The Effect of Chiropractic Treatment of Infantile Colic

NCT02595515 | Completed

• 1 other identifier: -14/1206
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infantile Colic

Outcome Measures

Primary Outcomes (1)

• Change in hours of crying

  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 Outcomes (1)

• Change in hours of crying for children with suspected musculo-skeletal problems

  Two weeks

Study Arms (2)

Chiropractic treatment

EXPERIMENTAL

Manipulation and/or mobilisation. Intervention: Procedure: Chiropractic treatment.

Other: Chiropractic treatment

Visit without active treatment

PLACEBO COMPARATOR

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

Interventions

Chiropractic treatment OTHER

Procedure: chiropractic treatment.

Also known as: Manipulation, mobilisation

Chiropractic treatment

Visit without active treatment OTHER

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.

Visit without active treatment

Eligibility Criteria

• Age: 2 Weeks - 14 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nordic Institute of Chiropractic and Clinical Biomechanics: lead
• Research Unit of General Practice, Odense: collaborator

Study Sites (1)

University of Southern Denmark

Odense, 5230, Denmark

Location

Related Publications (3)

• Holm LV, Vach W, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial. Chiropr Man Therap. 2021 Apr 19;29(1):16. doi: 10.1186/s12998-021-00373-6.

  PMID: 33874964 DERIVED

• Holm LV, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial. Chiropr Man Therap. 2021 Apr 19;29(1):15. doi: 10.1186/s12998-021-00371-8.

  PMID: 33874955 DERIVED

• Holm LV, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial. Chiropr Man Therap. 2018 Jun 7;26:17. doi: 10.1186/s12998-018-0188-9. eCollection 2018.

  PMID: 29930798 DERIVED

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Lise V Holm, MD, PhD

  Research Unit of General Practice, Odense, University of Southern Denmark, JB Wilsløwsvej 9A, 5000 Odense C, Denmark

  PRINCIPAL INVESTIGATOR

• Lise Hestbæk, Assoc Prof

  Nordic Institute of Chiropractic and Clinical Biomechanics. Campusvej 55, 5250 Odense M, DK, Denmark

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 2, 2015
• First Posted: November 3, 2015
• Study Start: November 1, 2015
• Primary Completion: June 1, 2019
• Study Completion: June 1, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Locations

DK (1)