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Published on: February 5, 2019
A Randomized Controlled Trial of Osteopathic Manipulative Therapy to Reduce Cranial Asymmetries in Young Infants with
Donatella Bagagiolo1, Claudio G Priolo2, Elena M Favre1
1Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy.
Insights
Osteopathic manipulative therapy (OMTh) significantly reduced cranial asymmetries in infants with nonsynostotic plagiocephaly (NSP) compared to light touch therapy (LTT). OMTh therapy proved effective for mild to moderate cases, warranting further investigation for severe asymmetries.
Area of Science:
- Pediatrics
- Neurology
- Osteopathic Medicine
Background:
- Nonsynostotic plagiocephaly (NSP) is a common condition in infants characterized by cranial asymmetry.
- Early intervention is crucial for managing NSP and preventing potential developmental issues.
- Osteopathic manipulative therapy (OMTh) is a potential treatment modality for NSP.
Purpose of the Study:
- To compare the efficacy of osteopathic manipulative therapy (OMTh) versus light touch therapy (LTT) in reducing cranial asymmetries in infants with NSP.
- To assess the effectiveness of OMTh in conjunction with repositioning therapy.
Main Methods:
- A prospective, randomized clinical trial involving 96 infants aged 1-6 months with NSP.
- Infants were assigned to either OMTh plus repositioning therapy or LTT plus repositioning therapy for six sessions.
- Cranial asymmetry was measured using the oblique diameter difference index (ODDI) score at 3 months and 1 year of age.
Main Results:
- The OMTh group showed a significantly greater reduction in ODDI scores compared to the LTT group at both 3-month and 1-year follow-ups.
- Intention-to-treat analysis indicated a risk difference of 0.41 (p < 0.001) at 3 months and 0.47 (p < 0.001) at 1 year for achieving an ODDI score <104%.
- Per-protocol analysis yielded similar significant results, with risk differences of 0.44 (p < 0.001) at 3 months and 0.54 (p < 0.001) at 1 year.
Conclusions:
- Six sessions of OMTh, combined with repositioning therapy, significantly reduce cranial asymmetries in infants with NSP compared to LTT.
- OMTh is effective in managing mild and moderate cases of NSP.
- Further multicenter trials are recommended to investigate the role of OMTh in severe cranial asymmetries.
Objective:
This study aimed to compare the efficacy of osteopathic manipulative therapy (OMTh) versus light touch therapy (LTT) in reducing cranial asymmetries in infants with nonsynostotic plagiocephaly (NSP).
Study Design:
A prospective, parallel-group, single-center, LTT-controlled randomized clinical trial was conducted in the Department of Neonatology of Sant'Anna Hospital in Turin, Italy, from September 6, 2016 to February 20, 2020. We enrolled infants of 1 to 6 months of age with NSP, who were then randomly assigned to the study group (repositioning therapy plus six sessions of OMTh) or the control group (repositioning therapy plus six sessions of LTT). The outcome was the reduction of the oblique diameter difference index (ODDI) score <104%, which was assessed at the end of the intervention protocol (at 3 months) and at 1 year of age.
Results:
A total of 96 infants were randomized, 48 in the OMTh group and 48 in the LTT group, with mean ages of 3.1 versus 3.2 months, and baseline ODDI score of 110.2 versus 108.7%. In the OMTh group, a significant reduction of the ODDI score <104%, compared with the LTT group, was observed in the intension-to-treat (ITT) and per-protocol (PP) analyses. The ITT analysis revealed an ODDI score <104% in the OMTh group at 3 months (risk difference: 0.41; 95% confidence interval [CI]: 0.25-0.53; p < 0.001) and at the follow-up at 1 year of age (risk difference: 0.47; 95% CI: 0.31-0.64; p < 0.001). The PP analysis at 3 months reported a risk difference of 0.44 (95% CI: 0.27-0.60; p < 0.001), and at 1 year of age, a risk difference of 0.54 (95% CI: 0.36-0.72; p < 0.001).
Conclusion:
In infants with NSP, a course of six OMTh sessions significantly reduced cranial asymmetries at both the 3-month and 1-year follow-up assessments, compared with LTT. This study is registered with ClinicalTrial.gov (identifier: NCT03970395; www.
Clinicaltrials:
gov ).
Key Points:
· OMTh plus repositioning therapy significantly decreased the risk and severity of NSP compared with LTT.. · OMTh reduced mild and moderate cranial asymmetries.. · The role of OMTh in severe cranial asymmetries should be investigated in a multicenter trial..
