Infant ConditionsNCT03675763
Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
A study testing Manual treatment in people with Infant Conditions and Colic, Infantile, run by Universidad Católica San Antonio de Murcia.
Trial summary
This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment. Read more about this study
- Who is it for?
- Ages 0 to 90 days
- Conditions the study is for
- Infant Conditions, Colic, Infantile, Gastro-Intestinal Disorder
- What is being tested?
- Manual treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- 2 Mar 2015to 30 Dec 2016
- 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 0 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- infants diagnosed with colic,
- with 0-90 days of age,
- who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study.
Who cannot join
- infants diagnosed with any sort of pathological illness, allergies or food intolerance
- who have suffered any intracranial hemorrhages or skull fractures.
About this study
This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.
- Being tested
- Manual treatment
- Keywords
- Skull, Osteopathic Manipulation, Infantile Colic, Clinical Trial, Massage, Infant, Osteopathic Medicine
- Medical subject headings
- Colic, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual treatmentOther
Craniosacral therapy protocol.
| Study group | Role | What they receive |
|---|---|---|
| Craniosacral therapy | Experimental | Craniosacral therapy and parent information on how to manage colic. Receives: Other: Manual treatment |
| Parent information | No intervention | Parent information on how to manage colic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying
Total amount of time the infant cries within a day. Crying is recorded by the parents in a diary. The higher the score is, the more hours of crying per day.
Measured: Change from baseline crying at 24 days, also evaluated at days 7 and 14
Secondary outcomes (2)
Sleep
Total amount of time the infant sleeps within a day. Sleep is recorded by the parents in a diary. The higher the score is, the more hours of sleep per day.
Measured: Change from baseline sleep at 24 days, also evaluated at days 7 and 14
Severity-ICSQ
Severity of colic is measured according to a validated Infant Colic Severity Questionnaire. Minimum score is 24 and maximum 100. A score higher than 50 points suggests that the patient suffers from infantile colic.
Measured: Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start2 Mar 2015
- Primary completion20 Dec 2016
- Study completion30 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ConditionsStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica San Antonio de Murcia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mercedes Castejón Castejón, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03675763
- Sponsor's protocol ID
- 77712133D
- Status last verified
- Jan 2022
- First submitted
- 15 Sep 2018
- Last updated
- 4 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Craniosacral Therapy Protocol in the Treatment of Infant Colic
- ClinicalTrials.gov ID
- NCT03675763
- Acronym / sponsor ID
- 77712133D
- Keywords
- Skull, Osteopathic Manipulation, Infantile Colic, Clinical Trial, Massage, Infant, Osteopathic Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Universidad Católica San Antonio de MurciaUniversity, hospital or other
- Study start
- 2 Mar 2015 (actual)
- Primary completion
- 20 Dec 2016 (actual)
- Study completion
- 30 Dec 2016 (actual)
- First posted
- 18 Sep 2018 (actual)
- 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.
This is a randomised controlled trial that aims to determine the effectiveness of craniosacral therapy for the treatment of infantile colic. Manual therapy was applied to a group of young infants diagnosed with colic while a second group did not received any treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Craniosacral therapy | Experimental | Other: Manual treatmentCraniosacral therapy and parent information on how to manage colic. |
| Parent information | No intervention | –Parent information on how to manage colic. |
Who may qualify
- Ages
- 0 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- infants diagnosed with colic,
- with 0-90 days of age,
- who have had 3 hours of unexplainable crying per day for at least 3 days during the week previous to the study.
Key exclusion criteria (2 listed)
- infants diagnosed with any sort of pathological illness, allergies or food intolerance
- who have suffered any intracranial hemorrhages or skull fractures.
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 |
|---|---|---|
| Manual treatmentCraniosacral therapy protocol. | Other | Craniosacral therapy |
Primary outcome
Crying
Time frame: Change from baseline crying at 24 days, also evaluated at days 7 and 14
Total amount of time the infant cries within a day. Crying is recorded by the parents in a diary. The higher the score is, the more hours of crying per day.
2 secondary outcomes
Sleep
Time frame: Change from baseline sleep at 24 days, also evaluated at days 7 and 14
Severity-ICSQ
Time frame: Change from baseline severity -ICSQ at 24 days, also evaluated at days 7 and 14
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 4 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Infant Conditions
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Duramesh Versus Minimally Invasive IPOM for High-Risk Umbilical Hernia Repairs
Umbilical Hernia, Ventral Hernia
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Manual treatment in people with Infant Conditions and Colic, Infantile, run by Universidad Católica San Antonio de Murcia.
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 2 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Crying (time frame: Change from baseline crying at 24 days, also evaluated at days 7 and 14). 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 4 Feb 2022.