Cranial Osteopathy in Infantile Colic
Primary Purpose
Infantile Colic
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Usual NHS Care
Osteopathic Manipulative Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Infantile Colic
Eligibility Criteria
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
Sites / Locations
- European School of OsteopathyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Usual NHS care
Usual NHS Care plus Osteopathic Manipulative Therapy
Arm Description
Outcomes
Primary Outcome Measures
Change in daily hours crying time
Secondary Outcome Measures
Parental Quality of life
Full Information
NCT ID
NCT01942928
First Posted
September 11, 2013
Last Updated
February 19, 2015
Sponsor
European School of Osteopathy
Collaborators
Sutherland Cranial College of Osteopathy, Sutherland Society
1. Study Identification
Unique Protocol Identification Number
NCT01942928
Brief Title
Cranial Osteopathy in Infantile Colic
Official Title
Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Unknown status
Study Start Date
June 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European School of Osteopathy
Collaborators
Sutherland Cranial College of Osteopathy, Sutherland Society
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infantile Colic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual NHS care
Arm Type
Active Comparator
Arm Title
Usual NHS Care plus Osteopathic Manipulative Therapy
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Usual NHS Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Osteopathic Manipulative Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in daily hours crying time
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Parental Quality of life
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
7 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Jakel, BSc (Hons) Ost, DPhil
Phone
0044-1622 671558
Email
annejakel@eso.co.uk
Facility Information:
Facility Name
European School of Osteopathy
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME14 3DZ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jakel
Email
annejakel@eso.ac.uk
First Name & Middle Initial & Last Name & Degree
Anne Jakel, BSc (Hons) Ost, DPhil
12. IPD Sharing Statement
Learn more about this trial
Cranial Osteopathy in Infantile Colic
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