Cranial Osteopathy in Infantile Colic

Infantile Colic Clinical Trial

Official title:

Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01942928
• Other study ID #: ESO-001-colic
• Secondary ID: ESO-001-2013
• Status: Recruiting
• Phase: N/A
• First received: September 11, 2013
• Last updated: February 19, 2015
• Start date: June 2014

Study information

• Verified date: February 2015
• Source: European School of Osteopathy
• Contact: Anne Jakel, BSc (Hons) Ost, DPhil
• Phone: 0044-1622 671558
• Email: annejakel[@]eso.co.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

Background Excessive Crying (Infantile Colic) is one of the most common complaints for which parents seek treatment. These otherwise healthy and well fed infants show no signs of failure to thrive, cry without identifiable cause, fuss a lot and are hard-to-soothe.

Objective To explore the feasibility of running a Randomised Controlled Trial (RCT) that investigates the effectiveness of cranial osteopathy in addition to usual National Health Service (NHS) care in infants with colic.

Methods Pragmatic randomised controlled trial, involving United Kingdom (UK) osteopaths in private practice and NHS health visitors. Parents of 60 excessively crying infants/infants with colic will be recruited by NHS health visitors. Infants will be included into the study if they are healthy (full-term) and aged 1-7 weeks, diagnosed with excessive crying/infantile colic, and have no co-morbidities. Participants will be randomised into the usual NHS care group or the usual NHS care plus cranial osteopathic intervention group.

Usual NHS care will be provided by health visitors and osteopathic treatment will be carried out by experienced osteopaths in private practice.

Primary outcome measures are acceptability and feasibility of intervention procedures. Furthermore, changes in the frequency and duration of crying will be documented in a daily crying diary. Parental quality of life will also be assessed.

This pilot investigation will provide useful information in order to further develop and adapt the current interventions and trial procedures with a view to a full-scale randomised controlled trial.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 7 Weeks

Eligibility

Inclusion Criteria:

• healthy, diagnosed with excessive crying by NHS Health Visitors No comorbidities Parents are able to adequately communicate in English

Exclusion Criteria:

• Currently participating in other therapeutic clinical trials Currently receive manual therapy treatment

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colic
• Infantile Colic

Intervention

Other:
• Usual NHS Care
Usual NHS care is provided by a health visitor who will diagnose excessively crying infants/infants with colic in the first instance. Parents usually will then have the opportunity to consult their health visitor when needed. The health visitor will provide support and advice on how to manage the condition within their professional remit.
• Osteopathic Manipulative Therapy
Osteopathic treatment will be provided by experienced osteopaths once a week for up to four weeks, depending on needs. Treatment will be individualised, according to clinical findings, and involves using standard cranial osteopathic techniques. All parents will be able to ask questions.

Locations

Country	Name	City	State
United Kingdom	European School of Osteopathy	Maidstone	Kent

Sponsors (3)

Lead Sponsor	Collaborator
European School of Osteopathy	Sutherland Cranial College of Osteopathy, Sutherland Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in daily hours crying time		4 weeks	No
Secondary	Parental Quality of life		4 weeks	No