Osteopathy in infantile colic

• Research type

  Research Study

• Full title

  Cranial osteopathic manipulative therapy in addition to usual care in excessively crying infants, sometimes called colic: An external feasibility study for a pragmatic randomised controlled trial

• IRAS ID

  122457

• Contact name

  Anne Jakel

• Contact email

  annejakel@eso.ac.uk

• Clinicaltrials.gov Identifier

  NCT01942928

• Research summary

  Excessive Crying (Infantile Colic) is one of the most common complaints for which parents seek treatment. These otherwise healthy and well fed infants cry without identifiable cause, fuss a lot and are hard-to-soothe. This study aims to explore the feasibility of running a Randomised Controlled Trial (RCT) that investigates the effectiveness of cranial osteopathy in addition to usual NHS health visitor care in infants with colic.
  This feasibility study will comprise three elements, a small RCT, a short online survey and a qualitative interview-based study.
  Sixty excessively crying infants/infants with colic and their parents will be identified by health visitors and staff nurses as part of their routine post-natal care who will hand out information packs about the study. Parents who are interested in the study will contact the Research Team for further information. If happy to proceed, infants will be included into the study if they are healthy (full-term) and aged 1-7 weeks, identified as suffering from excessive crying/infantile colic, and have no serious illnesses. Participants will be randomised into the usual care group or the usual care plus cranial osteopathic intervention group. Osteopathic treatment, applied to the infant, will be individualized, according to clinical findings and will be carried out by experienced osteopaths in private practice. Usual care provided by health visitors and staff nurses will already be in place for all participants and will be maintained if needed throughout the study. Parents are asked to frequently fill questionnaires and a crying diary as well as some of them may be invited for face-to-face interview once the data collection period of nine weeks has ended. A short online survey will be administered to participating osteopaths and health visitors/staff nurses in order to explore their treatment/management practices.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  14/LO/0538

• Date of REC Opinion

  25 Apr 2014

• REC opinion

  Further Information Favourable Opinion