Effects of Osteopathic Manual Therapy on Infant Colic

NCT04841590 | Completed

• 1 other identifier: 380263
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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 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).

Conditions

Colic, Infantile

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  Finally at 4 weeks from the first intervention

Secondary Outcomes (4)

• Colic Severity

  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

  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

  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

  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

Study Arms (2)

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.

Other: Intervention of the experimental group (EG)

Control Group

SHAM COMPARATOR

The control group (CG) will not receive any treatment

Other: Control Group (CG)

Interventions

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.

Experimental Group

Control Group (CG) OTHER

Subjects in the control group (CG) will not receive any treatment

Control Group

Eligibility Criteria

• Age: 2 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (3)

Clinica de Fisioterapia y Osteopatía M4

Granada, Granada, 18003, Spain

Location

Hospital del Sureste

Madrid, Madrid, 28500, Spain

Location

Fisioterapia y Osteopatía David Nuñez

Madrid, Madrid, 28514, Spain

Location

MeSH Terms

Conditions

Colic

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• David Nuñez Fernandez, PT, MsC

  University of Seville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The evaluator will be blinded. Parents will be blinded to the allocation group to which each subject belongs until the end of the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized controlled experimental clinical trial will be conducted where the evaluator and parents will be blinded to the allocation group for each subject

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 12, 2021
• Study Start: April 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)