Abstract
BackgroundOsteoarthritis is a leading cause of disability in developed nations. In Australia it afflicts 16.5% of the adult population. Total joint arthroplasty is considered the treatment of choice for end stage osteoarthritis. The number of total joint arthroplasties undertaken in Australia has doubled over the last decade (more than 80,000 procedures in 2011). The incidence of pre-operative psychological distress in this group of patients is reported between 30% and 60% and pre-operative psychological distress is associated with poorer pain and functional outcomes after surgery. This study will use a mindfulness-based psychological intervention to enhance outcomes in people undergoing total joint arthroplasty and, in addition, will test hypotheses about coping with chronic illness in an aged population. This study is the first of its kind and will provide a greater understanding of the role of a mental health enhancement program on the physical recovery of total joint arthroplasty patients.Methods/DesignOne hundred and fifty people with end-stage arthritis on the waiting list for total hip or knee arthroplasty will be recruited and randomly allocated to one of two groups using computer-generated block randomisation. A randomised controlled trial adhering to CONSORT guidelines will evaluate the efficacy of a mindfulness training program (weekly group-based classes in mindfulness practice, 2 ½ hours, for 8 weeks plus a 7-hour Saturday session in Week 6) prior to total joint arthroplasty, compared to a “standard care” group who will undergo routine total joint arthroplasty. Primary outcomes will be evaluated by a blinded examiner at baseline, 3 and 12 months post-surgery, using a validated self-reported pain and physical function scale. Secondary outcomes will include i) a range of validated measures of psychological wellbeing and ii) health economic analysis. All analyses will be conducted on an intention to treat basis using linear regression models. Health economic modelling will be applied to estimate the potential cost-effectiveness of mindfulness training and total joint arthroplasty.Trial registrationAustralian New Zealand Clinical Trials Registry (ANZCTRN12611001184965). Date of registration; 15th November 2011.
Highlights
Osteoarthritis is a leading cause of disability in developed nations
Psychological co-morbidities and traits reported in Total joint arthroplasty (TJA) patients include depression, anxiety, neuroticism, catastrophizing, poor self-esteem, and low self-efficacy, all of which are associated with poorer function and greater pain after TJA in short and longer term follow-up studies [2,3,4,5,6,7]
Keeping in mind the absence of previously established psychological interventions in arthroplasty, we propose that Mindfulness training (MT) prior to TJA is likely to be a suitable and effective intervention, leading to better outcomes
Summary
Osteoarthritis is a leading cause of disability in developed nations. In Australia, it afflicts 16.5% of the adult population and imposes a significant economic burden [1]. Our recent comprehensive literature review found preoperative psychological distress to be an independent predictor of pain and function after TJA in a majority of published studies [8]. This relationship has been noted for other major surgical procedures, e.g., herniated disc surgery [9] and coronary artery bypass graft surgery [10]. Preoperative psychological distress is associated with excessive analgesic intake, higher rates of hospital readmission, and long-erm mortality [14] Despite such findings, there is a dearth of literature examining psychological interventions or programs in surgical patients generally, and, to the best of our knowledge, there are no published intervention studies for TJA. Two exploratory aims of this study will be: i) to compare the cost effectiveness of this combination versus standard of care; ii) to investigate the influence of mindfulness training on candidate mediators of health outcomes drawn from psychological research on adaptation to illness–notably cognitive distortions, illness beliefs, and coping styles
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