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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Osteopathic Manipulative Treatment | Experimental | Patients will be treated once a week with OMT x 8 weeks |
|
| Standard of Care Repositioning | Active Comparator | Patients will only receive repositioning only x 8 weeks and all parents will receive standardized materials to counsel/instruct on the repositioning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cranial Vault Asymmetry Index | Anthropometric measurement of cranial asymmetry | 2 years |
| Head circumference | Standard growth parameter measured in infants | 2 years |
| Weight | Standard growth parameter measured in infants | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Medical history | Patients charts will be reviewed after first year of life to assess for medical issues including otitis media, developmental delay, allergic rhinitis, vision problems, torticollis, hospitalizations, need for a helmet to treat plagiocephaly, colic, reflux/GER, etc. | 12 months |
| Developmental Milestones |
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Inclusions:
Exclusions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kimberly J Wolf, DO | Contact | 619-583-7611 | kimberly.wolf@the-promise.org | |
| Jessica Martone, PhD, MSW | Contact | 619-693-6303 | jessica.martone@the-promise.org |
| Name | Affiliation | Role |
|---|---|---|
| Kimberly J Wolf, DO | Osteopathy's Promise to Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osteopathic Center San Diego | Recruiting | San Diego | California | 92123 | United States |
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| ID | Term |
|---|---|
| D049068 | Plagiocephaly, Nonsynostotic |
| D059041 | Plagiocephaly |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D019465 | Craniofacial Abnormalities |
| D009139 | Musculoskeletal Abnormalities |
| D009140 | Musculoskeletal Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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|
| Standard of Care Repositioning | Behavioral | Parents will receive standardized handouts/materials instructing on repositioning intended to help improve head shape in infants with plagiocephaly. |
|
Patients' enrolled in the study will have developmental stones monitored as per general pediatrician's protocol to screen for developmental delays. |
| 12 months |
| D012046 | Rehabilitation |