In the latter part of 2012, the Research Committee of the SCCO commenced preparation for a Blinded Randomised Controlled Trial of Colicky Infants treated with Paediatric or Cranial Osteopathy. Financial support for the study was provided by the Board of Trustees of the SCCO, by the The Sutherland Society and also a considerable amount of the costs were to be met by the ESO. Tenders were invited and the winning ‘bid’ was from the ESO research department led by Dr Anne Jakel. After much discussion it was agreed that the study would compare osteopathic care of colicky infants with standard NHS care. It was a golden opportunity to work with NHS Health Visitors in the Maidstone area of Kent, and discussions with them proved extremely worthwhile. The NHS care effectively provided the control ‘arm’ of the study. It was also agreed that this would be a feasibility study, which allows for changes in methodology to occur during the course of the study. This was also due to budgetary constraints as funds did not permit a large scale RCT. This was seen as a great opportunity to develop a research template that could be used by others to do comparative research trials. The more osteopathic research studies done on a a particular topic or condition, the better. One small study is simply not enough to draw meaningful conclusions from.
Once the protocol had been agreed, Medical Ethics Board approval was sought and eventually obtained, information packs were put together, osteopaths were recruited for the clinical work and the study commenced in June. However, recruitment of patients to the study proved very challenging. After Dr Jakel followed this up with more packs, more information, she finally learned that the Health Visitors were only seeing babies for 2 weeks after birth – a fundamental change in local Health Visitor practice to that when the initial discussions had taken place. They, thus, were not seeing the same numbers of colicky infants. This explained why the number of referrals for the study in the 3 months was non-existent.
Disappointing though this was, and after lengthy discussions with the ESO research team, the SCCO Research Committee agreed that a new opportunity could be embraced to compare methods of blinding a Colic Study. The Feasibility Study concept was an important part of this newly developed study, and it was decided that this would now be a ‘3-arm’ study in which sham treatment could be compared with osteopathic treatment and also no-treatment. Instead of referrals being dependent on Health Visitors, referrals would be from the ESO clinic or local osteopathic practices.
Whilst the original study offered a great opportunity to compare NHS and osteopathic practice and also develop a robust template, equally it was felt that this was a great opportunity to look at the much debated issues of blinding of a clinical research study, and this opportunity was one to be eagerly grasped. Results which were originally expected in 2015 will be delayed, but should make interesting reading.