Developing and Evaluating a Complex Intervention to Treat Chronic Orofacial Pain

Goldthorpe, Joanna and Lovell, Karina and Peters, Sarah and Aggarwal, Vishal (2012) Developing and Evaluating a Complex Intervention to Treat Chronic Orofacial Pain. PhD thesis, University of Manchester.

Abstract

Abstract Introduction: Chronic orofacial pain (COFP) is distressing and disabling to sufferers and can be costly to patients, health services and society. Frequently, no underlying medical pathology can be found to account for the condition. Despite this, patients are treated according to a biomedical model, often by mechanistic and invasive procedures, which tend to be unsuccessful and not evidence based. Evidence suggests that cognitive behavioural therapy (CBT) based management may produce improved outcomes for patients. However, published studies can tell us little about which intervention components are effective, or recommend an optimum way for these components to be applied. Aim: To develop an evidence based intervention for the management of COFP that is feasible and acceptable to patients and practitioners. Method: The Medical Research Council’s guidelines for developing complex interventions were used as a framework for the research. Evidence from multiple sources was synthesised to produce the draft components of an intervention to manage COFP. An exploratory trial investigated preliminary outcomes, acceptability, feasibility and explored parameters for a full scale randomised control trial. Results: The intervention was acceptable to participants and could be feasibly implemented. No conclusions could be drawn relating to the effectiveness of the intervention. Participants were not affected at baseline for a number of outcomes, which implies that cut off points should be introduced into the inclusion and exclusion criteria of any future studies. Conclusion: The study produced an intervention which is acceptable and feasible to participants, however it is not known if it is effective. A number of recommendations are made for progression to a larger, definitive trial.