The efficacy of chiropractic spinal adjustments as a treatment protocol in the management of infantile colic: a randomised controlled trial

ISRCTN	ISRCTN68305337
DOI	https://doi.org/10.1186/ISRCTN68305337
Protocol serial number	N/A
Sponsor	Technikon Natal School of Chiropractic (South Africa)
Funder	Technikon Natal School of Chiropractic (South Africa)

Submission date: 29/01/2007
Registration date: 09/10/2007
Last edited: 10/10/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Neonatal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Brian Nook
Scientific

Murdoch University
School of Chiropractic
Room ECL 1.009
South Street
Murdoch
6150
Australia

Phone	+61 08 9360 7690
Email	b.nook@murdoch.edu.au

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Chiropractic manipulation is more effective than placebo for the treatment of infantile colic.
Ethics approval(s)	Responsible Committee on Human Experimentation, and the Research Ethics Committee of Technikon Natal, Durban, South Africa. Approved in 1998.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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?
Key secondary outcome measure(s)	Increased joint motion assessed at baseline, each subsequent treatment session and follow-up consultation.
Completion date	01/12/1998

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	30
Key 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
Key exclusion criteria	Any participant that did not meet the inclusion criteria.
Date of first enrolment	01/01/1998
Date of final enrolment	01/12/1998

Locations

Countries of recruitment

Australia
South Africa

Study participating centre

Murdoch University

Murdoch
6150
Australia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan