Effects of Osteopathic Manual Therapy on Infant Colic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 6
- 主要终点
- Total hours of crying per day
研究概览
简要总结
Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to CL treatment.
The main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of CL, the frequency of episodes, changes in stool and possible adverse effects.
The study hypothesis argues that the application of osteopathic manual therapy in babies with CL produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. A controlled RCT will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (EG) and control group (CG) using a table of random numbers by a person from outside the research. The EG diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. The CG has no treatment.
A total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required).
The therapist in charge of performing the operations will be a Physiotherapist and Osteopath with more than 10 years of experience.
The evaluations will be carried out by a healthcare professional with more than 10 years of experience. The evaluator will be blinded. Parents blinded with respect to the allocation group of each subject until the end of the study.
To analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. The Infantile Colic Severity Questionnaire (ICSQ) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).
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
- Double (Care Provider, Outcomes Assessor)
盲法说明
The evaluator will be blinded. Parents will be blinded to the allocation group to which each subject belongs until the end of the study
入排标准
- 年龄范围
- 2 Weeks 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks.
- •Age 2 - 12 weeks.
- •Gestation equal to or greater than 38 weeks.
- •Birth weight equal to or greater than 2,500 grams.
- •Weight gain of at least 150 grams. per week.
- •Appropriate pediatric general physical examination (height, weight, head circumference and psychomotor development).
- •Sign the informed consent.
排除标准
- •Signs and / or symptoms of other pathologies.
- •Signs of lactose intolerance.
- •Having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein.
- •Having received the subjects and / or siblings, previous treatment with Osteopathy and / or Chiropractic.
- •Contraindication to the treatment and / or some of its techniques; presence of congenital malformations.
结局指标
主要结局
Total hours of crying per day
时间窗: Finally at 4 weeks from the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Frequency of episodes
时间窗: Finally at 4 weeks from the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
次要结局
- Use of drugs(At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study)
- Colic Severity(At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study)
- Hours of sleep(At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study)
- Stool(At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study)
研究者
David Nuñez Fernandez
Principal Investigator
University of Seville