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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering

Cost-effectiveness of a multidisciplinary intervention and subsequent use of health care resources in patients on waiting list for TKA

Alternative title: Kost-nytteanalyse av en multidisiplinær intervensjon og påfølgende bruk av helsetjenester hos pasienter på venteliste for total kneprotese

Awarded: NOK 10.0 mill.

This study will test the effectiveness of physical exercise in combination with mental training for patients with painful knee osteoarthritis, on waiting list for surgery with total knee replacement. Physiotherapists will have a central role in this study, who will take place at Lovisenberg Deaconal Hospital, Oslo, Martina Hansens Hospital, Bærum and Coastal Hospital Hagevik, Bergen. The intervention will consist of two parts. One part will be the lifestyle- and exercise program Active with Osteoarthritis (AktivA), and the second part will consist of a web-based program for mental training. Physiotherapists will be responsible for the AktivA part of the intervention and will follow the patients through the study period. In addition, patients will perform the web-based course in mental training supported by physiotherapists, specially developed for patients with osteoarthritis. Patients will join two weekly AktivA group sessions over 12 weeks, where they will perform individually adjusted exercise under supervision of a physiotherapist. The patients will complete one module a week of the web-based program for mental training. They will complete a total of 10 modules. Patients will be randomly allocated to one of three groups. Group 1 will be a non-surgical group. Patients will receive 2 weekly sessions of AktivA combined with web-based mental training for 12 weeks. Group 2 will receive AktivA and mental training in combination with surgery for total knee arthroplasty. First, patients undergo surgery with a total knee replacement. After surgery, they receive the intervention for 12 weeks. Patients can attend regular physiotherapy after the 12 weeks intervention period. Group 3 will be a control group who undergo total knee replacement followed by usual care physiotherapy (usually physiotherapy for 4-6 months).

Total knee arthroplasty (TKA) is a common procedure to provide pain relief and improve function in patients with end-stage osteoarthritis (OA). Up to 20% of TKA patients continue to experience moderate to severe pain 12 months after surgery. A validated algorithm has been used in prior studies to identify these patients based on preoperative criteria, but no interventions have been tested and proven to be effective and cost-effective in these patients. Physical therapy (PT) and cognitive-behavior therapy (CBT) have shown promise in several prior studies, but have not been evaluated in combination or specifically for patients at risk for chronic pain after surgery. Thus, this multicenter randomized controlled trial will evaluate a multidisciplinary intervention (PT+CBT), either as a substitute for or as a supplement to TKA for patients at risk for chronic pain after surgery. The trial will include 230 patients scheduled for TKA surgery and identified as being at risk for chronic pain based on previously established preoperative criteria. The patients will be randomly assigned to one of three groups: 1) standard care (i.e., TKA), 2) non-surgical intervention (i.e., PT+CBT), or 3) a combination of TKA with postoperative PT+CBT. This study will evaluate the cost-effectiveness of the interventions, and the effect of physical performance and on psychological outcomes 2 years following the intervention. It will also utilize registry-based data to evaluate patients’ use of health care resources in the 2 years following the interventions. The results from this trial will provide critical evidence for whether this multidisciplinary intervention, either as a means of delaying or avoiding surgical intervention or as a supplement to it, can improve outcomes at lower costs, for patients who are currently obtaining little benefit from standard TKA.

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BEHANDLING-God og treffsikker diagnostikk, behandling og rehabilitering