The Effectiveness of Chiropractic in the Treatment of Infantile Colic
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Proportion of infants reported with absence of 'colic'
研究概览
简要总结
The purpose of this study is to investigate whether a course of chiropractic treatment has a significant impact on the natural course of infantile colic, specifically:
- Do parents of colicky infants randomised to the groups receiving a course of McTimoney chiropractic treatment:
- report a significantly greater improvement in hours of crying than those in the control group?
- report a significantly greater improvement their own quality of life (anxiety and depression)?
- report "resolution" of colic following treatment than the control group?
- What effect does parental blinding have on parentally-reported symptoms of infantile colic and parental quality of life?
The study will also include exploratory investigations to determine whether there are:
- Any particular groupings of patient characteristics (for example; 'other' presenting symptoms, position in the natural course of colic, age of onset, spinal dysfunction, perinatal factors) that are associated with good or poor outcomes
- Any particular characteristics of the treatment (e.g. specific adjustments) that are associated with good or poor outcomes.
详细描述
Overall Design
The study will be a two-by-two factorial design combining groups of chiropractic treatment or 'Best Standard Care' with blinded or unblinded parents.
The two treatment groups will be 'Best Standard Care only' (BSC) and 'Best Standard Care plus chiropractic' (Chiro). Best standard care will be based on the recommendations from United Kingdom (UK) National Health Service (NHS), using the Map of Medicine care map. Chiropractic treatment will be delivered according to the protocol defined by the participating chiropractors.
There will be two blinded and two unblinded groups. The blinded BSC group will receive the 'sham' treatment in addition to the BSC counselling. The unblinded BSC group will not require this.
In addition, to allow the effects of the n-shaped curve inherent in the natural course of colic to be evaluated, all groups will be stratified by age at entry (below 4 weeks (expected increasing crying over the 2 weeks of the main intervention), between 4 and 6 weeks (expected plateau), and over 6 weeks (decreasing crying)).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 12 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parentally-reported crying of more than three hours per day for three or more days in the preceding week (reported at initial contact to determine preliminary diagnosis of colic)
- •Confirmation at first clinic visit that the infant has cried for more than three hours per day for at least one day in the base-lining period.
- •Otherwise normal infants, born at term, with normal growth and development, and no indication of other underlying pathology
- •Parents fluent in English, providing informed written consent
排除标准
- •Infants who have received previous chiropractic, osteopathic or other manipulative treatment
结局指标
主要结局
Proportion of infants reported with absence of 'colic'
时间窗: Follow-up telephone call after first, mid point and final clinic visit (approx days 2, 8 and 15)
Taken from the Parental Global Impression of Severity scale
Changes to the duration of crying per day
时间窗: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)
Proportion of infants achieving clinically-relevant reduction in crying time
时间窗: Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)
Defined as 60 minutes (median) based on survey
Number of adverse events
时间窗: at any time during an infant's engagement in the study, circa 28 days
次要结局
- Proportion of infants achieving clinically-relevant reduction in crying time(From baseline to day 21 and day 28 follow ups)
- Proportion of infants reported with absence of 'colic'(At day 21 and day 28 (final 2 follow-ups))
- Effectiveness of Blinding(immediately after first "treatment" (day 1) and at follow-up telephone questionnaires after first, mid point and final clinic visits (~day 2, 8 and 15))
- Changes to the duration of crying per day(baseline to day 21 and day 28)
- Change to Parental Global Impressions of Severity(Baseline to follow-ups after first second and final clinic visits (~days 2, 8, 15) then to day 21 and day 28 follow ups)
- Changes to parental anxiety and depression scores(first visit (day 1) to each of the 5 follow-up questionnaires (~day 2, 8, 15, 21 & 28))
- Parental Global Impressions of Change in symptoms(At each of the follow-up questionanaires (~day 2, 8, 15, 21 and 28))
- Cost of NHS resources used(Reported 'during the preceding week' at each telephone questionnaire (~day 2, 8, 15, 21 and 28))
- Change to Severity of colic-related specific symptoms(Baseline to day after first, mid point and final clinic visits (~days 2, 8, 15) then to day 21 and day 28)