Effectiveness of Osteopathic Manipulative Therapy in Nonsynostotic Plagiocephaly
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
研究概览
简要总结
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.
详细描述
Nonsynostotic plagiocephaly (NSP) is defined as the deformation of the head resulting from external forces that mould the skull during the first months of life.
Four months seems to be a critical age for the development of NSP, but many positional head shape deformities may improve with time.
Early assessment and diagnosis is important not only for the shape of the skull, but also for possible clinical significant differences in gross motor development.
In paediatric conditions the effect of osteopathic manipulative treatment is documented in systematic reviews; in NSP the only study, which is a pilot, reveals an average reduction of 50% asymmetry on 12 infants who have undergone a course of four osteopathic treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Infants were randomly assigned to two groups, OMT and LTT by using a random number generator, prepared in advance by an independent biostatistician. Sequentially numbered, opaque, and sealed envelopes were used.
Clinician-Investigators, neonatology staff, the physical therapist, and the osteopath in charge of assessment were unaware of the random list.
Infants' parents, after having signed the informed consent form, chose the numbered envelope and were unaware of the random list for the whole period of study.
The two osteopaths in charge of Osteopathic manipulative therapy and Light Touch Therapy were unblinded to group assignment.
Clinical outcomes were assessed by a biostatistician who was not involved in the patients' clinical allocation and management.
入排标准
- 年龄范围
- 1 Month 至 6 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants with NSP, ODDI score of 104% or more.
- •To be at term corrected age if born prematurely.
排除标准
- •Synostotic Plagiocephaly
- •Infant who underwent an osteopathic manipulative treatment before the enrolment
- •Dysmorphisms
- •Syndromes
- •Congenital Muscular Torcicolis
- •Cerebral Palsy
结局指标
主要结局
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 1 Year of Age.
时间窗: Follow-up at one year of age
The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of Nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score \>=104\<108 MILD Nonsynostotic Plagiocephaly ODDI score \>=108\<112 MODERATE Nonsynostotic Plagiocephaly ODDI score \>= 112 SEVERE Nonsynostotic Plagiocephaly Higher score means a worse outcome.
Number of Participants With Change From Baseline in ODDI Score (Oblique Diameter Difference Index) to Below 104% at 3 Months
时间窗: At 3 months
The ODDI score being the most clinically relevant measure to define nonsynostotic plagiocephaly. The category of nonsynostotic plagiocephaly is defined by reference to the following score: ODDI score \>=104 Nonsynostotic Plagiocephaly ODDI score \<104 Absence of Nonsynostotic Plagiocephaly Higher score means a worse outcome.
次要结局
- Cranial Proportion Index (CPI)(The change of CPI will be measured at baseline, at 3 months from baseline and follow-up at 1 year of age.)
- Adverse Event(From first treatment (1 week post-baseline) up to end of treatment course (3 months).)
研究者
PRIOLO CLAUDIO
Paediatrician
A.O.U. Città della Salute e della Scienza