Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 84
- Locations
- 2
- Primary Endpoint
- Pain measured on a Visual Analog Scale (0-100)
Study Overview
Brief Summary
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
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
Pain measured on a Visual Analog Scale (0-100)
Time Frame: 12 months
Secondary Outcomes
- Tri-axial-accelerometer(12 months)
- Six-minute Walk Test(12 months)
- Sit-to-stand in 30 seconds(12 months)
- Dual Energy X-ray Absorptiometry (DXA) scan(12 months)
- Short Form 36 (Physical Function)(12 months)
- Pain Self-Efficacy Questionnaire (PSEQ)(12 months)
- EuroQol (EQ-5D)(12 months)
- Pain Catastrophizing Scale(12 months)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(12 months)
- Oxford Knee Score(12 months)
Investigators
Sara Birch
Physiotherapist, PhD Student
Regional Hospital West Jutland