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Clinical Trials/NCT02587429
NCT02587429
Unknown
N/A

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

Regional Hospital West Jutland1 site in 1 country84 target enrollmentOctober 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Regional Hospital West Jutland
Enrollment
84
Locations
1
Primary Endpoint
Pain measured on a Visual Analog Scale (0-100)
Last Updated
6 years ago

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).

Registry
clinicaltrials.gov
Start Date
October 2015
End Date
January 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Regional Hospital West Jutland
Responsible Party
Principal Investigator
Principal Investigator

Sara Birch

Physiotherapist, PhD Student

Regional Hospital West Jutland

Eligibility Criteria

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)

Study Sites (1)

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