Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty

Study Overview
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Brief Summary
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The aim of this study is to investigate, whether a patient education with focus on pain coping is able to improve physical function and experienced pain level in patients with high levels of pain catastrophizing before Total Knee Arthroplasty. Resent studies indicates that these patients do not achieve a satisfactory pain relief and physical function after TKA. Furthermore, the aim is to determine if there is a difference in physical activity and muscle mass among patients with high levels of pain catastrophizing compared to patients with low levels of pain catastrophizing.

Detailed Description
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In Denmark, are approximately 8000 patients operated annually with Knee Arthroplasty. Most of these patients will have less pain and higher functional ability after the surgery. However, some patients respond poorly to the surgery and approximately 20% of the patients report persistent function-limiting pain six months or more following a total knee arthroplasty (TKA). Research has shown that patients with high pain catastrophizing scores are at higher risk of having persistent pain and lower physical function after the operation. This study consists of two parts. The first part is a randomised controlled trial where 56 patients with high levels of pain catastrophizing before TKA are randomised to either treatment as usual (control group 1), which implies surgery and the standard postoperative rehabilitation, or in addition to this, a patient education focusing on pain behaviour and pain coping (patient education). In the second part the patients in control group 1 will be matched on age, BMI and gender with additionally 28 patients with a low levels of pain catastrophizing (control group 2).

Official Title
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Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age above 18 years Inability to understand and communicate with the investigators Scheduled for an elective unilateral total knee arthroplasty Primary diagnosis of osteoarthritis Score greater than 22 or lower than 12 on the Pain Catastrophizing Scale (PCS) Exclusion Criteria: Planned to undergo another elective joint replacement procedure during the 12 months period of participation Scheduled for revision arthroplasty surgery TKA surgery scheduled because of fracture, malignancy or infection Scheduled for Unicompartmental knee arthroplasty Major depression diagnosed with the Major Depression Index (MDI)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patienteducation<br>(Patients with PCS>22). An education in pain coping delivered by physiotherapists. The education consist of seven sessions over a four months period. Each session is individual and will last 30 minutes. Focus will be on pain behaviour and pain coping based on Cognitive Behavioral Therapy. | Behavioral: Patient education<br> <br> |
| No Intervention: Control group 1<br>(Patients with PCS>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty. | |
| No Intervention: Control group 2<br>(Patients with PCS<12). Patients in this arm will undergo usual treatment for total knee arthroplasty. Patients in this arm are not randomized but matched by age, gender and BMI with patients in control group 1. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measured on a Visual Analog Scale (0-100) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six-minute Walk Test |  | 12 months | 
| Sit-to-stand in 30 seconds |  | 12 months | 
| EuroQol (EQ-5D) |  | 12 months | 
| Pain Catastrophizing Scale |  | 12 months | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) |  | 12 months | 
| Short Form 36 (Physical Function) |  | 12 months | 
| Dual Energy X-ray Absorptiometry (DXA) scan | To detect muscle mass | 12 months | 
| Tri-axial-accelerometer | To measure physical activity for seven days | 12 months | 
| Oxford Knee Score |  | 12 months | 
| Pain Self-Efficacy Questionnaire (PSEQ) |  | 12 months |