Cranial Osteopathy in Infantile Colic

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by European School of Osteopathy
Sponsor:
Collaborators:
Sutherland Cranial College of Osteopathy
Sutherland Society
Information provided by (Responsible Party):
European School of Osteopathy
ClinicalTrials.gov Identifier:
NCT01942928
First received: September 11, 2013
Last updated: June 5, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Infantile Colic
Other: Usual NHS Care
Other: Osteopathic Manipulative Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic

Further study details as provided by European School of Osteopathy:

Primary Outcome Measures:
  • Change in daily hours crying time [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Parental Quality of life [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: June 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual NHS care 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.
Active Comparator: Usual NHS Care plus Osteopathic Manipulative Therapy 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.
Other: 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.

  Eligibility

Ages Eligible for Study:   up to 7 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942928

Contacts
Contact: Anne Jakel, BSc (Hons) Ost, DPhil 0044-1622 671558 annejakel@eso.co.uk

Locations
United Kingdom
European School of Osteopathy Recruiting
Maidstone, Kent, United Kingdom, ME14 3DZ
Contact: Jakel       annejakel@eso.ac.uk   
Principal Investigator: Anne Jakel, BSc (Hons) Ost, DPhil         
Sponsors and Collaborators
European School of Osteopathy
Sutherland Cranial College of Osteopathy
Sutherland Society
  More Information

No publications provided

Responsible Party: European School of Osteopathy
ClinicalTrials.gov Identifier: NCT01942928     History of Changes
Other Study ID Numbers: ESO-001-colic, ESO-001-2013
Study First Received: September 11, 2013
Last Updated: June 5, 2014
Health Authority: United Kingdom: National Health Service

Additional relevant MeSH terms:
Colic
Abdominal Pain
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on September 18, 2014