Osteopathy is an international health service and osteopaths appear to utilise a range of therapeutic interventions, but there is a need for foundational research to establish a valid description of its intervention. Health services require an evidence base to establish a scientific foundation, to provide certainty to users and third party payers, to make comparisons with other services, to provide consumer choice and to influence practice. The process of establishing evidence has evolved alongside the development of scientific principles, and the current gold standard of evidence for healthcare is the randomised controlled trial. There are questions regarding whether this method is suitable for complex interventions like osteopathy and whether the findings reflect real-world practice.
This thesis aimed to establish an authentic model of osteopathic healthcare from the perspective of practitioners and patients, to review its evidence and to develop a clinical trial methodology that could test its effectiveness. Within a philosophical framework of pragmatism, an explanatory sequential mixed methods approach was used combining a practitioner survey and focus group, a patient snapshot of one day in practice, a patient survey and interviews, and a systematic literature review. Results from each of these studies were synthesised to develop a model of osteopathic healthcare, and a pragmatic clinical trial method was developed on the basis of the model using a Delphi panel.
The model of osteopathic healthcare demonstrated that it is consumer driven and health focused, has biopsychosocial foundations and manages patients who predominantly present with pain in multiple regions. The intervention is complex and follows a patient-centred model including a primary care assessment, individually tailored manual therapies, exercise and lifestyle advice, and includes cross disciplinary referrals with the health team. A pragmatic trial method was developed that reflected this model, and was designed to test the effectiveness of osteopathic healthcare on the most common presentation, chronic non-specific low back pain. This method had broad inclusion and specific exclusion criteria, an authentic intervention package and follow up, functional outcome measures and analysis by intention to treat.
The results have professional, educational and research implications for the future of the osteopathic profession. The process used in this thesis of developing a practice model and a clinical research method for a complex intervention can guide researchers in other fields. Completing a pragmatic clinical trial based on the method developed in this thesis will be a major step in the development of an evidence base for osteopathic healthcare.