OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates

Conditions

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

Eligibility Criteria

Sex

ALL

Age

1 Day - 4 Months

Healthy Volunteers

Not accepted

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.
• Standard of Care Repositioning — BEHAVIORAL
  Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly.

Study Details

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.

Key Dates

Start date

Oct 26, 2023

Status verified

Mar 2025

Primary completion

Dec 31, 2025

Completion

Dec 31, 2025

Study Design

Enrollment

122 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Experimental: Osteopathic Manipulative Treatment
  Patients will be treated once a week with OMT x 8 weeks
• 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

Primary Outcome Measure

Cranial Vault Asymmetry Index [ Time Frame: 2 years ]

Central Contacts

• Kimberly J Wolf, DO
  619-583-7611
  [email protected]
• Jessica Martone, PhD, MSW
  619-693-6303
  [email protected]

Locations (1)

Find similar trials in San Diego, CA

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