NCT03771430

A Multidisciplinary Intervention in Total Knee Arthroplasty

A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 282 (estimated)
• Sponsor: Lovisenberg Diakonale Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the effectiveness of cognitive behavioral therapy delivered as an e-therapy program, combined with physical exercise delivered by physiotherapists, for patients on waiting list for total knee arthroplasty. The patients will be randomized to either 1) a non-surgical program consisting of web-based cognitive behavioral therapy combined with physiotherapy, 2) total knee arthroplasty (TKA) surgery followed by web-based cognitive behavioral therapy combined with physiotherapy, or 3) a control group who undergo TKA followed by standard physiotherapy.

Detailed description

The study is a multidisciplinary trial testing an intervention delivered by physiotherapists. Up to 20% of total knee arthroplasty (TKA) patients continue to experience moderate/severe pain 12 months after TKA. While physical therapy (PT) and cognitive-behavior therapy (CBT) have shown promise for improving outcomes, they have not been evaluated in combination or in patients at risk for chronic pain after TKA. This trial will evaluate PT+CBT combined, either as a substitute for or as a supplement to TKA for patients at risk for chronic pain after TKA. Pilot/Feasibility study: The study will include a feasibility/pilot study with 15 patients to be performed from November 2018. The intervention and study procedures may be modified based on results from the feasibility/pilot study. Full scale Randomized Controlled Trial (RCT): The full-scale RCT will include 282 patients scheduled for TKA. Patients will be randomly assigned to one of three groups: 1) non-surgical intervention (i.e., PT+CBT), 2) a combination of TKA with pre- and postoperative PT+CBT, or 3) A control group receiving TKA and usual care follow-up. Primary outcome: The Pain subscale from the KOOS. The intervention has the potential to improve outcomes for patients who currently obtain little benefit from standard TKA. Cross-sectional observational study: Patients declining to participate in the RCT will be offered the option to participate in a separate cross-sectional study. The inclusion and exclusion criteria will be identical to the RCT. Patients who agree to participate in the cross-sectional study will complete the same baseline questionnaires as in the RCT and are asked about the reasons they did not want to participate in the RCT.

Conditions

• Osteoarthritis; Primary
• Degenerative Joint Disease of Knee

Interventions

Type	Name	Description
BEHAVIORAL	Osteoarthritis education, exercise and CBT	Osteoarthritis Education 1. 60-min session by AktivA trained PT) * Signs/symptoms, risk factors, weight control, treatment * Importance of physical activity * Appropriate activity \& training modalities Exercise and CBT Support 2. 60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT) * Warm-up session * Strengthening exercises * Functional exercises * Stretching * Monitoring of CBT progress * Review of CBT lessons learned * Integration of CBT skills * Enhance motivation to continue Online CBT (iCBT) (10 modules completed at home) * Pain causes \& prevention * Pain management * Health promotion \& stress reduction at home \& work * Adapting for leisure \& work * Controlling flare-ups * Maintaining \& improving results
PROCEDURE	Total Knee Arthroplasty	Standard total knee arthroplasty will be performed.

Timeline

• Start date: 2019-08-28
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2018-12-11
• Last updated: 2023-01-18

Locations

3 sites across 1 country: Norway