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