Colic, InfantileNCT04841590
Effects of Osteopathic Manual Therapy on Infant Colic
A study testing Intervention of the experimental group (EG) in people with Colic, Infantile, run by University of Seville at 3 sites in Spain.
Trial summary
Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to… Read more about this study
- Who is it for?
- Ages 2 to 12 weeks
- Conditions the study is for
- Colic, Infantile
- What is being tested?
- Intervention of the experimental group (EG)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Apr 2021to 30 Dec 2024
- 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 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks.
- Age 2 - 12 weeks.
- Gestation equal to or greater than 38 weeks.
- Birth weight equal to or greater than 2,500 grams.
- Weight gain of at least 150 grams. per week.
- Appropriate pediatric general physical examination (height, weight, head circumference and psychomotor development).
- Sign the informed consent.
Who cannot join
- Signs and / or symptoms of other pathologies.
- Signs of lactose intolerance.
- Having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein.
- Having received the subjects and / or siblings, previous treatment with Osteopathy and / or Chiropractic.
- Contraindication to the treatment and / or some of its techniques; presence of congenital malformations.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Clinica de Fisioterapia y Osteopatía M4
Granada, Granada, 18003
Hospital del Sureste
Madrid, Madrid, 28500
Fisioterapia y Osteopatía David Nuñez
Madrid, Madrid, 28514
About this study
Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to CL treatment.
The main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of CL, the frequency of episodes, changes in stool and possible adverse effects.
Read more
The study hypothesis argues that the application of osteopathic manual therapy in babies with CL produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. A controlled RCT will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (EG) and control group (CG) using a table of random numbers by a person from outside the research. The EG diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. The CG has no treatment.
A total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required).
The therapist in charge of performing the operations will be a Physiotherapist and Osteopath with more than 10 years of experience.
The evaluations will be carried out by a healthcare professional with more than 10 years of experience. The evaluator will be blinded. Parents blinded with respect to the allocation group of each subject until the end of the study.
To analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. The Infantile Colic Severity Questionnaire (ICSQ) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).
- Conditions
- Colic, Infantile
- Being tested
- Intervention of the experimental group (EG), Control Group (CG)
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention of the experimental group (EG)Other
Treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests.
Control Group (CG)Other
Subjects in the control group (CG) will not receive any treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | The experimental group (EG) will receive treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests. Receives: Other: Intervention of the experimental group (EG) |
| Control Group | Sham comparator | The control group (CG) will not receive any treatment Receives: Other: Control Group (CG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hours of crying per day
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Measured: At the beginning of the study (pre-intervention)
Total hours of crying per day
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Measured: 1 week after the first intervention
Total hours of crying per day
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Measured: 2 weeks after the first intervention
Total hours of crying per day
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Measured: 3 weeks after the first intervention
Total hours of crying per day
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Measured: Finally at 4 weeks from the first intervention
Frequency of episodes
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Measured: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Frequency of episodes
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Measured: 1 week after the first intervention
Frequency of episodes
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Measured: 2 weeks after the first intervention
Frequency of episodes
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Measured: 3 weeks after the first intervention
Frequency of episodes
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Measured: Finally at 4 weeks from the first intervention
Secondary outcomes (4)
Colic Severity
Severity will be assessed using the Infantile Colic Severity Questionnaire (ICSQ), a reliable and validated questionnaire for the diagnosis and evaluation of infant colic.
The numerical values assigned to the responses suppose a score for each item that varies between 1-4 points, where 1 indicates "less seriousness" and 4 "more serious". The total score of the questionnaire is obtained by adding the value achieved in each item, which can range from 24 to 100 points.
Measured: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Hours of sleep
The total number of hours of sleep will be measured using the Infantile Colic Severity Questionnaire (ICSQ)
Measured: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Stool
Possible changes regarding this variable will be evaluated using the Infantile Colic Severity Questionnaire (ICSQ), a reliable and validated questionnaire for the diagnosis and evaluation of infant colic.
The numerical values assigned to the responses suppose a score for each item that varies between 1-4 points, where 1 indicates "less seriousness" and 4 "more serious". The total score of the questionnaire is obtained by adding the value achieved in each item, which can range from 24 to 100 points.
Measured: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Use of drugs
It will be evaluated if the subjects take drugs at the beginning of the study, as well as the possible changes regarding this variable during the course of the study, using the Crying Diary completed by the parents.
Measured: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Apr 2021
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colic, InfantileStudies 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
- Model description
- A randomized controlled experimental clinical trial will be conducted where the evaluator and parents will be blinded to the allocation group for each subject
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Nuñez Fernandez, University of Seville
- Investigators
- David Nuñez Fernandez, PT, MsC, Principal investigator, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841590
- Sponsor's protocol ID
- 380263
- Status last verified
- Jun 2025
- First submitted
- 7 Apr 2021
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Osteopathic Manual Therapy on Infant Colic
- ClinicalTrials.gov ID
- NCT04841590
- Acronym / sponsor ID
- 380263
- Conditions
- Colic, Infantile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 12 Apr 2021 (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.
Infant colic (CL) is a common disorder that affects approximately 8-33% of newborns during the first months of life. Typically defined as "crying that lasts at least 3 hours a day, and occurs at least 3 days a week over a 3-week period." Osteopathic manual therapy is presented as an effective and safe alternative to CL treatment.
The main objective of the study is to quantify possible changes in daily crying hours and hours of sleep, the severity of CL, the frequency of episodes, changes in stool and possible adverse effects.
The study hypothesis argues that the application of osteopathic manual therapy in babies with CL produces an improvement in the hours of daily crying, the frequency of episodes, the severity of colic and the hours of sleep. A controlled RCT will be performed where the evaluator and the parents will be blinded with respect to the allocation group for each subject. Subjects who meet the inclusion and exclusion criteria will be randomly assigned to the experimental group (EG) and control group (CG) using a table of random numbers by a person from outside the research. The EG diagnosis treatment using techniques of osteopathic manual therapy, vertebral mobilization, cranial techniques and visceral mobilization, according to the diagnostic criteria of the therapist. The CG has no treatment.
A total of 3 procedures were performed, one per week, problems with the chronology in all groups (days 0, 7 and 14 if required).
The therapist in charge of performing the operations will be a Physiotherapist and Osteopath with more than 10 years of experience.
The evaluations will be carried out by a healthcare professional with more than 10 years of experience. The evaluator will be blinded. Parents blinded with respect to the allocation group of each subject until the end of the study.
To analyze the main variable of the study (total hours of excessive crying per day), use the crying diary completed by the parents. The Infantile Colic Severity Questionnaire (ICSQ) will be applied to evaluate the secondary variables (sleep, feces, frequency of episodes and severity of colic).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled experimental clinical trial will be conducted where the evaluator and parents will be blinded to the allocation group for each subject
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Intervention of the experimental group (EG)The experimental group (EG) will receive treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests. |
| Control Group | Sham comparator | Other: Control Group (CG)The control group (CG) will not receive any treatment |
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Inconsolable crying for more than 3 hours a day, at least 3 days a week for at least 3 weeks.
- Age 2 - 12 weeks.
- Gestation equal to or greater than 38 weeks.
- Birth weight equal to or greater than 2,500 grams.
- Weight gain of at least 150 grams. per week.
Key exclusion criteria (5 listed)
- Signs and / or symptoms of other pathologies.
- Signs of lactose intolerance.
- Having had benefits with the withdrawal of milk from maternal feeding or the use of milk with hydrolyzed casein.
- Having received the subjects and / or siblings, previous treatment with Osteopathy and / or Chiropractic.
- Contraindication to the treatment and / or some of its techniques; presence of congenital malformations.
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 |
|---|---|---|
| Intervention of the experimental group (EG)Treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests. | Other | Experimental Group |
| Control Group (CG)Subjects in the control group (CG) will not receive any treatment | Other | Control Group |
Primary outcome
Total hours of crying per day
Time frame: At the beginning of the study (pre-intervention)
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Total hours of crying per day
Time frame: 1 week after the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Total hours of crying per day
Time frame: 2 weeks after the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Total hours of crying per day
Time frame: 3 weeks after the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Total hours of crying per day
Time frame: Finally at 4 weeks from the first intervention
A crying diary completed by the parents will be used to compute the total hours per day that the subject presents crying.
Frequency of episodes
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Frequency of episodes
Time frame: 1 week after the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Frequency of episodes
Time frame: 2 weeks after the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Frequency of episodes
Time frame: 3 weeks after the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
Frequency of episodes
Time frame: Finally at 4 weeks from the first intervention
The total number of crying episodes per day will be assessed using the Crying Diary completed by the parents.
4 secondary outcomes
Colic Severity
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Hours of sleep
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Stool
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
Use of drugs
Time frame: At the beginning of the study (pre-intervention), 1 week after the first intervention, 2 weeks, 3 weeks and finally at 4 weeks from the beginning of the study
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 11 Jun 2025.
- Individual participant dataSharing planned: No
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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.
David Nuñez Fernandez, PT, MsC principal investigator
University of Seville
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention of the experimental group (EG) in people with Colic, Infantile, run by University of Seville at 3 sites in Spain.
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 7 inclusion and 5 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 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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?
Total hours of crying per day (time frame: At the beginning of the study (pre-intervention)). The study lists 10 primary outcomes in all. 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 11 Jun 2025.