OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates (OPT-IN)

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.

Study Overview

• Status: Recruiting
• Conditions: Plagiocephaly; Plagiocephaly, Nonsynostotic; Plagiocephaly, Positional; Cranium; Deformity
• Intervention / Treatment: Procedure: Osteopathic Manipulative Treatment; Behavioral: Standard of Care Repositioning

• Study Type: Interventional
• Enrollment (Estimated): 122
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kimberly J Wolf, DO; Phone Number: 19373699290; Email: wolfkimb@gmail.com
• Study Contact Backup: Name: Jessica Martone, PhD, MSW; Phone Number: 619-693-6303; Email: jessica.martone@the-promise.org

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Recruiting
      • Osteopathic Center San Diego
      • Contact: Jessica Martone, PhD, MSW; Phone Number: 619-693-6303; Email: jessica.martone@the-promise.org
      • Contact: Kimberly Wolf, DO; Phone Number: 619-693-6303; Email: kimberly.wolf@the-promise.org
      • Principal Investigator: Kimberly Wolf, DO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Behavioral: Standard of Care Repositioning; Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.
Experimental: Osteopathic Manipulative Treatment; Patients will be treated once a week with OMT x 8 weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medical history	Patients charts will be reviewed after first year of life to assess for medical issues including otitis media, developmental delay, allergic rhinitis, vision problems, torticollis, hospitalizations, need for a helmet to treat plagiocephaly, colic, reflux/GER, etc.	12 months
Developmental Milestones	Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays.	12 months

Collaborators and Investigators

• Sponsor: Osteopathy's Promise to Children
• Collaborators: Hollis King, DO
• Investigators: Principal Investigator: Kimberly J Wolf, DO, Osteopathy's Promise to Children

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: April 28, 2023
• First Submitted That Met QC Criteria: April 28, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Osteopathic Manipulative Treatment; Repositioning; Positional Plagiocephaly; Nonsynostotic Plagiocephaly; Cranial asymetry
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Plagiocephaly; Plagiocephaly, Nonsynostotic
• Other Study ID Numbers: OPC001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No