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

Knee Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02587429
• Other study ID #: VEK 1-10-72-64-15
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2015
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: Regional Hospital West Jutland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: January 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Patient education

Locations

Country	Name	City	State
Denmark	Regional Hospital Holstebro	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Regional Hospital West Jutland

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measured on a Visual Analog Scale (0-100)		12 months
Secondary	Six-minute Walk Test		12 months
Secondary	Sit-to-stand in 30 seconds		12 months
Secondary	EuroQol (EQ-5D)		12 months
Secondary	Pain Catastrophizing Scale		12 months
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)		12 months
Secondary	Short Form 36 (Physical Function)		12 months
Secondary	Dual Energy X-ray Absorptiometry (DXA) scan	To detect muscle mass	12 months
Secondary	Tri-axial-accelerometer	To measure physical activity for seven days	12 months
Secondary	Oxford Knee Score		12 months
Secondary	Pain Self-Efficacy Questionnaire (PSEQ)		12 months