Department of Research, Scuola Superiore di Osteopatia Italiana, Turin, Italy.
Division of Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera Città della Salute e della Scienza di Torino, Turin, Italy.
Am J Perinatol. 2022 Dec;39(S 01):S52-S62. doi: 10.1055/s-0042-1758723. Epub 2022 Nov 30.
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).
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.
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; < 0.001) and at the follow-up at 1 year of age (risk difference: 0.47; 95% CI: 0.31-0.64; < 0.001). The PP analysis at 3 months reported a risk difference of 0.44 (95% CI: 0.27-0.60; < 0.001), and at 1 year of age, a risk difference of 0.54 (95% CI: 0.36-0.72; < 0.001).
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.
gov ).
· 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..
本研究旨在比较整骨手法治疗（OMTh）与轻触疗法（LTT）在减少非骨缝性斜头畸形（NSP）婴儿颅面不对称中的疗效。
这是一项在意大利都灵圣安娜医院新生儿科进行的前瞻性、平行分组、单中心、LTT 对照随机临床试验。研究纳入了 1 至 6 月龄、患有 NSP 的婴儿，随后将其随机分配至研究组（复位治疗加 6 次 OMTh）或对照组（复位治疗加 6 次 LTT）。主要结局是干预结束时（3 个月时）和 1 岁时，斜径差指数（ODDI）评分<104%的降低情况。
共有 96 名婴儿被随机分配至 OMTh 组（48 名）和 LTT 组（48 名），平均年龄分别为 3.1 个月和 3.2 个月，基线 ODDI 评分分别为 110.2 和 108.7%。在 ITT 和 PP 分析中，与 LTT 组相比，OMTh 组 ODDI 评分<104%的显著降低。在 ITT 分析中，3 个月时 OMTh 组的 ODDI 评分<104%（风险差异：0.41；95%置信区间 [CI]：0.25-0.53；<0.001），1 岁时 ODDI 评分<104%（风险差异：0.47；95% CI：0.31-0.64；<0.001）。3 个月时 PP 分析的风险差异为 0.44（95% CI：0.27-0.60；<0.001），1 岁时风险差异为 0.54（95% CI：0.36-0.72；<0.001）。
与 LTT 相比，NSP 婴儿接受 6 次 OMTh 治疗加复位治疗可显著降低 3 个月和 1 岁时的颅面不对称程度。本研究在 ClinicalTrials.gov 注册（标识符：NCT03970395；www.clinicaltrials.gov）。
· OMTh 联合复位治疗可显著降低 NSP 风险和严重程度，优于 LTT。· OMTh 可减轻轻度和中度颅面不对称。· 应在多中心试验中研究 OMTh 在严重颅面不对称中的作用。
