The effect of mindfulness training prior to total joint arthroplasty on post-operative pain and physical function: study protocol for a randomised controlled trial

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.

Latent Class Growth Analysis predicts long term pain and function trajectories in total knee arthroplasty: a study of 689 patients

“…A recent systematic review assessing the effect of numerous psychological factors on the outcomes of TKA reported strong evidence for both pre-operative pain catastrophizing and pre-operative mental well-being as predictors of persistent pain after TKA 30 . Cognitive behaviour therapy has been shown to be effective in the treatment of pain catastrophizing in fibromyalgia patients 31 , however evidence for the efficacy of mind-body therapies in improving physiological indices in patients undergoing surgery remains limited 32 and is the subject of future research by our group 33 .…”

Effectiveness and reporting standards of psychological interventions for improving short-term and long-term pain outcomes after total knee replacement: a systematic review

“…One RCT will evaluate a theory-based telephone-delivered patient self-management support intervention to enhance adherence to exercise after TKR 51. The final study is focused on a presurgery group-based mindfulness training programme to improve postoperative pain 52…”

Co-Morbidities and Sex Differences in Long-Term Quality-of-Life Outcomes among Patients with and without Diabetes after Total Knee Replacement: Five-Year Data from Registry Study

“…Given that a patient's baseline QoL is likely to be strongly correlated with their subsequent QoL over the follow-up period [43], there is scope to leverage the use of PROMs to optimize patients' well-being pre-operatively to improve post-surgical outcomes. A recent randomised controlled study investigating the efficacy of a mental health enhancement program prior to joint surgery found the program an effective strategy in improving pain and physical function among those at risk of poor response to surgery [44]. This therefore suggests that optimizing other aspects of patient's well-being beyond medication management and glycaemic control could also be an important consideration in ensuring better QoL outcomes post-surgery.…”