The Effect of Chiropractic Treatment of Infantile Colic

August 27, 2019 updated by: Nordic Institute of Chiropractic and Clinical Biomechanics

The Effect of Chiropractic Treatment of Infantile Colic. A Randomized, Controlled Trial

Infantile colic is condition that affects more than 10% of babies and their families. The reason, and hence proper treatment, for this condition is unknown and many causes have been suggested. One of the treatments that parents choose is chiropractic manipulation. In Denmark, almost 10,000 babies are each year treated by chiropractors, and a high proportion is due to colic. However, the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.

The effects of chiropractic treatment on infantile colic needs to be investigated, since this is a very common disorder with no known effective treatment, but with good empirical evidence of the value of chiropractic treatment. Although it is usually considered to be a benign and self-limiting condition, some studies suggest there might be long-term effects in terms of psychomotor problems. In worst case, the infants' crying may also lead to violence and 'shaken baby syndrome'.

Null hypothesis: There is no effect of chiropractic treatment on the course of infantile colic.

This study is a controlled, clinical trial where infants fulfilling the diagnostic criteria for colic will be randomized into two groups. One group will receive treatment and the other won't. This will determine the overall effect and furthermore, subgroup analyses will be performed to identify possible subgroups of infants, who will benefit the most from the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary: To investigate the effect of chiropractic treatment on infantile colic

Secondary: to investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without.

METHOD:

A randomized controlled single blind multicenter clinical trial

The project is to be carried out on the island of Funen, Denmark. Recruitment of babies with symptoms of infantile colic is based on contact by the parents of the babies to the project manager. Information about the existence of the study is given to health visitors, general practitioners, midwifes and to women who have given birth on the maternity ward in the University Hospital of Odense. For infants fulfilling the diagnostic criteria for colic the parents will register amount of crying using a valid instrument for at least three days before the first visit at the chiropractor Clinic (baseline registration). The babies will be randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children have four visits during two weeks at the chiropractor. All children will be taken to the chiropractor's treatment room, while the parents stay in the reception areas. Before treatment, the chiropractors will note, whether they suspect musculoskeletal involvement or not. The parents register the amount of crying continuously during the two weeks and up to and including three days after the fourth visit. Three days after the the fourth visit, the parents are informed by the chiropractor about the child's allocation. Children in the control group will afterwards have the opportunity to have four free visits with chiropractic treatment.

The parents will be asked to give consent that the medical journal regarding pregnancy and birth is reviewed in order to obtain information on specific measures (e.g. duration of pregnancy, duration of labor, delivery presentation, vacuum extractor delivery or caesarean section). Subgroup analyses will be performed to investigate associations with symptoms of colic and suspected musculoskeletal involvement. All analyses will be adjusted for known confounders, registered by the project manager at baseline.

PERSPECTIVE FOR HEALTHCARE:

First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differs between children with suspected musculoskeletal involvement and those without.

Study Type

Interventional

Enrollment (Actual)

186

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5230
        • University of Southern Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 weeks to 3 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 2-14 weeks.
  • Minimum crying and fussing: three hours per day, three days per week
  • Satisfying weight gain

Exclusion Criteria:

  • Known disease
  • Symptoms than can indicate other condition than infantile colic
  • Contraindications for chiropractic treatment
  • Previous chiropractic treatment due to infantile colic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Chiropractic treatment
Manipulation and/or mobilisation. Intervention: Procedure: Chiropractic treatment.
Other: Chiropractic treatment
Procedure: chiropractic treatment.
Other Names:
  • Manipulation
  • mobilisation
PLACEBO_COMPARATOR: Visit without active treatment
The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not.
Other: Visit without active treatment
Procedure: Visit without active treatment. The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hours of crying
Time Frame: Two weeks
Change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children
Two weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hours of crying for children with suspected musculo-skeletal problems
Time Frame: Two weeks
Subgroup analysis for the children with suspected musculo-skeletal problems including change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nordic Institute of Chiropractic and Clinical Biomechanics

Collaborators

Research Unit of General Practice, Odense

Investigators

  • Principal Investigator: Lise V Holm, MD, PhD, Research Unit of General Practice, Odense, University of Southern Denmark, JB Wilsløwsvej 9A, 5000 Odense C, Denmark
  • Study Director: Lise Hestbæk, Assoc Prof, Nordic Institute of Chiropractic and Clinical Biomechanics. Campusvej 55, 5250 Odense M, DK, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

November 2, 2015

First Submitted That Met QC Criteria

November 2, 2015

First Posted (ESTIMATE)

November 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • -14/1206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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