Viewing Study NCT02587429



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Last Modification Date: 2024-10-26 @ 11:51 AM
Study NCT ID: NCT02587429
Status: UNKNOWN
Last Update Posted: 2020-01-28
First Post: 2015-10-23

Brief Title: Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty
Sponsor: Regional Hospital West Jutland
Organization: Regional Hospital West Jutland

Study Overview

Official Title: Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty
Status: UNKNOWN
Status Verified Date: 2020-01
Last Known Status: ACTIVE_NOT_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None