plus Repositioning Therapy n = 48
ODDI score <104%	23	3
ODDI score >=104%	25	45

Osteopathic Manipulative Therapy Plus Repositioning Therapy vs Light Touch Therapy Plus Repositioning Therapy: Risk Ratio (RR): 7.66 (95% CI 2.46 to 23.84), p = 0.01, Risk Ratio (RR)

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

Primary outcome: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.

Time frame: Follow-up at 1 year of age. Count of participants. Unit: Participants

Measure	Osteopathic Manipulative Therapy Plus Repositioning Therapy n = 48	Light Touch Therapy Plus Repositioning Therapy n = 48
ODDI score <104%	28	5
ODDI score >=104%	20	43

Osteopathic Manipulative Therapy Plus Repositioning Therapy vs Light Touch Therapy Plus Repositioning Therapy: Risk Ratio (RR): 5.6 (95% CI 2.36 to 13.27), p = 0.01, Relative Risk (RR)

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

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

Time frame: At 3 months. Count of participants. Unit: Participants

Measure	Osteopathic Manipulative Therapy Plus Repositioning Therapy n = 45	Light Touch Therapy Plus Repositioning Therapy n = 44
ODDI score <104%	23	3
ODDI score >=104%	22	41

Osteopathic Manipulative Therapy Plus Repositioning Therapy vs Light Touch Therapy Plus Repositioning Therapy: Risk Ratio (RR): 7.49 (95% CI 2.42 to 23.18), p = 0.01, Risk Ratio (RR)

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

Primary outcome: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.

Time frame: Follow-up at one year of age. Count of participants. Unit: Participants

Measure	Osteopathic Manipulative Therapy Plus Repositioning Therapy n = 41	Light Touch Therapy Plus Repositioning Therapy n = 36
ODDI score <104%	28	5
ODDI score >=104%	13	31

Osteopathic Manipulative Therapy Plus Repositioning Therapy vs Light Touch Therapy Plus Repositioning Therapy: Risk Ratio (RR): 4.91 (95% CI 2.12 to 11.38), p = 0.01, Risk Ratio (RR)

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first treatment (1 week post-baseline) up to end of treatment course (3 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Osteopathic Manipulative Therapy Plus Repositioning Therapy	0 of 48 (0%)	0 of 48 (0%)	0 of 48
Light Touch Therapy Plus Repositioning Therapy	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21187783Rogers 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.
Background: PubMed 21187782Rogers 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.
Background: PubMed 21726785Lennartsson 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.
Background: PubMed 21982132Lessard 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.
Background: PubMed 16211401van 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.
Derived from this study: PubMed 36451623Bagagiolo 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Claudio G Priolo, Medical study director

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

Daniele Farina, Medical principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Osteopathic manipulative therapy (OMTh), Light Touch Therapy (LTT) and Repositioning therapy in people with Nonsynostotic Plagiocephaly, run by PRIOLO CLAUDIO at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months (time frame: Baseline and 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03970395, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.