Osteopathic Plagiocephaly Treatment for Infants & Neonates (OPT-IN) Study
This is a two-arm, randomized cross-over clinical trial looking at the benefit of osteopathic manipulative treatment (OMT) in the management of deformational/positional plagiocephaly vs the standard of care repositioning. The researchers will assess the acute benefits of OMT in treating plagiocephaly, as well as potential long-term developmental and health benefits.
The study is for infants 4 months of age and younger who are diagnosed with Deformational (Positional) Plagiocephaly. The infant will be screened and evaluated for study participation and if eligible, randomly assigned to receive an 8-week course of weekly Osteopathic Manipulative Treatment (OMT), a noninvasive, hands-on, manual treatment that aims to restore cranial symmetry, OR standard of care repositioning attention from the parent for 8-weeks (parent will conduct exercises at home using a handout).
After 8 weeks of the OMT or repositioning, participants will then crossover and switch interventions to complete 8 weeks of the opposite therapy (OMT or repositioning, the opposite of which was assigned first). Cranial measurements of the infant’s head will be taken at each of the 8 visits with a camera using SoftSpotTM technology and each of the 2 measurement visits during the time in the repositioning group.
OPT-IN Study Details
- Cranial asymmetry measures (in mm)
- Cranial Vault Asymmetry Index (CVAI)
- Head circumference (in cm^3)
We will enroll 122 participants for this study. A convenience sample will be used and participants and their caregivers/ parents/ guardians will be recruited from the practices of community pediatricians and other healthcare providers (e.g., lactation consultants, midwives, physician assistants, nurse practitioners) throughout San Diego as well as those based at Rady Children’s Hospital in San Diego.
We expect that participation in this research will last for approximately 1-year (12-months). The majority of this participation will occur over 16 consecutive weeks when the child is first enrolled, but the family will also be contacted again when the child is approximately 12 months old to complete a follow-up survey. Recruitment and enrollment will begin in Fall 2023 and we anticipate that the study will run through December 2024.
Related Research on Plagiocephaly
Our Research Team
Dr. Wolf is a graduate of Seton Hall University, South Orange, NJ and Western University of Health Sciences, College of Osteopathic Medicine of the Pacific (COMP), Pomona, CA. She is board certified in Pediatrics. Dr. Wolf was a dually accredited Pediatric Resident at Nationwide Children’s Hospital and Doctor’s Hospital, Columbus, OH. Dr. Wolf is a Fellow of the American Academy of Pediatrics, the American College of Osteopathic Pediatricians and the American Academy of Pediatric Osteopathy. She is currently an Associate Professor of OMM and Director of Pediatric OMM at Touro University California College of Osteopathic Medicine and Research Director for the Osteopathic Center for Children. Her memberships include: AOA, AAO, ACOP, AAP, AAPO, and OCA.
Dr. King is a graduate of Texas College of Osteopathic Medicine, Fort Worth, TX. His postdoctoral training was at Dallas Memorial Hospital, Dallas, TX. His internship was at the VA Hospital & Univ. of Kentucky Medical School, Lexington, KY. His Ph.D. in Clinical Psychology is from Trinity University, San Antonio, TX. Dr. King is board certified in Family Medicine/OMT from the American Osteopathic Board of Family Physicians and certified with Special Proficiency in Osteopathic Manipulative Medicine from the American Osteopathic Board of Neuromusculoskeletal Medicine. He is a Founding Diplomate of the American Board of Holistic and Integrative Medicine. He is a Fellow of and Past-President of the American Academy of Osteopathy. He is a Fellow of the Osteopathic Cranial Academy. Recently Dr. King was made a Fellow of the American Academy of Pediatrics. Dr. King recently retired as Clinical Professor of Family Medicine at the University of California San Diego School of Medicine. He has a private practice at Osteopathic Center San Diego. Dr. King is Research Director at Osteopathy’s Promise to Children. His memberships include: AOA, AAO, OCA and AAPO.
Dr. Martone obtained her PhD and MSW from Loyola University Chicago and has extensive experience conducting research and evaluation. She was the Director for Research and Evaluation at The Mark USA and oversaw 60 concurrent projects in the areas of Science, Technology, Engineering, and Math. Jessica designed the research and evaluation methodology, conducted data collection and analysis and developed and disseminated findings. While at Loyola University Chicago Jessica worked for the Institute on Migration and International Social Work and contributed to several immigration focused research projects, including a global study on immigrant integration to identify best practices for social and economic integration. Jessica was an adjunct faculty member at Cal State Fullerton and taught the Research Capstone course and was an adjunct faculty member at Loyola University Chicago where she taught introduction to social work policy and practice courses. Dr. Martone is a subject matter expert approved by the OPC educational planning committee.
Dr. Haskell is a graduate of the College of Osteopathic Medicine of the Pacific of Western University and completed a year of training in general medicine and then three years of pediatric residency at Loma Linda University Medical Center. She is board certified by the Osteopathic National Boards. She is boarded by the American Osteopathic Board of Pediatrics and the American Osteopathic Board of Neuromusculoskeletal Medicine. She holds a Certificate of Proficiency in Osteopathy in the Cranial Field from the Osteopathic Cranial Academy and is a Fellow of the Osteopathic Cranial Academy. The College d’Etudes Osteopathiques presented Dr. Haskell with the Viola Frymann award for excellence in osteopathic pediatrics. Her memberships include: AOA, AAO, ACOP, and OCA.
Dr. Mai is a graduate of the University of California, San Diego, CA and Touro University College of Osteopathic Medicine, Vallejo, CA. Dr. Mai completed a traditional internship at Chino Valley Hospital in Chino, CA. She holds a Certificate of Proficiency in Osteopathy in the Cranial Field from the Osteopathic Cranial Academy. She serves on the Boards of Osteopathy’s Promise to Children, Osteopathic Center for Children and the Osteopathic Cranial Academy. She served as the President of the Osteopathic Center for Children, and is currently President-Elect for the Osteopathic Cranial Academy. Her memberships are AOA, AAO, OCA, AAPO.