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

Primary Purpose

Knee Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Patient education
Sponsored by
Regional Hospital West Jutland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Regional Hospital Holstebro

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Patienteducation

Control group 1

Control group 2

Arm Description

(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.

(Patients with PCS>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty.

(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.

Outcomes

Primary Outcome Measures

Pain measured on a Visual Analog Scale (0-100)

Secondary Outcome Measures

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

Full Information

First Posted
October 23, 2015
Last Updated
January 27, 2020
Sponsor
Regional Hospital West Jutland
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1. Study Identification

Unique Protocol Identification Number
NCT02587429
Brief Title
Effect of a Patient Education in Pain Coping for Patients Scheduled for Total Knee Arthroplasty
Official Title
Effect of a Patient Education in Pain Coping for Patients With High Levels of Pain Catastrophizing Before Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (undefined)
Primary Completion Date
May 2020 (Anticipated)
Study Completion Date
January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Regional Hospital West Jutland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patienteducation
Arm Type
Experimental
Arm Description
(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.
Arm Title
Control group 1
Arm Type
No Intervention
Arm Description
(Patients with PCS>22). Patients randomly assigned to this arm will undergo usual treatment for total knee arthroplasty.
Arm Title
Control group 2
Arm Type
No Intervention
Arm Description
(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.
Intervention Type
Behavioral
Intervention Name(s)
Patient education
Primary Outcome Measure Information:
Title
Pain measured on a Visual Analog Scale (0-100)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Six-minute Walk Test
Time Frame
12 months
Title
Sit-to-stand in 30 seconds
Time Frame
12 months
Title
EuroQol (EQ-5D)
Time Frame
12 months
Title
Pain Catastrophizing Scale
Time Frame
12 months
Title
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time Frame
12 months
Title
Short Form 36 (Physical Function)
Time Frame
12 months
Title
Dual Energy X-ray Absorptiometry (DXA) scan
Description
To detect muscle mass
Time Frame
12 months
Title
Tri-axial-accelerometer
Description
To measure physical activity for seven days
Time Frame
12 months
Title
Oxford Knee Score
Time Frame
12 months
Title
Pain Self-Efficacy Questionnaire (PSEQ)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torben B Hansen, professor,MD
Organizational Affiliation
University Clinic for Hand, Hip and Knee Surgery, HolstebroRegional Hospital, Aarhus University, Denmark
Official's Role
Study Director
Facility Information:
Facility Name
Regional Hospital Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
28320421
Citation
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.
Results Reference
derived

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

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