Contact information
Type
Scientific
Primary contact
Dr Brian Nook
ORCID ID
Contact details
Murdoch University
School of Chiropractic
Room ECL 1.009
South Street
Murdoch
6150
Australia
+61 08 9360 7690
b.nook@murdoch.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Chiropractic manipulation is more effective than placebo for the treatment of infantile colic.
Ethics approval
Responsible Committee on Human Experimentation, and the Research Ethics Committee of Technikon Natal, Durban, South Africa. Approved in 1998.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Infantile colic
Intervention
Chiropractic manipulation/mobilization for spinal adjustments vs placebo treatment. One hour per session, 6 sessions over a 2-week period with a follow-up consultation after 1 month.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Parental questionnaire at baseline, each subsequent treatment session and follow-up consultation. The questionnaire asked the following quetisons:
1. Measured from the parents' perception, how long does the baby cry with each attack of colic?
2. How often does the colic occur in 24 hours?
3. Does the colic attack occur at any particular time of day or night?
4. Does anything seem to precipitate an attack?
5. For how long does the baby sleep between colic attacks?
6. Does the baby still require medicine to relieve the colic?
7. How would you rate the baby's response to treatment (1-5)?
8. Has the baby had any other illnesses?
Secondary outcome measures
Increased joint motion assessed at baseline, each subsequent treatment session and follow-up consultation.
Overall trial start date
01/01/1998
Overall trial end date
01/12/1998
Reason abandoned
Eligibility
Participant inclusion criteria
1. The infant was to undergo a thorough examination by the consulting paediatrician to determine the health of the infant and to exclude any underlying organic problem, thereby ensuring a strict diagnosis of infantile colic
2. The infant was to be 0 to 8 weeks of age at the commencement of treatment to exclude the possibility of spontaneous cessation of the colic at 3 months
3. Apart from the colic, the infant was to suffer from no other condition/disease
4. If any medication had been administered to the infant to relieve the symptomatology of colic prior to the commencement of treatment (whether prescribed or over-the-counter drugs) the infant was required to remain on the same medication for the duration of the study, if the medication was required
5. Written informed consent was to be obtained from a parent before participation in the study
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
30
Participant exclusion criteria
Any participant that did not meet the inclusion criteria.
Recruitment start date
01/01/1998
Recruitment end date
01/12/1998
Locations
Countries of recruitment
South Africa
Trial participating centre
Murdoch University
Murdoch
6150
Australia
Sponsor information
Organisation
Technikon Natal School of Chiropractic (South Africa)
Sponsor details
Durban University Of Technology - Durban Central Offices
41/43 Centenary Road
Durban
4001
South Africa
+27 (0)31 308 5111
CharmaK@dut.ac.za
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Technikon Natal School of Chiropractic (South Africa)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary