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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
Who can join
1 Day – 4 Months · All sexes
Full eligibility criteria
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
About the 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:
1. Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry. 2. 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.
What is being tested
- Osteopathic Manipulative Treatment (procedure)
- Standard of Care Repositioning (behavioral)
Sponsor: Osteopathy's Promise to Children · Participants: 122 · Started: Oct 26, 2023
Contact the study team
- Kimberly J Wolf, DO · Phone: 619-583-7611
- Jessica Martone, PhD, MSW · Phone: 619-693-6303
Official record on ClinicalTrials.gov — NCT05848895
Locations in the U.S.
| California | Osteopathic Center San Diego, San Diego |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.