RecruitingNot ApplicableNCT05848895

OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates


Sponsor

Osteopathy's Promise to Children

Enrollment

122 participants

Start Date

Oct 26, 2023

Study Type

INTERVENTIONAL

Conditions

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. 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.


Eligibility

Min Age: 1 DayMax Age: 4 Months

Plain Language Summary

Simplified for easier understanding

This study (OPT-IN) tests whether osteopathic manipulative treatment (OMT) — a hands-on physical therapy approach used by osteopathic physicians — can improve positional plagiocephaly in young infants. Positional plagiocephaly is an asymmetrical flattening of the back or side of an infant's head, typically caused by spending too much time in one position. It has become increasingly common following public health recommendations for babies to sleep on their backs. While repositioning and helmet therapy are standard treatments, OMT offers a gentle, non-invasive alternative that may address underlying muscle tension (particularly torticollis) that causes infants to prefer one head position. Eligible participants must be infants diagnosed with positional plagiocephaly who are under 4 months of age at the time of enrollment. Preterm infants (born before 37 weeks), babies with genetic syndromes, craniofacial abnormalities, craniosynostosis (where skull bones fuse prematurely), muscle tone disorders, head trauma, or prior treatment with helmets, physical therapy, or OMT are not eligible. Infant participants will receive 8 sessions of osteopathic manipulative treatment, with head shape measurements taken at additional visits to track improvement. This research is important because plagiocephaly is common (affecting up to 50% of infants in some studies), can cause cosmetic and potentially developmental concerns if severe, and helmet therapy — the most effective current treatment — is expensive, requires continuous wear, and is often distressing for infants and families. An effective non-invasive alternative would be genuinely valuable.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREOsteopathic Manipulative Treatment

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.

BEHAVIORALStandard of Care Repositioning

Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.


Locations(1)

Osteopathic Center San Diego

San Diego, California, United States

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NCT05848895


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