Degenerative Joint Disease of Knee, Osteoarthritis; Primary
Conditions
Keywords
Total knee arthroplasty, Physiotherapy, Cognitive behavioral therapy, e-therapy
Brief 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.
Interventions
BEHAVIORALOsteoarthritis 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
PROCEDURETotal Knee Arthroplasty
Standard total knee arthroplasty will be performed.
Sponsors
Lovisenberg Diakonale Hospital
Haukeland University Hospital
Vestre Viken Hospital Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
1. Scheduled for TKA for OA at Lovisenberg, Oslo; Martina Hansen, Bærum, or Coastal Hospital Hagevik, Bergen 2. Age 18 - 79 years 3. ASA grade 1-3 4. KL grade 3 or 4 5. BMI\<40 6. Able to read and write in Norwegian
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the knee injury and osteoarthritis score (KOOS) pain subscale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | KOOS is a knee-specific questionnaire developed to evaluate short- and long-term symptoms and functioning in subjects with knee injury and osteoarthritis. 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. KOOS has 5 subscales: pain, other symptoms, activities of daily living (ADL), function in sport and recreation, and knee-related QOL. The KOOS has been validated for use in TKA and has been shown to be valid, reliable and responsive. Each of the 42 items carries equal weighting (0-4), with higher scores indicating better functioning. Each of the subscale scores are transformed to a 0-100 scale, with 0 representing extreme knee problems and 100 representing no problems. KOOS is a patient-administered questionnaire. |
| General health state | Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint. | Patients' perceived health state will be measured on a visual analog scale that range from 0 - 100, higher levels indicate better health state, using the widely used EuroQol-5 (EQ-5D-5L). Only the health-state item will be a secondary outcome. The remaining parts of the EQ-5D-5L will be included in the economic evaluation of the intervention. |
| Pain Catastrophizing Scale | Before randomization. 3, 6, 12 and 24 months following treatment start. 12 months after treatment start will be the secondary endpoint. | The Pain Catastrophizing scale (PCS) will be used to measure catastrophic thinking related to pain. The scale consist of 13 items that range from 0 -4. The PCS assesses three dimensions of catastrophizing (i.e., rumination (range 0-16), magnification (range: 0-12, helplessness (range 0 -24). Higher scores indicate higher levels of catastrophic thinking related to pain. A total score can be computed by summing responses to all 13 items. PCS total scores range from 0-52. Higher scores indicate higher levels of catastrophic thinking related to pain. |
| 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. | Patient-acceptable symptom state will be measured by a single item question. The patient state wether they consider their knee function satisfactory or not (Yes/No). Perceived treatment failure will be measured by a single item question. The patient state whether their situation is so dissatisfying that they consider the treatment as a failure (Yes/No). |
| 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. | The 30-second sit to stand test will be used to assess functional lower extremity strength. This test is performed using a chair of standard height without arms. The participant is encouraged to complete as many full stands as possible within 30 seconds. |
| Adverse events/serious adverse events | From treatment start until 12 months following treatment start. | All events reported by participant, physiotherapist or documented in the patient's hospital record. * During surgery: Number of patients with fractures (Tibia, patella, femur), nerve or vascular injury, rupture of patella tendon, other. * Postoperatively: Number of patients with deep infection, any secondary surgery (e.g., skin necrosis or scar tissue adherences, DAIR, MUA, secondary insertion of patella component, partial/total revision surgery), supracondylar femur fracture, patella fracture, permanent n. peroneus paresis, aseptic loosening, polyethylene defect (tibia or patella), instability requiring intervention, thrombophlebitis demanding anticoagulant treatment, pulmonary embolism, myocardial infarction, cerebral insult, other events. * Patient-reported myocardial infarction, cerebral insult, pulmonary embolism or DVT within 3 months following intervention. * All events reported by patients or physiotherapists - open probe questionnairing |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORMaren F Lindberg, PhD
Lovisenberg Diakonale Hospital/University of Oslo
STUDY_CHAIRAnners Lerdal, PhD
Lovisenberg Diaconal Hospital, University of Oslo
Outcome results
None listed