OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

NCT05848895 | Recruiting DMC

• 1 other identifier: OPC001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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. 1.Those who receive OMT with emphasis on osteopathic cranial manipulative medicine (OCMM) to restore cranial symmetry.
2. 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).

Conditions

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

Keywords

Positional Plagiocephaly; Nonsynostotic Plagiocephaly; Repositioning; Osteopathic Manipulative Treatment; Cranial asymetry

Outcome Measures

Primary Outcomes (3)

• Cranial Vault Asymmetry Index

  Anthropometric measurement of cranial asymmetry

  2 years

• Head circumference

  Standard growth parameter measured in infants

  2 years

• Weight

  Standard growth parameter measured in infants

  2 years

Secondary Outcomes (2)

• Medical history

  12 months

• Developmental Milestones

  12 months

Study Arms (2)

Osteopathic Manipulative Treatment

EXPERIMENTAL

Patients will be treated once a week with OMT x 8 weeks

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

Behavioral: Standard of Care Repositioning

Interventions

Osteopathic Manipulative Treatment PROCEDURE

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.

Osteopathic Manipulative Treatment

Standard of Care Repositioning BEHAVIORAL

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

Standard of Care Repositioning

Eligibility Criteria

• Age: 1 Day - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Osteopathy's Promise to Children: lead

Study Sites (1)

Osteopathic Center San Diego

San Diego, California, 92123, United States

RECRUITING

MeSH Terms

Conditions

Plagiocephaly, Nonsynostotic; Plagiocephaly; Congenital Abnormalities

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Kimberly J Wolf, DO

  Osteopathy's Promise to Children

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly J Wolf, DO

CONTACT

619-583-7611; kimberly.wolf@the-promise.org

Jessica Martone, PhD, MSW

CONTACT

619-693-6303; jessica.martone@the-promise.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Kimberly Wolf, DO

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 8, 2023
• Study Start: October 26, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)