Infantile ColicNCT00954759
The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial
A study testing Chiropractic treatment and Visit without active treatment in people with Infantile Colic, run by Nordic Institute of Chiropractic and Clinical Biomechanics at 1 site in Denmark.
Trial summary
Infantile colic is a condition that affects more than 10% of babies and their families. The reason, and hence the proper treatment, for this condition is unknown and many causes have been suggested. One of the treatments that parents choose is chiropractic manipulation. Read more about this study
- Who is it for?
- Ages 2 to 10 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Chiropractic treatment and Visit without active treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-10 weeks.
- Minimum crying and fussing: three hours per day, three days per week.
Who cannot join
- Known disease.
- Unsatisfying weight gain.
- Psychological or developmental compromise.
- Contraindications for chiropractic treatment.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Nordic Institute of Chiropractic and Clinical Biomechanics
Odense, DK, 5230
About this study
Infantile colic is a condition that affects more than 10% of babies and their families. The reason, and hence the 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, around 4,000 babies are treated for colic by chiropractors each year although the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.
The effect 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'.
Read more
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.
The results from subgroup analyses can help to identify children who might benefit from the treatment. Then treatment can be initiated early and a lot of hardship can be avoided for both the babies and the families.
Read the detailed description
OBJECTIVES:
Primary: To investigate the effect of chiropractic treatment on infantile colic.
Secondary: A) To investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without. B) To investigate whether health visitors and chiropractors can agree on the diagnosis of "suspected musculoskeletal problems".
METHOD:
A randomized controlled single blind multicenter clinical trial with a nested case-crossover study.
Infants fulfilling the diagnostic criteria for colic will be recruited by health visitors and randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children will be taken to the chiropractors' treatment room while the parents stay in the reception areas. Before treatment, both the recruiting health visitors and the chiropractors will note, whether they suspect musculoskeletal involvement or not. All analyses will be adjusted for known confounders, which will be recorded by the health visitor at baseline.
PERSPECTIVE FOR HEALTH CARE:
First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differ between children with suspected musculoskeletal problems and those without. If children with musculoskeletal problems respond better to chiropractic treatment than others, the study will also indicate whether the health nurse is able to identify these children.
- Conditions
- Infantile Colic
- Being tested
- Chiropractic treatment, Visit without active treatment
- Keywords
- Infantile colic, Chiropractic, Manipulation, Randomized controlled trial
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic treatmentProcedure or surgery
Also called Manipulation, mobilisation
Visit without active treatmentProcedure or surgery
The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic treatment | Experimental | Manipulation and/or mobilisation Receives: Procedure: Chiropractic treatment |
| Visit without active treatment | Placebo comparator | The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not. Receives: Procedure: Visit without active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in hours of crying
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionAug 2012
- Study completionAug 2012
Why it stopped: Abandoned due to poor recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical Biomechanics
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for the Advancement of Chiropractic Research, University of Southern Denmark
- Investigators
- Lise Hestbaek, PhD, Study director, Nordic Institute of Chiropractic and Clinical Biomechanics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954759
- Sponsor's protocol ID
- RCT Colic
- Other IDs
- CVK S-20090056
- Status last verified
- Nov 2012
- First submitted
- 6 Aug 2009
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chiropractic Treatment on Infantile Colic A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00954759
- Acronym / sponsor ID
- RCT Colic
- Conditions
- Infantile Colic
- Keywords
- Infantile colic, Chiropractic, Manipulation, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Abandoned due to poor recruitment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical BiomechanicsUniversity, hospital or other
- Collaborators
- Foundation for the Advancement of Chiropractic Research, University of Southern Denmark
- Study start
- Sep 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 7 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Infantile colic is a condition that affects more than 10% of babies and their families. The reason, and hence the 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, around 4,000 babies are treated for colic by chiropractors each year although the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.
The effect 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.
The results from subgroup analyses can help to identify children who might benefit from the treatment. Then treatment can be initiated early and a lot of hardship can be avoided for both the babies and the families.
Detailed description
OBJECTIVES:
Primary: To investigate the effect of chiropractic treatment on infantile colic.
Secondary: A) To investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without. B) To investigate whether health visitors and chiropractors can agree on the diagnosis of "suspected musculoskeletal problems".
METHOD:
A randomized controlled single blind multicenter clinical trial with a nested case-crossover study.
Infants fulfilling the diagnostic criteria for colic will be recruited by health visitors and randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children will be taken to the chiropractors' treatment room while the parents stay in the reception areas. Before treatment, both the recruiting health visitors and the chiropractors will note, whether they suspect musculoskeletal involvement or not. All analyses will be adjusted for known confounders, which will be recorded by the health visitor at baseline.
PERSPECTIVE FOR HEALTH CARE:
First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differ between children with suspected musculoskeletal problems and those without. If children with musculoskeletal problems respond better to chiropractic treatment than others, the study will also indicate whether the health nurse is able to identify these children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiropractic treatment | Experimental | Procedure: Chiropractic treatmentManipulation and/or mobilisation |
| Visit without active treatment | Placebo comparator | Procedure: Visit without active treatmentThe child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not. |
Who may qualify
- Ages
- 2 to 10 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Age: 2-10 weeks.
- Minimum crying and fussing: three hours per day, three days per week.
Key exclusion criteria (4 listed)
- Known disease.
- Unsatisfying weight gain.
- Psychological or developmental compromise.
- Contraindications for chiropractic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiropractic treatmentAlso: Manipulation, mobilisation | Procedure or surgery | Chiropractic treatment |
| Visit without active treatmentThe child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether treatment is delivered or not. | Procedure or surgery | Visit without active treatment |
Primary outcome
Decrease in hours of crying
Time frame: Two weeks
Results and safety
The study was stopped early (reason given: Abandoned due to poor recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lise Hestbaek, PhD study director
Nordic Institute of Chiropractic and Clinical Biomechanics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiropractic treatment and Visit without active treatment in people with Infantile Colic, run by Nordic Institute of Chiropractic and Clinical Biomechanics at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Abandoned due to poor recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decrease in hours of crying (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.