Cranial Osteopathy in Infantile Colic
Recruitment status was: Recruiting
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.
|Infantile Colic||Other: Usual NHS Care Other: Osteopathic Manipulative Therapy|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
|Official Title:||Cranial Osteopathic Manipulative Therapy in Addition to Usual Care in Excessively Crying Infants, Sometimes Called Colic|
- Change in daily hours crying time [ Time Frame: 4 weeks ]
- Parental Quality of life [ Time Frame: 4 weeks ]
|Study Start Date:||June 2014|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01942928
|Contact: Anne Jakel, BSc (Hons) Ost, DPhil||0044-1622 firstname.lastname@example.org|
|European School of Osteopathy||Recruiting|
|Maidstone, Kent, United Kingdom, ME14 3DZ|
|Contact: Jakel email@example.com|
|Principal Investigator: Anne Jakel, BSc (Hons) Ost, DPhil|