N/A
N=96
Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
Nonsynostotic Plagiocephaly
Bottom Line
View on ClinicalTrials.gov: NCT03970395 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months — 23; 3; 25; 45 Participants — p=0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Osteopathic manipulative therapy (OMTh) (Other); Light Touch Therapy (LTT) (Other); Repositioning therapy (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- PRIOLO CLAUDIO
- Primary completion
- Feb 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months |
23; 3; 22; 41 | 0.01 sig |
| PRIMARY Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. |
28; 5; 13; 31 | 0.01 sig |
| PRIMARY Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months |
23; 3; 22; 41 | 0.01 sig |
| PRIMARY Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age. |
28; 5; 13; 31 | 0.01 sig |
| SECONDARY Cranial Proportion Index (CPI) |
— | — |
| SECONDARY Adverse Event |
0; 0; 0; 0 | — |
Summary
The aim of this trial is to evaluate the effectiveness of osteopathic manipulative therapy in reducing the asymmetries of skull in infants with nonsynostotic plagiocephaly.
Eligibility Criteria
Inclusion Criteria
- Infants with NSP, ODDI score of 104% or more.
- To be at term corrected age if born prematurely.
Exclusion Criteria
- Synostotic Plagiocephaly
- Infant who underwent an osteopathic manipulative treatment before the enrolment
- Dysmorphisms
- Syndromes
- Congenital Muscular Torcicolis
- Cerebral Palsy
Data sourced from ClinicalTrials.gov (NCT03970395). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.