Background: One in five patients has no benefit from undergoing total knee arthroplasty (TKA). A number of preoperative factors may be used to identify patients with a higher risk for a poor outcome, including pain catastrophizing, poorer mental health and a higher number of painful sites. Physical exercise is the first-line treatment for osteoarthritis (OA) but a poorer mental health state may interfere with patients’ ability and motivation to exercise. Thus, an intervention for this subgroup of patients should include both physical and mental support, but there is a lack of evidence for the effectiveness of such an intervention. In addition, it is unknown whether these patients would benefit more from a non-surgical intervention, or from undergoing TKA supported by the intervention.
Aim: This randomized controlled trial will examine the effectiveness of a 12-week integrated PT exercise program and CBT, compared to usual treatment with TKA in patients with knee OA who are on a waiting list for TKA. The intervention will be evaluated both as a substitute for, and as a supplement to TKA, in comparison to TKA alone.
Methods/Design: The study will be conducted in 3 surgical clinics in Eastern and Western Norway. We will include 282 patients aged ≥18 and ≥80, and who are considered candidates for TKA by an orthopedic surgeon. The intervention will consist of a combination of physical exercised based on the Active with Osteoarthritis (AktivA) program, and an e-therapy CBT program developed for OA patients, supported by physiotherapists. Patients will be randomized to one of three groups: A non-surgical group, and a surgical group who will receive the intervention either instead of or in addition to TKA. The third group will be a control group who undergo surgery and usual care follow-up. The primary outcome will be change from baseline to 12 months on the pain subscale from the Knee Injury and Osteoarthritis Outcome Score (KOOS). The secondary outcomes include the remaining 4 subscores from the KOOS (Function, symptoms, activities of daily living, sports and recreation), EQ-5D-5L, the Pain Catastrophizing Scale, the 30 sec sit to stand test, 6 minutes walking test, ActivePal activity measures.
Discussion
This study is the first to investigate the effectiveness of an integrated intervention with physical exercise and CBT, on pain and functional outcomes in a subgroup of patients with higher risk for persistent pain following TKA. Findings from this trial will provide critical evidence about the effectiveness of this PT + CBT intervention for OA patients at high risk for poor surgical outcomes and chronic pain.
