Plagiocephaly, NonsynostoticOPT-INNCT05848895
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
A study testing Osteopathic Manipulative Treatment in people with Plagiocephaly, Nonsynostotic and Plagiocephaly, Positional, run by Osteopathy's Promise to Children at 1 site in United States.
Trial summary
The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. Read more about this study
- Who is it for?
- Ages 1 day to 4 months
- Conditions the study is for
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly
- What is being tested?
- Osteopathic Manipulative Treatment
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 day to 4 months
- All sexes
- No healthy volunteers
- Child
Inclusions:
- Diagnosed with positional plagiocephaly
- Under 4-months of age (between birth - 4 months) at the time of enrollment
Exclusions:
- Preterm birth (<37 weeks)
- Genetic syndromes
- Craniofacial defects/deformities (e.g. cleft lip/palate)
- Brachycephaly/scaphocephaly
- Hypotonia
- Hypertonia
- Craniosynostosis
- Head trauma or other neurological illnesses
- Lost to follow up
- Patient whose parents (or legal guardians) disagree to attend 8-treatments of OMT and 2 additional measurement sessions
- Prior helmet therapy, physical therapy, or OMT before the date of enrollment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Osteopathic Center San Diego
San Diego, California, 92123
Jessica Martone, PhD, MSW, 619-693-6303, jessica.martone@the-promise.org
Kimberly Wolf, DO, 619-693-6303, kimberly.wolf@the-promise.org
About this study
The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning.
This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants <4 months of age) will be organized into one of two groups:
Read more
- Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.
- Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy).
Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.
- Conditions
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly, Cranium; Deformity
- Being tested
- Osteopathic Manipulative Treatment, Standard of Care Repositioning
- Keywords
- Positional Plagiocephaly, Nonsynostotic Plagiocephaly, Repositioning, Osteopathic Manipulative Treatment, Cranial asymetry
- Medical subject headings
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Osteopathic Manipulative TreatmentProcedure or surgery
Osteopathic Manipulative Treatment is a manual treatment therapy applied by licensed physicians that consists of using ones hands to improve the structure and function of the body. In this situation it will involve gentle and passive modalities that are well-tolerated by infants.
Standard of Care RepositioningBehavioural
Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.
| Study group | Role | What they receive |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Patients will be treated once a week with OMT x 8 weeks Receives: Procedure: Osteopathic Manipulative Treatment |
| Standard of Care Repositioning | Active comparator | Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning Receives: Behavioral: Standard of Care Repositioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial Vault Asymmetry Index
Anthropometric measurement of cranial asymmetry
Measured: 2 years
Head circumference
Standard growth parameter measured in infants
Measured: 2 years
Weight
Standard growth parameter measured in infants
Measured: 2 years
Secondary outcomes (2)
Medical history
Patients charts will be reviewed after first year of life to assess for medical issues including otitis media, developmental delay, allergic rhinitis, vision problems, torticollis, hospitalizations, need for a helmet to treat plagiocephaly, colic, reflux/GER, etc.
Measured: 12 months
Developmental Milestones
Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start26 Oct 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plagiocephaly, NonsynostoticStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 122 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Osteopathy's Promise to Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberly Wolf, Osteopathy's Promise to Children
- Investigators
- Kimberly J Wolf, DO, Principal investigator, Osteopathy's Promise to Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848895
- Sponsor's protocol ID
- OPC001
- Acronym
- OPT-IN
- Status last verified
- Mar 2025
- First submitted
- 28 Apr 2023
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
- ClinicalTrials.gov ID
- NCT05848895
- Acronym / sponsor ID
- OPT-IN / OPC001
- Conditions
- Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly, Cranium; Deformity
- Keywords
- Positional Plagiocephaly, Nonsynostotic Plagiocephaly, Repositioning, Osteopathic Manipulative Treatment, Cranial asymetry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 122 participants (estimated)
- Lead sponsor
- Osteopathy's Promise to ChildrenUniversity, hospital or other
- Study start
- 26 Oct 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this crossover randomized clinical trial is to assess the effects of osteopathic manipulative treatment (OMT) compared to standard of care repositioning in children diagnosed with positional/deformational plagiocephaly. The main hypothesis is that children who received OMT will show significantly improved anthropometric measures of cranial symmetry over those receiving the current pediatric standard of care of repositioning.
This is a two-arm, randomized cross-over clinical trial. With parental consent, pediatric patients (infants <4 months of age) will be organized into one of two groups:
- Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.
- Those who receive standard care only with repositioning attention from the parents After 8-weeks of being in the first group, each participant will cross-over into the second group (OMT or repositioning) N = 122 subjects diagnosed with deformational plagiocephaly (DP) are to be recruited (to allow for natural attrition and loss to follow up) with the recruitment to continue until 61 patients have been placed in each of the two groups and will cross-over to the respective treatment group (OMT and standard of care repositioning therapy).
Timeline: It is projected that to recruit and carry out the assessments and interventions (8-weeks of each group with 12-months of follow-up longitudinally), it will require two years (24-months) from the beginning of the study to completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Procedure: Osteopathic Manipulative TreatmentPatients will be treated once a week with OMT x 8 weeks |
| Standard of Care Repositioning | Active comparator | Behavioral: Standard of Care RepositioningPatients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning |
Who may qualify
- Ages
- 1 day to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 TreatmentOsteopathic Manipulative Treatment is a manual treatment therapy applied by licensed physicians that consists of using ones hands to improve the structure and function of the body. In this situation it will involve gentle and passive modalities that are well-tolerated by infants. | Procedure or surgery | Osteopathic Manipulative Treatment |
| Standard of Care RepositioningParents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly. | Behavioural | Standard of Care Repositioning |
Primary outcome
Cranial Vault Asymmetry Index
Time frame: 2 years
Anthropometric measurement of cranial asymmetry
Head circumference
Time frame: 2 years
Standard growth parameter measured in infants
Weight
Time frame: 2 years
Standard growth parameter measured in infants
2 secondary outcomes
Medical history
Time frame: 12 months
Developmental Milestones
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Plagiocephaly, Nonsynostotic
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
Not yet recruitingObservational study
Head Circumference Evolution in Children With Positional Plagiocephaly During and After Molding Helmet Therapy.
Non Synostotic Plagiocephaly
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.
Kimberly J Wolf, DO principal investigator
Osteopathy's Promise to Children
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 Treatment in people with Plagiocephaly, Nonsynostotic and Plagiocephaly, Positional, run by Osteopathy's Promise to Children at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: looking for participants now, as of the sponsor's last update on 3 Aug 2025. 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 United States. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kimberly J Wolf, DO (619-583-7611, kimberly.wolf@the-promise.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cranial Vault Asymmetry Index (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2025.