The Effect of Chiropractic Treatment of Infantile Colic
Condition: Infantile Colic
MeSH terms: Colic
Study type: Interventional

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.
    

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.
    

Intervention name(s): Chiropractic treatment; Visit without active treatment
Intervention type(s): Other; Other
Intervention description(s): Procedure: chiropractic 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.
Other intervention name(s): Manipulation; mobilisation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment