| Registry | NCT05848895, acronym OPT-IN |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, treatment |
| Enrollment | 122 (Estimated) |
| Sponsor | Osteopathy's Promise to Children (Other) |
| Conditions | Plagiocephaly, Nonsynostotic, Plagiocephaly, Positional, Plagiocephaly, Cranium; Deformity |
| Interventions | Osteopathic Manipulative Treatment, Standard of Care Repositioning (Procedure, behavioral) |
| Dates | start 2023-10-26, primary completion 2025-12-01 (estimated), completion 2025-12-01 (estimated), first posted 2023-05-08, last updated 2025-08-03 |
| Locations | 1 site in United States |
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All trials for Plagiocephaly, Nonsynostotic All trials for Plagiocephaly, Positional All trials of Osteopathic Manipulative Treatment All trials of Standard of Care Repositioning
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Procedure: Osteopathic Manipulative Treatment | Patients will be treated once a week with OMT x 8 weeks |
| Standard of Care Repositioning | Active comparator | Behavioral: 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 |
Sex: All, ages: 1 Day to 4 Months
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
| Facility | City | Country | Status |
|---|---|---|---|
| Osteopathic Center San Diego | San Diego, California | United States | Recruiting |