The Effect of Chiropractic Treatment of Infantile Colic
The Effect of Chiropractic Treatment of Infantile Colic
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.
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.
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