Osteopathic treatment for infants with head shape issues
OPT-IN: Osteopathic Plagiocephaly Treatment for Infants and Neonates
This study is testing if a special hands-on treatment can help babies with flat head syndrome get better results than just using regular repositioning methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 122 (estimated) |
| Ages | 1 Day to 4 Months |
| Sex | All |
| Sponsor | Osteopathy's Promise to Children Academic / other |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT05848895 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of osteopathic manipulative treatment (OMT) compared to standard repositioning care in infants diagnosed with positional plagiocephaly. Infants under 4 months of age will be randomly assigned to receive either OMT or standard care for 8 weeks, after which they will switch groups. The primary outcome is to measure improvements in cranial symmetry through anthropometric assessments. The study will involve a total of 122 participants.
Who should consider this trial
Good fit: Ideal candidates are infants under 4 months of age diagnosed with positional plagiocephaly.
Not a fit: Patients with preterm birth, genetic syndromes, or craniofacial defects will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective non-invasive option for correcting cranial asymmetry in infants.
How similar studies have performed: While there is limited data on the specific use of OMT for this condition, similar approaches in treating cranial deformities have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California
- Osteopathic Center San Diego — San Diego, California, United States (Recruiting)
Study contacts
- Principal investigator: Kimberly J Wolf, DO — Osteopathy's Promise to Children
- Study coordinator: Kimberly J Wolf, DO
- Email: kimberly.wolf@the-promise.org
- Phone: 619-583-7611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.