The Effectiveness of Chiropractic in the Treatment of Infantile Colic
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Southampton
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Proportion of infants reported with absence of 'colic'
Study Overview
Brief Summary
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.
Detailed Description
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)).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 1 Day to 12 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •Infants who have received previous chiropractic, osteopathic or other manipulative treatment
Outcomes
Primary Outcomes
Proportion of infants reported with absence of 'colic'
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: at any time during an infant's engagement in the study, circa 28 days
Secondary Outcomes
- 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)