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OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

NCT05848895 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2025-08-03

No results posted yet for this study

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.

Conditions

  • Plagiocephaly, Nonsynostotic
  • Plagiocephaly, Positional
  • Plagiocephaly
  • Cranium; Deformity

Interventions

PROCEDURE

Osteopathic 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.

BEHAVIORAL

Standard of Care Repositioning

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

Sponsors & Collaborators

  • Osteopathy's Promise to Children

    lead OTHER

Principal Investigators

  • Kimberly J Wolf, DO · Osteopathy's Promise to Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
1 Day
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-26
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05848895 on ClinicalTrials.gov