Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

CHiropractic for Infantile Colic Study (CHIC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02138656
Recruitment Status : Terminated (Review of recruitment methods)
First Posted : May 14, 2014
Last Update Posted : May 4, 2017
Sponsor:
Collaborator:
McTimoney College of Chiropractic
Information provided by (Responsible Party):
University of Southampton

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:

  1. 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?
  2. 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:

  1. 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
  2. Any particular characteristics of the treatment (e.g. specific adjustments) that are associated with good or poor outcomes.

Condition or disease Intervention/treatment Phase
Infantile Colic Other: Chiropractic Other: Best Standard Care Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effectiveness of Chiropractic in the Treatment of Infantile Colic
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chiropractic

Arm Intervention/treatment
Active Comparator: Best standard care only - not blind

Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice.

Parents aware that infant is not receiving chiropractic treatment

Other: Best Standard Care
Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic

Sham Comparator: Best Standard Care and Sham - Blind
Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus sham chiropractic treatment. Parents unaware of whether infant is receiving real treatment or sham.
Other: Best Standard Care
Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic

Experimental: BSC & Chiropractic - Not blind

Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus real chiropractic treatment.

Parents aware that infant is receiving chiropractic treatment.

Other: Chiropractic
Chiropractic treatment delivered in accordance with clinical protocols developed and agreed with the participant clinicians

Other: Best Standard Care
Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic

Experimental: BSC & Chiropractic - Blind

Best Standard Care (as defined by Map of Medicine care pathway) - counseling and advice plus real chiropractic treatment.

Parents not aware that infant is receiving chiropractic treatment.

Other: Chiropractic
Chiropractic treatment delivered in accordance with clinical protocols developed and agreed with the participant clinicians

Other: Best Standard Care
Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic




Primary Outcome Measures :
  1. 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) ]
  2. 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

  3. 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

  4. Number of adverse events [ Time Frame: at any time during an infant's engagement in the study, circa 28 days ]

Secondary Outcome Measures :
  1. Changes to the duration of crying per day [ Time Frame: baseline to day 21 and day 28 ]
  2. Changes to parental anxiety and depression scores [ Time Frame: first visit (day 1) to each of the 5 follow-up questionnaires (~day 2, 8, 15, 21 & 28) ]
  3. Proportion of infants achieving clinically-relevant reduction in crying time [ Time Frame: From baseline to day 21 and day 28 follow ups ]
  4. Proportion of infants reported with absence of 'colic' [ Time Frame: At day 21 and day 28 (final 2 follow-ups) ]
  5. Parental Global Impressions of Change in symptoms [ Time Frame: At each of the follow-up questionanaires (~day 2, 8, 15, 21 and 28) ]
  6. Cost of NHS resources used [ Time Frame: Reported 'during the preceding week' at each telephone questionnaire (~day 2, 8, 15, 21 and 28) ]
    Costs calculated based on reported interactions and standard costs published annually by the Personal Social Services Research Unit (PSSRU) in the UK.

  7. Change to Severity of colic-related specific symptoms [ Time Frame: Baseline to day after first, mid point and final clinic visits (~days 2, 8, 15) then to day 21 and day 28 ]
    Based on 5-point likert scale 'not at all' to 'a very great deal' for crying with high pitched sound, crying with pain cry, pulling faces (apparently in pain), having a flushed face, holding breath, clenching fists, bending elbows/holding arms rigid, punching fists, wind milling arms, kicking legs, drawing legs up, arching back, tense/distended abdomen, borborygmus, flatulence, vomiting/regurgitating

  8. Change to Parental Global Impressions of Severity [ Time Frame: Baseline to follow-ups after first second and final clinic visits (~days 2, 8, 15) then to day 21 and day 28 follow ups ]
  9. Effectiveness of Blinding [ Time Frame: 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) ]
    Proportion of correct, incorrect and 'don't know' guesses, reported using James' and Bangs' blinding indices



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138656


Locations
Layout table for location information
United Kingdom
University of Southampton
Southampton, Hampshire, United Kingdom
Sponsors and Collaborators
University of Southampton
McTimoney College of Chiropractic
Investigators
Layout table for investigator information
Principal Investigator: George Lewith University of Southampton
Layout table for additonal information
Responsible Party: University of Southampton
ClinicalTrials.gov Identifier: NCT02138656    
Other Study ID Numbers: ERGO 4866
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017
Keywords provided by University of Southampton:
Crying
Chiropractic
Infant
pediatric
Infantile colic
Clinical Trial
Additional relevant MeSH terms:
Layout table for MeSH terms
Colic
Infant, Newborn, Diseases