The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Decrease in hours of crying
研究概览
简要总结
Infantile colic is a condition that affects more than 10% of babies and their families. The reason, and hence the 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, around 4,000 babies are treated for colic by chiropractors each year although the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.
The effect 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.
The results from subgroup analyses can help to identify children who might benefit from the treatment. Then treatment can be initiated early and a lot of hardship can be avoided for both the babies and the families.
详细描述
OBJECTIVES:
Primary: To investigate the effect of chiropractic treatment on infantile colic.
Secondary: A) To investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without. B) To investigate whether health visitors and chiropractors can agree on the diagnosis of "suspected musculoskeletal problems".
METHOD:
A randomized controlled single blind multicenter clinical trial with a nested case-crossover study.
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 10 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 2-10 weeks.
- •Minimum crying and fussing: three hours per day, three days per week.
排除标准
- •Known disease.
- •Unsatisfying weight gain.
- •Psychological or developmental compromise.
- •Contraindications for chiropractic treatment.
结局指标
主要结局
Decrease in hours of crying
时间窗: Two weeks
次要结局
未报告次要终点
