OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

NCT ID: NCT05848895

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-26
• Study Completion Date: 2025-12-31

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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Osteopathic Manipulative Treatment

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

Group Type: EXPERIMENTAL

Osteopathic Manipulative Treatment

Intervention Type: 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.

Standard of Care Repositioning

Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning

Group Type: ACTIVE_COMPARATOR

Standard of Care Repositioning

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: PROCEDURE

Standard of Care Repositioning

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 4 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osteopathy's Promise to Children

OTHER

Sponsor Role: lead

Responsible Party

Kimberly Wolf

Kimberly Wolf, DO

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly J Wolf, DO

Role: PRINCIPAL_INVESTIGATOR

Osteopathy's Promise to Children

Locations

Osteopathic Center San Diego

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kimberly J Wolf, DO

Role: CONTACT

kimberly.wolf@the-promise.org

619-583-7611

Jessica Martone, PhD, MSW

Role: CONTACT

jessica.martone@the-promise.org

619-693-6303

Facility Contacts

Jessica Martone, PhD, MSW

Role: primary

jessica.martone@the-promise.org

619-693-6303

Kimberly Wolf, DO

Role: backup

kimberly.wolf@the-promise.org

619-693-6303

Other Identifiers

OPC001

Identifier Type: -

Identifier Source: org_study_id