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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Murdoch University
School of Chiropractic
Room ECL 1.009
South Street
Murdoch
6150
Australia
| Phone | +61 08 9360 7690 |
|---|---|
| b.nook@murdoch.edu.au |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/01/1998 |
| Completion date | 01/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
6150
Australia
Sponsor information
Technikon Natal School of Chiropractic (South Africa)
University/education
University/education
Durban University Of Technology - Durban Central Offices
41/43 Centenary Road
Durban
4001
South Africa
| Phone | +27 (0)31 308 5111 |
|---|---|
| CharmaK@dut.ac.za | |
| Website | http://www.dut.ac.za/front%20page.aspx |
"ROR" |
https://ror.org/0303y7a51 |
Funders
Funder type
University/education
Technikon Natal School of Chiropractic (South Africa)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
