Condition category
Neonatal Diseases
Date applied
29/01/2007
Date assigned
09/10/2007
Last edited
10/10/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dut.ac.za/front%20page.aspx

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

Publication citations

Additional files

Editorial Notes