Introduction: In Germany in recent years, a growing number of parents are seeking help from osteopaths for the perceived health complaints of their infants and children. However, reliable evidence for the effectiveness of osteopathic interventions for this group of patients is largely lacking. Objective: To observe and document changes in the symptoms of certain health disturbances, as perceived by parents, during the course of an osteopathic treatment of their baby, and associated side effects. Methods: A single-arm, prospective, multicenter, observational study was chosen as the study design. Parents who contacted an osteopathic practice with any of the following 5 health disturbances were invited to include their baby into the study: idiopathic infant asymmetry (IA), deformational plagiocephaly (DP), feeding disorders (FD), excessive crying (EC), and sleep disorders (SD). Osteopaths performed osteopathic treatment as usual for these conditions, and the parents were asked to rate the perceived severity of symptoms on standardized forms including numerical rating scales (NRS 0–10). In DP, the head circumference of the child’s skull was measured with a craniometer, and the cranial vault index (CVAI) was calculated. Results: 230 osteopaths agreed to participate, 151 osteopaths returned parental ratings. 1,136 infants were treated 2.8 ± 1.1 times (mean ± SD). IA was the most prevalent disturbance (48%), followed by EC (18%), FD (15%), DP (14%), and SD (4%). In IA, perceived asymmetry as rated on the NRS improved from 6.1 to 1.1, a mean improvement of 82%. In DP, the CVAI improved from 8.0 to 4.0%, a mean improvement of 51%. FD improved by 77%, EC by 70% (from 7.7 to 2.3 on the NRS) and SD by 56%. Adverse reactions with a timely association with osteopathic treatments were reported in 3.5% of all treatments, probably reflecting typical day-to-day variations in symptoms. In a total of 3,212 treatments, there was not a single serious adverse reaction affecting infant health. Conclusions: This is one of the largest studies worldwide to date on the osteopathic treatment of infants. Osteopathic treatment was associated with major positive changes in the severity of perceived health complaints as assessed by parents, which in most cases were resolved as a matter of concern, and was proved to be a safe treatment modality among a large number of therapists. Based on these results, confirmatory intervention studies can and should be planned and conducted.
Complement Med Res

中文翻译：

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婴儿出生第一年的整骨治疗：一项前瞻性多中心观察性研究（OSTINF 研究）

简介：近年来，在德国，越来越多的父母因婴儿和儿童的健康问题而寻求整骨医生的帮助。然而，在很大程度上缺乏关于整骨疗法对这组患者的有效性的可靠证据。目的：观察和记录父母在婴儿整骨治疗过程中所感知的某些健康障碍症状的变化以及相关的副作用。方法：选择一项单臂、前瞻性、多中心、观察性研究作为研究设计。邀请与患有以下 5 种健康障碍中的任何一种的整骨疗法诊所联系的父母将他们的婴儿纳入研究：特发性婴儿不对称 (IA)、变形性斜头畸形 (DP)、喂养障碍 (FD)、过度哭泣 (EC) 和睡眠障碍（SD）。整骨医生像往常一样对这些情况进行整骨治疗，并要求父母以包括数字评分量表 (NRS 0-10) 在内的标准化形式对感知到的症状严重程度进行评分。在DP中，使用颅骨计测量儿童颅骨的头围，并计算颅穹顶指数（CVAI）。结果：230 名整骨医生同意参与，151 名整骨医生返回了父母的评级。1,136 名婴儿接受了 2.8 ± 1.1 次治疗（平均值 ± SD）。IA 是最普遍的干扰 (48%)，其次是 EC (18%)、FD (15%)、DP (14%) 和 SD (4%)。在 IA 中，根据 NRS 评定的感知不对称性从 6.1 提高到 1.1，平均提高了 82%。在 DP 中，CVAI 从 8.0% 提高到 4.0%，平均提高了 51%。FD 提高了 77%，EC 提高了 70%（在 NRS 上从 7.7 提高到 2.3），SD 提高了 56%。3.5% 的治疗报告了及时与整骨疗法相关的不良反应，这可能反映了典型的日常症状变化。在总共 3,212 次治疗中，没有发生任何影响婴儿健康的严重不良反应。结论：这是迄今为止全球最大的婴儿整骨疗法研究之一。整骨疗法与父母评估的感知健康问题严重程度的重大积极变化有关，在大多数情况下，这些问题作为关注问题得到解决，并且在大量治疗师中被证明是一种安全的治疗方式。基于这些结果，可以而且应该计划和实施验证性干预研究。
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