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

Not Applicable
Conditions
Knee Osteoarthritis
Interventions
Behavioral: Patient education
Registration Number
NCT02587429
Lead Sponsor
Regional Hospital West Jutland
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).

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
84
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PatienteducationPatient education(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.
Primary Outcome Measures
NameTimeMethod
Pain measured on a Visual Analog Scale (0-100)12 months
Secondary Outcome Measures
NameTimeMethod
Tri-axial-accelerometer12 months

To measure physical activity for seven days

Six-minute Walk Test12 months
Sit-to-stand in 30 seconds12 months
Dual Energy X-ray Absorptiometry (DXA) scan12 months

To detect muscle mass

Short Form 36 (Physical Function)12 months
Pain Self-Efficacy Questionnaire (PSEQ)12 months
EuroQol (EQ-5D)12 months
Pain Catastrophizing Scale12 months
Knee injury and Osteoarthritis Outcome Score (KOOS)12 months
Oxford Knee Score12 months

Trial Locations

Locations (1)

Regional Hospital Holstebro

🇩🇰

Holstebro, Denmark

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