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CHiropractic for Infantile Colic Study

NCT02138656 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2021-04-26

No results posted yet for this study

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.

Conditions

  • Infantile Colic

Interventions

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

Sponsors & Collaborators

  • McTimoney College of Chiropractic

    collaborator UNKNOWN

  • University of Southampton

    lead OTHER

Principal Investigators

  • George Lewith · University of Southampton

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
1 Day
Max Age
12 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02138656 on ClinicalTrials.gov