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

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

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.

Study Overview

• Status: Unknown
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Behavioral: Patient education

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 Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Regional Hospital Holstebro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patienteducation; (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.	Behavioral: Patient education
No Intervention: Control group 1; (Patients with PCS>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty.
No Intervention: Control group 2; (Patients with PCS<12). Patients in this arm will undergo usual treatment for total knee arthroplasty. Patients in this arm are not randomized but matched by age, gender and BMI with patients in control group 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain measured on a Visual Analog Scale (0-100)	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Regional Hospital West Jutland
• Investigators: Study Director: Torben B Hansen, professor,MD, University Clinic for Hand, Hip and Knee Surgery, HolstebroRegional Hospital, Aarhus University, Denmark

Publications and helpful links

General Publications

• Birch S, Stilling M, Mechlenburg I, Hansen TB. Effectiveness of a physiotherapist delivered cognitive-behavioral patient education for patients who undergoes operation for total knee arthroplasty: a protocol of a randomized controlled trial. BMC Musculoskelet Disord. 2017 Mar 21;18(1):116. doi: 10.1186/s12891-017-1476-6.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): January 1, 2021

Study Registration Dates

• First Submitted: October 23, 2015
• First Submitted That Met QC Criteria: October 23, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 27, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: VEK 1-10-72-64-15