跳至主要内容
临床试验/NCT02595515
NCT02595515已完成不适用

The Effect of Chiropractic Treatment of Infantile Colic. A Randomized, Controlled Trial

Nordic Institute of Chiropractic and Clinical Biomechanics2 个研究点 分布在 1 个国家目标入组 186 人开始时间: 2015年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
186
试验地点
2
主要终点
Change in hours of crying

研究概览

简要总结

Infantile colic is condition that affects more than 10% of babies and their families. The reason, and hence proper treatment, for this condition is unknown and many causes have been suggested. One of the treatments that parents choose is chiropractic manipulation. In Denmark, almost 10,000 babies are each year treated by chiropractors, and a high proportion is due to colic. However, the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.

The effects of chiropractic treatment on infantile colic needs to be investigated, since this is a very common disorder with no known effective treatment, but with good empirical evidence of the value of chiropractic treatment. Although it is usually considered to be a benign and self-limiting condition, some studies suggest there might be long-term effects in terms of psychomotor problems. In worst case, the infants' crying may also lead to violence and 'shaken baby syndrome'.

Null hypothesis: There is no effect of chiropractic treatment on the course of infantile colic.

This study is a controlled, clinical trial where infants fulfilling the diagnostic criteria for colic will be randomized into two groups. One group will receive treatment and the other won't. This will determine the overall effect and furthermore, subgroup analyses will be performed to identify possible subgroups of infants, who will benefit the most from the treatment.

详细描述

OBJECTIVES:

Primary: To investigate the effect of chiropractic treatment on infantile colic

Secondary: to investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without.

METHOD:

A randomized controlled single blind multicenter clinical trial

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)

入排标准

年龄范围
2 Weeks 至 14 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Age: 2-14 weeks.
  • Minimum crying and fussing: three hours per day, three days per week
  • Satisfying weight gain

排除标准

  • Known disease
  • Symptoms than can indicate other condition than infantile colic
  • Contraindications for chiropractic treatment
  • Previous chiropractic treatment due to infantile colic

结局指标

主要结局

Change in hours of crying

时间窗: Two weeks

Change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children

次要结局

  • Change in hours of crying for children with suspected musculo-skeletal problems(Two weeks)

研究者

发起方
Nordic Institute of Chiropractic and Clinical Biomechanics
申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

The Effect of Chiropractic Treatment of Infantile... | 临床试验