A Multidisciplinary Intervention in Total Knee Arthroplasty - a Multicenter, Randomized Controlled Trial in OA Patients (The MultiKnee Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 6
- 主要终点
- Change in the knee injury and osteoarthritis score (KOOS) pain subscale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for TKA for OA at Lovisenberg, Oslo; Martina Hansen, Bærum, or Coastal Hospital Hagevik, Bergen
- •Age 18 - 79 years
- •ASA grade 1-3
- •KL grade 3 or 4
- •Able to read and write in Norwegian
排除标准
- •Diagnosis of dementia or sero-positive rheumatic disease
- •Previously undergone uni or patellofemoral prosthesis in the index knee
- •Large axis deviation or instability requiring use of hinged implants
- •Scheduled for unicompartmental arthroplasty or revision surgery
研究组 & 干预措施
Combined group
Total knee arthroplasty + osteoarthritis education, exercise and eCBT
干预措施: Osteoarthritis education, exercise and CBT (Behavioral)
Combined group
Total knee arthroplasty + osteoarthritis education, exercise and eCBT
干预措施: Total Knee Arthroplasty (Procedure)
Non-surgical group
Osteoarthritis education, exercise and eCBT
干预措施: Osteoarthritis education, exercise and CBT (Behavioral)
Surgery only (standard care)
Total knee arthroplasty + standard physiotherapy
干预措施: Total Knee Arthroplasty (Procedure)
结局指标
主要结局
Change in the knee injury and osteoarthritis score (KOOS) pain subscale
时间窗: Before randomization, 12 months after treatment start. Also measured at 3, 6, and 24 months after treatment start.12 months after treatment start will be the primary outcome.
KOOS is a knee-specific, patient administered questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire. The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. The pain subscale of the KOOS consists of 9 items that assess frequency of pain and pain severity in different situations. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. The pain subscale score will be transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
Change in the knee injury and osteoarthritis score (KOOS) pain subscale
时间窗: Measured before randomization, 3, 6, 12 and 24 months after treatment start.12 months after treatment start will be the primary endpoint.
KOOS is a knee-specific, patient administered questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. KOOS is validated for use in total knee arthroplasty and has been shown to be a valid, reliable and responsive measure. KOOS is a patient-administered questionnaire. The KOOS is a knee joint specific questionnaire with 42 items designed to assess patients' opinions about their difficulties with activity due to problems with their knees during the past week. The pain subscale of the KOOS consists of 9 items that assess frequency of pain and pain severity in different situations. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. The pain subscale score will be transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems.
次要结局
- The Forgotten Joint Score(Before randomization. 3, 6, 12 and 24 months following treatment start)
- Pain Catastrophizing Scale(Before randomization. 3, 6, 12 and 24 months following treatment start)
- Patient-acceptable symptom state, perceived treatment failure.(At 3, 6, 12 and 24 months following treatment start.)
- Global perceived effect(At 3, 6, 12 and 24 months following treatment start.)
- Adverse events/serious adverse events(From treatment start until 24 months following treatment start.)
- Knee injury and osteoarthritis score (KOOS) subscores: Other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL)(Before randomization. 3, 6, 12 and 24 months following treatment start)
- The 30 second sit to stand test(Before treatment start. 3, 6, 12 and 24 months following treatment start)
- Brief Pain inventory(Before randomization. 3, 6, 12 and 24 months following treatment start)
- EuroQol-5D-5L(Before randomization. 3, 6, 12 and 24 months following treatment start)
- Knee injury and osteoarthritis score (KOOS) subscores: Other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related quality of life (QOL)(Before randomization. 3, 6, 12 and 24 months following treatment start.12 months after treatment start will be the secondary endpoint.)
- General health state(Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.)
- Pain Catastrophizing Scale(Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.)
- Patient-acceptable symptom state, perceived treatment failure.(At 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.)
- The 30 second sit to stand test(Before treatment start. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint.)
- Adverse events/serious adverse events(From treatment start until 12 months following treatment start.)