CHiropractic for Infantile Colic Study

NCT02138656 | Terminated DMC

• 1 other identifier: ERGO 4866
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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:

• 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?
• 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.

Conditions

Infantile Colic

Keywords

Crying; Chiropractic; Infant; pediatric; Infantile colic; Clinical Trial

Outcome Measures

Primary Outcomes (4)

• Changes to the duration of crying per day

  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

  Defined as 60 minutes (median) based on survey

  Baseline to day after first clinic visit (~day 2), mid point (~day 8) and final clinic visit (~day 15)

• Proportion of infants reported with absence of 'colic'

  Taken from the Parental Global Impression of Severity scale

  Follow-up telephone call after first, mid point and final clinic visit (approx days 2, 8 and 15)

• Number of adverse events

  at any time during an infant's engagement in the study, circa 28 days

Secondary Outcomes (9)

• Changes to the duration of crying per day

  baseline to day 21 and day 28

• 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)

• 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)

• Parental Global Impressions of Change in symptoms

  At each of the follow-up questionanaires (~day 2, 8, 15, 21 and 28)

Study Arms (4)

Best standard care only - not blind

ACTIVE COMPARATOR

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

Best Standard Care and Sham - Blind

SHAM COMPARATOR

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

BSC & Chiropractic - Not blind

EXPERIMENTAL

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; Other: Best Standard Care

BSC & Chiropractic - Blind

EXPERIMENTAL

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; Other: Best Standard Care

Interventions

Chiropractic OTHER

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

BSC & Chiropractic - Blind; BSC & Chiropractic - Not blind

Best Standard Care OTHER

Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic

BSC & Chiropractic - Blind; BSC & Chiropractic - Not blind; Best Standard Care and Sham - Blind; Best standard care only - not blind

Eligibility Criteria

• Age: 1 Day - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Infants who have received previous chiropractic, osteopathic or other manipulative treatment

Sponsors & Collaborators

• University of Southampton: lead
• McTimoney College of Chiropractic: collaborator

Study Sites (1)

University of Southampton

Southampton, Hampshire, United Kingdom

Location

MeSH Terms

Conditions

Colic; Crying

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nonverbal Communication; Communication; Behavior

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• George Lewith

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 14, 2014
• Study Start: March 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 26, 2021

Record last verified: 2021-04

Locations

GB (1)