Infantile ColicNCT02595515
The Effect of Chiropractic Treatment of Infantile Colic
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 condition that affects more than 10% of babies and their families. The reason, and hence 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 14 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Chiropractic treatment and Visit without active treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2015to Jun 2019
- 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 14 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 2-14 weeks.
- Minimum crying and fussing: three hours per day, three days per week
- Satisfying weight gain
Who cannot join
- Known disease
- Symptoms than can indicate other condition than infantile colic
- Contraindications for chiropractic treatment
- Previous chiropractic treatment due to infantile colic
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chiropractic Treatment of Infantile Colic. A Randomized, Controlled Trial
Infantile colic is condition that affects more than 10% of babies and their families. The reason, and hence 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, almost 10,000 babies are each year treated by chiropractors, and a high proportion is due to colic. However, the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.
The effects 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.
Read the detailed description
OBJECTIVES:
Primary: To investigate the effect of chiropractic treatment on infantile colic
Secondary: to investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without.
METHOD:
A randomized controlled single blind multicenter clinical trial
The project is to be carried out on the island of Funen, Denmark. Recruitment of babies with symptoms of infantile colic is based on contact by the parents of the babies to the project manager. Information about the existence of the study is given to health visitors, general practitioners, midwifes and to women who have given birth on the maternity ward in the University Hospital of Odense. For infants fulfilling the diagnostic criteria for colic the parents will register amount of crying using a valid instrument for at least three days before the first visit at the chiropractor Clinic (baseline registration). The babies will be randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children have four visits during two weeks at the chiropractor. All children will be taken to the chiropractor's treatment room, while the parents stay in the reception areas. Before treatment, the chiropractors will note, whether they suspect musculoskeletal involvement or not. The parents register the amount of crying continuously during the two weeks and up to and including three days after the fourth visit. Three days after the the fourth visit, the parents are informed by the chiropractor about the child's allocation. Children in the control group will afterwards have the opportunity to have four free visits with chiropractic treatment.
The parents will be asked to give consent that the medical journal regarding pregnancy and birth is reviewed in order to obtain information on specific measures (e.g. duration of pregnancy, duration of labor, delivery presentation, vacuum extractor delivery or caesarean section). Subgroup analyses will be performed to investigate associations with symptoms of colic and suspected musculoskeletal involvement. All analyses will be adjusted for known confounders, registered by the project manager at baseline.
PERSPECTIVE FOR HEALTHCARE:
First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differs between children with suspected musculoskeletal involvement and those without.
- Conditions
- Infantile Colic
- Being tested
- Chiropractic treatment, Visit without active treatment
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiropractic treatmentOther
Also called Manipulation, mobilisation
Procedure: chiropractic treatment.
Visit without active treatmentOther
Procedure: Visit without active treatment. The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not.
| Study group | Role | What they receive |
|---|---|---|
| Chiropractic treatment | Experimental | Manipulation and/or mobilisation. Intervention: Procedure: Chiropractic treatment. Receives: Other: 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 the treatment is delivered or not. Receives: Other: Visit without active treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hours of crying
Change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children
Measured: Two weeks
Secondary outcomes (1)
Change in hours of crying for children with suspected musculo-skeletal problems
Subgroup analysis for the children with suspected musculo-skeletal problems including change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children
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 posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical Biomechanics
- Sponsor type
- University, hospital or other
- Collaborators
- Research Unit of General Practice, Odense
- Responsible party
- Sponsor
- Investigators
- Lise V Holm, MD, PhD, Principal investigator, Research Unit of General Practice, Odense, University of Southern Denmark, JB Wilsløwsvej 9A, 5000 Odense C, DenmarkLise Hestbæk, Assoc Prof, Study director, Nordic Institute of Chiropractic and Clinical Biomechanics. Campusvej 55, 5250 Odense M, DK, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595515
- Sponsor's protocol ID
- -14/1206
- Status last verified
- Aug 2019
- First submitted
- 2 Nov 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Holm LV, Vach W, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial. Chiropr Man Therap. 2021 Apr 19;29(1):16. doi: 10.1186/s12998-021-00373-6.
PubMed 33874964Holm LV, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial. Chiropr Man Therap. 2021 Apr 19;29(1):15. doi: 10.1186/s12998-021-00371-8.
PubMed 33874955Holm LV, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial. Chiropr Man Therap. 2018 Jun 7;26:17. doi: 10.1186/s12998-018-0188-9. eCollection 2018.
PubMed 29930798
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chiropractic Treatment of Infantile Colic. A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02595515
- Acronym / sponsor ID
- -14/1206
- Conditions
- Infantile Colic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Nordic Institute of Chiropractic and Clinical BiomechanicsUniversity, hospital or other
- Collaborators
- Research Unit of General Practice, Odense
- Study start
- Nov 2015
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 3 Nov 2015 (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 condition that affects more than 10% of babies and their families. The reason, and hence 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, almost 10,000 babies are each year treated by chiropractors, and a high proportion is due to colic. However, the effect of chiropractic treatment of infantile colic has not been properly scientifically evaluated.
The effects 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.
Detailed description
OBJECTIVES:
Primary: To investigate the effect of chiropractic treatment on infantile colic
Secondary: to investigate if infants with suspected musculoskeletal problems respond differently to the treatment than those without.
METHOD:
A randomized controlled single blind multicenter clinical trial
The project is to be carried out on the island of Funen, Denmark. Recruitment of babies with symptoms of infantile colic is based on contact by the parents of the babies to the project manager. Information about the existence of the study is given to health visitors, general practitioners, midwifes and to women who have given birth on the maternity ward in the University Hospital of Odense. For infants fulfilling the diagnostic criteria for colic the parents will register amount of crying using a valid instrument for at least three days before the first visit at the chiropractor Clinic (baseline registration). The babies will be randomized to chiropractic treatment or no treatment. The parents will be unaware of the child's allocation. All children have four visits during two weeks at the chiropractor. All children will be taken to the chiropractor's treatment room, while the parents stay in the reception areas. Before treatment, the chiropractors will note, whether they suspect musculoskeletal involvement or not. The parents register the amount of crying continuously during the two weeks and up to and including three days after the fourth visit. Three days after the the fourth visit, the parents are informed by the chiropractor about the child's allocation. Children in the control group will afterwards have the opportunity to have four free visits with chiropractic treatment.
The parents will be asked to give consent that the medical journal regarding pregnancy and birth is reviewed in order to obtain information on specific measures (e.g. duration of pregnancy, duration of labor, delivery presentation, vacuum extractor delivery or caesarean section). Subgroup analyses will be performed to investigate associations with symptoms of colic and suspected musculoskeletal involvement. All analyses will be adjusted for known confounders, registered by the project manager at baseline.
PERSPECTIVE FOR HEALTHCARE:
First of all, the study will evaluate the effect of chiropractic treatment of infantile colic. Secondly, it will clarify if the treatment effect differs between children with suspected musculoskeletal involvement and those without.
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 | Other: Chiropractic treatmentManipulation and/or mobilisation. Intervention: Procedure: Chiropractic treatment. |
| Visit without active treatment | Placebo comparator | Other: Visit without active treatmentThe child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not. |
Who may qualify
- Ages
- 2 to 14 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age: 2-14 weeks.
- Minimum crying and fussing: three hours per day, three days per week
- Satisfying weight gain
Key exclusion criteria (4 listed)
- Known disease
- Symptoms than can indicate other condition than infantile colic
- Contraindications for chiropractic treatment
- Previous chiropractic treatment due to infantile colic
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, mobilisationProcedure: chiropractic treatment. | Other | Chiropractic treatment |
| Visit without active treatmentProcedure: Visit without active treatment. The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not. | Other | Visit without active treatment |
Primary outcome
Change in hours of crying
Time frame: Two weeks
Change in number of crying hours per day based on parental diaries (before and after treatment) when comparing treated and not treated children
1 secondary outcome
Change in hours of crying for children with suspected musculo-skeletal problems
Time frame: Two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Derived from this study: PubMed 33874964Holm LV, Vach W, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. Identifying potential treatment effect modifiers of the effectiveness of chiropractic care to infants with colic through prespecified secondary analyses of a randomised controlled trial. Chiropr Man Therap. 2021 Apr 19;29(1):16. doi: 10.1186/s12998-021-00373-6.
- Derived from this study: PubMed 33874955Holm LV, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. The effect of chiropractic care on infantile colic: results from a single-blind randomised controlled trial. Chiropr Man Therap. 2021 Apr 19;29(1):15. doi: 10.1186/s12998-021-00371-8.
- Derived from this study: PubMed 29930798Holm LV, Jarbol DE, Christensen HW, Sondergaard J, Hestbaek L. The effect of chiropractic treatment on infantile colic: study protocol for a single-blind randomized controlled trial. Chiropr Man Therap. 2018 Jun 7;26:17. doi: 10.1186/s12998-018-0188-9. eCollection 2018.
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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 V Holm, MD, PhD principal investigator
Research Unit of General Practice, Odense, University of Southern Denmark, JB Wilsløwsvej 9A, 5000 Odense C, Denmark
Lise Hestbæk, Assoc Prof study director
Nordic Institute of Chiropractic and Clinical Biomechanics. Campusvej 55, 5250 Odense M, DK, Denmark
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 3 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: finished, as of the sponsor's last update on 28 Aug 2019. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change 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?
On the ClinicalTrials.gov record for NCT02595515, which also lists 3 linked publications.
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 28 Aug 2019.