Infant ColicNCT02727530
The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)
A study testing VISCERAL MANUAL THERAPY-ADVICES and ADVICES in people with Infant Colic, run by University of Seville at 1 site in Spain.
Trial summary
The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents. Read more about this study
- Who is it for?
- Ages 1 day to 180 days
- Conditions the study is for
- Infant Colic
- What is being tested?
- VISCERAL MANUAL THERAPY-ADVICES and ADVICES
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2016to Jul 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 1 day to 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with medical diagnostic of colic following Wessel criteria.
Who cannot join
- Infant's parents without full capacity to answer the survey questions, such as the existence of intellectual disability.
- Babies with neurological disorders such epilepsy, meningitis, encephalitis, cerebral palsy, spina bifida, hydrocephalus, encephalopathy, Arnold Chiari malformation, syringomyelia and Huntington's disease.
- Babies with digestive disorders, such Crohn's disease, irritable bowel syndrome, peritonitis, intestinal malabsorption, hepatitis, diverticular bowel disease, esophagitis, Intussusception and Ulcerative Colitis.
- Babies with congenital diseases such Angelmen syndrome, Down syndrome, cystic fibrosis, haemophilia, Klinefelter syndrome, Neurofibromatosis, Patau syndrome and Tay Sachs syndrome.
- Babies with traumatology - orthopedic pathologies such idiopathic scoliosis, spondylolisthesis, Perthes disease, Meyer dysplasia, Marfan syndrome, Morquio syndrome and congenital hip dislocation.
- Babies with dermatological diseases such Atopic dermatitis, staphylococcal scalded skin syndrome, psoriasis, urticaria and disorders of skin pigmentation.
- Babies who are subjected to drug treatments that are not specific to the treatment of colic.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Seville, Sevilla, 41009
About this study
Official title: The Effects of Visceral Manual Therapy on Infant Colic Symptoms. A Controlled Clinical Trial
The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.
Read the detailed description
Background:
Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.
Objectives:
To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.
- Conditions
- Infant Colic
- Being tested
- VISCERAL MANUAL THERAPY-ADVICES, ADVICES
- Keywords
- Infant Colic, Manual Therapy, Effectiveness
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISCERAL MANUAL THERAPY-ADVICESOther
The subjects of this group will receive an amount of two sessions of visceral manual therapy that will be applied within two weeks. In the first session will be applied procedures in the most superficial body structures. And, in the second session will be applied procedures in the most deep body structures.
ADVICESOther
Advices for parents to improve the management of infant colic
| Study group | Role | What they receive |
|---|---|---|
| GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES | Experimental | Subjects will receive 2 manual therapy sessions and advices. Receives: Other: VISCERAL MANUAL THERAPY-ADVICES; Other: ADVICES |
| GROUP RECEIVING ADVICES | Experimental | Subjects will receive advices. Receives: Other: ADVICES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from parents-reported infant colic severity at 3 weeks
Evaluated by the infant colic severity scale
Measured: At the start of the study and one week after the second session (three weeks after the start of the study)
Secondary outcomes (1)
Change from parents-reported infant cry at 3 weeks
Evaluated by cry-related items of the infant colic severity scale
Measured: At the start of the study and one week after the second session (three weeks after the start 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 posted4 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Infant 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raquel Chillón Martínez, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727530
- Sponsor's protocol ID
- USeville-RMartinez
- Status last verified
- Apr 2016
- First submitted
- 29 Mar 2016
- Last updated
- 12 Jul 2016
- Results posted
- No
Publications
WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.
PubMed 13214956Wurmser H, Laubereau B, Hermann M, Papousek M, von Kries R. Excessive infant crying: often not confined to the first 3 months of age. Early Hum Dev. 2001 Aug;64(1):1-6. doi: 10.1016/s0378-3782(01)00166-9.
PubMed 11408103Ernst E. Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials. Int J Clin Pract. 2009 Sep;63(9):1351-3. doi: 10.1111/j.1742-1241.2009.02133.x.
PubMed 19691620Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child. 2001 Feb;84(2):138-41. doi: 10.1136/adc.84.2.138.
PubMed 11159288Reinthal M, Lund I, Ullman D, Lundeberg T. Gastrointestinal symptoms of infantile colic and their change after light needling of acupuncture: a case series study of 913 infants. Chin Med. 2011 Aug 11;6:28. doi: 10.1186/1749-8546-6-28.
PubMed 21835014Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov 15.
PubMed 24228748Larsen JH. Infants' colic and belly massage. Practitioner. 1990 Apr 22;234(1487):396-7. No abstract available.
PubMed 2367295
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Visceral Manual Therapy on Infant Colic Symptoms. A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02727530
- Acronym / sponsor ID
- USeville-RMartinez
- Conditions
- Infant Colic
- Keywords
- Infant Colic, Manual Therapy, Effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 4 Apr 2016 (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.
The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.
Detailed description
Background:
Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.
Objectives:
To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES | Experimental | Other: VISCERAL MANUAL THERAPY-ADVICES, Other: ADVICESSubjects will receive 2 manual therapy sessions and advices. |
| GROUP RECEIVING ADVICES | Experimental | Other: ADVICESSubjects will receive advices. |
Who may qualify
- Ages
- 1 day to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Infants with medical diagnostic of colic following Wessel criteria.
Key exclusion criteria (7 listed)
- Infant's parents without full capacity to answer the survey questions, such as the existence of intellectual disability.
- Babies with neurological disorders such epilepsy, meningitis, encephalitis, cerebral palsy, spina bifida, hydrocephalus, encephalopathy, Arnold Chiari malformation, syringomyelia and Huntington's disease.
- Babies with digestive disorders, such Crohn's disease, irritable bowel syndrome, peritonitis, intestinal malabsorption, hepatitis, diverticular bowel disease, esophagitis, Intussusception and Ulcerative Colitis.
- Babies with congenital diseases such Angelmen syndrome, Down syndrome, cystic fibrosis, haemophilia, Klinefelter syndrome, Neurofibromatosis, Patau syndrome and Tay Sachs syndrome.
- Babies with traumatology - orthopedic pathologies such idiopathic scoliosis, spondylolisthesis, Perthes disease, Meyer dysplasia, Marfan syndrome, Morquio syndrome and congenital hip dislocation.
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 |
|---|---|---|
| VISCERAL MANUAL THERAPY-ADVICESThe subjects of this group will receive an amount of two sessions of visceral manual therapy that will be applied within two weeks. In the first session will be applied procedures in the most superficial body structures. And, in the second session will be applied procedures in the most deep body structures. | Other | GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES |
| ADVICESAdvices for parents to improve the management of infant colic | Other | GROUP RECEIVING ADVICES, GROUP RECEIVING VISCERAL MANUAL THERAPY-ADVICES |
Primary outcome
Change from parents-reported infant colic severity at 3 weeks
Time frame: At the start of the study and one week after the second session (three weeks after the start of the study)
Evaluated by the infant colic severity scale
1 secondary outcome
Change from parents-reported infant cry at 3 weeks
Time frame: At the start of the study and one week after the second session (three weeks after the start 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 12 Jul 2016.
- Results publication: PubMed 13214956WESSEL MA, COBB JC, JACKSON EB, HARRIS GS Jr, DETWILER AC. Paroxysmal fussing in infancy, sometimes called colic. Pediatrics. 1954 Nov;14(5):421-35. No abstract available.
- Results publication: PubMed 11408103Wurmser H, Laubereau B, Hermann M, Papousek M, von Kries R. Excessive infant crying: often not confined to the first 3 months of age. Early Hum Dev. 2001 Aug;64(1):1-6. doi: 10.1016/s0378-3782(01)00166-9.
- Results publication: PubMed 19691620Ernst E. Chiropractic spinal manipulation for infant colic: a systematic review of randomised clinical trials. Int J Clin Pract. 2009 Sep;63(9):1351-3. doi: 10.1111/j.1742-1241.2009.02133.x.
- Results publication: PubMed 11159288Olafsdottir E, Forshei S, Fluge G, Markestad T. Randomised controlled trial of infantile colic treated with chiropractic spinal manipulation. Arch Dis Child. 2001 Feb;84(2):138-41. doi: 10.1136/adc.84.2.138.
- Results publication: PubMed 21835014Reinthal M, Lund I, Ullman D, Lundeberg T. Gastrointestinal symptoms of infantile colic and their change after light needling of acupuncture: a case series study of 913 infants. Chin Med. 2011 Aug 11;6:28. doi: 10.1186/1749-8546-6-28.
- Results publication: PubMed 24228748Skjeie H, Skonnord T, Fetveit A, Brekke M. Acupuncture for infantile colic: a blinding-validated, randomized controlled multicentre trial in general practice. Scand J Prim Health Care. 2013 Dec;31(4):190-6. doi: 10.3109/02813432.2013.862915. Epub 2013 Nov 15.
- Results publication: PubMed 2367295Larsen JH. Infants' colic and belly massage. Practitioner. 1990 Apr 22;234(1487):396-7. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VISCERAL MANUAL THERAPY-ADVICES and ADVICES in people with Infant Colic, run by University of Seville at 1 site 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 1 inclusion and 7 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 12 Jul 2016. 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 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. 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 from parents-reported infant colic severity at 3 weeks (time frame: At the start of the study and one week after the second session (three weeks after the start of the study)). 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 NCT02727530, which also lists 7 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 12 Jul 2016.