FOR PROVIDERS
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
Primary Outcomes:
- Cranial asymmetry measures (in mm)
- Cranial Vault Asymmetry Index (CVAI)
- Head circumference (in cm^3)
Sampling:
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.
Timeline:
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.
Nonsynostotic plagiocephaly, also commonly referred to as positional plagiocephaly (PP) or deformational plagiocephaly (DP), is described as an asymmetrical flattening of the cranium due to sustained external pressure. This cranial deformation can arise prenatally after uterine compression or intrauterine constraints, as well as postnatally due to sleeping position1. The newborn infant has a delicate cranial structure designed to transit the birth canal with flexible bones still partially formed of cartilage, which eventually ossify and fuse into a mature skull. If DP is present at birth or if the infant sleeps with the head preferentially turned to one side, the flattened occipital side shifts forward the forehead, ear, and eye on that side2.
1. Fish D, Lima D. An Overview of Positional Plagiocephaly and Cranial Remolding Orthoses: JPO Journal of Prosthetics and Orthotics. 2003;15(2):37-45. doi:10.1097/00008526-200304000-00002
2. Hummel P, Fortado D. IMPACTING INFANT HEAD SHAPES. Advances in Neonatal Care. 2005;5(6):329-340. doi:10.1016/j.adnc.2005.08.009
For additional reading on how OMT may benefit patients with plagiocephaly, please reference the following studies:
- Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants. Complement Ther Clin Pract. 2011;17(4):193-198. doi:10.1016/j.ctcp.2011.02.001
- Di Renzo M, Laurenti A, Bianchi di Castelbianco F, et al. Osteopathic Evaluation and Positional Plagiocephaly: A Descriptive Study on a Population of Children with ASD. American Journal of Pediatrics. 2022;8:104-110. doi:10.11648/j.ajp.20220802.19Aooe
- King, Hollis H., Mai, Julie, Morelli Haskell, Mary Anne, Wolf, Kimberly and Sweeney, Megan. “Effects of osteopathic manipulative treatment on children with plagiocephaly in the context of current pediatric practice: a retrospective chart review study” Journal of Osteopathic Medicine, 2023. https://doi.org/10.1515/
jom-2023-0168
Estimates of the overall prevalence of DP vary widely. While one source classified DP a “rare disease,” occurring in less than 200,000 individuals in the United States, a more recent clinical trial reported some type of plagiocephaly in 205 out of 440 total infants between 7 to 12 weeks of age – totaling an incidence of approximately 46.6%3-5. At the UCSD Medical School’s Dysmorphology Clinic, a similar study evaluating DP reported 73% percent of newborns had at least one asymmetry – including 42% with facial asymmetry, 62% with head asymmetry, and 13% with mandible asymmetry. In the same study, 10% of infants had at least one asymmetry6.
3. Mawji A, Vollman AR, Hatfield J, McNeil DA, Sauvé R. The incidence of positional plagiocephaly: a cohort study. Pediatrics. 2013;132(2):298-304. doi:10.1542/peds.2012-3438
4. Robinson S, Proctor M. Diagnosis and management of deformational plagiocephaly. J Neurosurg Pediatr. 2009;3(4):284-295. doi:10.3171/2009.1.PEDS08330
5. Lessard S, Gagnon I, Trottier N. Exploring the impact of osteopathic treatment on cranial asymmetries associated with nonsynostotic plagiocephaly in infants. Complement Ther Clin Pract. 2011;17(4):193-198. doi:10.1016/j.ctcp.2011.02.001
6. Stellwagen L, Hubbard E, Chambers C, Jones KL. Torticollis, facial asymmetry and plagiocephaly in normal newborns. Arch Dis Child. 2008;93(10):827-831. doi:10.1136/adc.2007.124123
- Participation in the intervention will last a minimum of 16 weeks after enrollment
- Child will be randomly assigned into the OMT treatment group or standard of care repositioning group and after 8 weeks will switch over into the other group
- Child will receive 8 weeks of treatment and 8 weeks of standard of care repositioning (not necessarily in that order)
- Families will be contacted when child is 12 months to complete a follow-up survey
- The family may choose to pursue helmets, physical therapy, additional OMT, or any other interventions they deem necessary for their child after the 16 weeks of intervention
- Treatment is a non-invasive, hands-on, manual treatment aimed at restoring cranial symmetry
- The standard of care repositioning group will receive a handout focused on repositioning exercises at home
- Families can earn up to $550 for participating in the study
- $40 per in-person treatment visit with an additional $150 for completing the 8 treatment series, $30 per measurement visit, and $20 for completing the follow-up survey when the child is 12 months
Inclusion Criteria
- They are 4-months of age or younger (between birth – 4 months) at the time of enrollment
- They were diagnosed with deformational or positional plagiocephaly by a healthcare provider
Exclusion Criteria
- They are 5 months or older
- They were born preterm (before 37 weeks)
- They were diagnosed with any genetic syndromes
- They were diagnosed with craniofacial defects such as craniosynostosis
- They were diagnosed with hypertonia or hypotonia
- They sustained head trauma or neurological illnesses
- They have had prior helmet therapy, physical therapy, or Osteopathic Manipulative Treatment (OMT)
Status: Accepting new patients
Start Date: November 2023
Completion Date: December 2024 (estimated)
Sponsor: Osteopathy’s Promise to Children
WIRB #: 20233263
ClinicalTrials.gov: NCT05848895
Study Type: Randomized control trial with crossover design
Participants: Aiming to enroll 122 study participants
Last Updated: February 2024
- Contact us at OPT-IN@the-promise.org or 619-693-6303 (Se habla Español).
- Complete our interest form to become a referring healthcare provider and to receive materials to share with your patients and their families
Related Research on Plagiocephaly Treatment
Our Research Team
Kimberly Wolf, DO, FAAP, FACOP, FAAPO
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.
Hollis King, DO, PhD, FAAO, FCA, FAAPO
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.
Jessica Martone, PhD, MSW
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.
Mary Anne Morelli Haskell, DO, FACOP, FCA
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.
Julie Mai, DO
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.