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Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial (KASTPain)

Primary Purpose

Knee Osteoarthritis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pain Coping Skills Training
Arthritis Education
Usual Care
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring arthroplasty, pain

Eligibility Criteria

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

Inclusion Criteria:

  • Adults 45 years and older and capable of providing informed consent
  • Diagnosis of osteoarthritis as determined by participating orthopaedic surgeons
  • Scheduled for an elective unilateral total or unicompartmental knee arthroplasty no sooner than 1 week and no later than 8 weeks from the time of recruitment
  • Score of greater than or = to 16 on the Pain Catastrophizing Scale
  • Score of greater than or = to 5 on the WOMAC Pain Scale
  • Able to read and speak English

Exclusion Criteria:

  • Scheduled for revision arthroplasty surgery
  • Underwent contralateral knee arthroplasty surgery or hip arthroplasty surgery within 6 months of currently planned surgery
  • Unable to or declines study participation
  • Self-reported diagnosis of rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, ankylosing spondylitis
  • Arthroplasty surgery scheduled because of fracture, malignancy or infection
  • Scheduled for bilateral arthroplasty surgery
  • Scheduled to undergo hip or knee arthroplasty within 6 months of current knee arthroplasty
  • Score of 20 or greater on the PHQ-8 depression scale
  • Score of less than 3 on the six-item cognitive screener

Sites / Locations

  • Southern Illinois University
  • New York University
  • Duke University
  • Wake Forest University
  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Pain Coping Skills Training

Arthritis Education

Usual Care

Arm Description

The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.

The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.

Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.

Outcomes

Primary Outcome Measures

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
A self report scale that quantifies the extent of function limiting pain. The scale ranges from 0 to 20 with higher scores denoting worse activity related pain.

Secondary Outcome Measures

WOMAC Physical Function Scale
A self report scale that quantifies the extent of difficulty with everyday activity. The scale ranges from 0 to 68 with higher scores denoting greater difficulty with daily function.
0 to 10 Verbal Pain Rating Scale
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
Pain Catastrophizing Scale
A scale that quantifies the extent to which a participant catastrophizes about their pain. Score range from 0 to 52 with higher scores denoting greater pain catastrophizing.
Global Rating of Change Scale
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
Six-minute Walk Test
Distance walked in six minutes.
Short Physical Performance Battery
The Short Physical Performance Battery measures actual physical performance of four common daily physical activities including standing balance, single standing from a chair, repeated standing from a chair, and a 4 meter walk test. Scores range from 0 to 12 with higher scores indicating better physical performance.

Full Information

First Posted
June 13, 2012
Last Updated
October 18, 2018
Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT01620983
Brief Title
Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Acronym
KASTPain
Official Title
Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 27, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients undergoing knee replacement surgery and who have high levels of pain catastrophizing are at risk for poor outcome. The clinical trial is designed to determine if a pain coping skills training intervention delivered by physical therapists and supervised by psychologists is more effective at reducing pain and improving function and is more cost effective than arthritis education or usual care.
Detailed Description
Approximately 25% of patients following knee arthroplasty have disabling pain following apparently successful surgery. Recent research suggests that pain catastrophizing plays a key role in determining which patients with knee arthroplasty have a poor outcome. In addition to this evidence, a substantial literature suggests that pain coping skills training is effective for patients with chronic pain but the intervention has not been studied for surgical patients with severe arthritic knee pain. We designed the Knee Arthroplasty pain coping Skills Training (KASTPain) trial to address this research need. This Phase III three-arm randomized clinical trial seeks to combine a strong and diverse group of researchers to examine an important and understudied area in the joint arthroplasty literature. The KASTPain trial will be the first to examine the utility of a perioperative pain coping intervention for this substantial population of patients.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
402 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain Coping Skills Training
Arm Type
Experimental
Arm Description
The pain coping skills training will be delivered by physical therapists in eight one-hour sessions by telephone over a 2-month perioperative period. Patients will be taught a variety of skills designed to improve maladaptive pain related thoughts and actions to enhance recovery following arthroplasty.
Arm Title
Arthritis Education
Arm Type
Active Comparator
Arm Description
The eight one-hour perioperative arthritis education sessions will be delivered by nurse educators via telephone and will use a presentation and discussion format. Figures and discussion sessions will present information on the nature of arthritis, what to expect following knee arthroplasty, treatment of osteoarthritis, the role of exercise, joint protection and making future treatment decisions.
Arm Title
Usual Care
Arm Type
Other
Arm Description
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Intervention Type
Behavioral
Intervention Name(s)
Pain Coping Skills Training
Intervention Type
Behavioral
Intervention Name(s)
Arthritis Education
Intervention Type
Other
Intervention Name(s)
Usual Care
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
Description
A self report scale that quantifies the extent of function limiting pain. The scale ranges from 0 to 20 with higher scores denoting worse activity related pain.
Time Frame
twelve months
Secondary Outcome Measure Information:
Title
WOMAC Physical Function Scale
Description
A self report scale that quantifies the extent of difficulty with everyday activity. The scale ranges from 0 to 68 with higher scores denoting greater difficulty with daily function.
Time Frame
twelve months
Title
0 to 10 Verbal Pain Rating Scale
Description
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
Time Frame
twelve months
Title
Pain Catastrophizing Scale
Description
A scale that quantifies the extent to which a participant catastrophizes about their pain. Score range from 0 to 52 with higher scores denoting greater pain catastrophizing.
Time Frame
twelve months
Title
Global Rating of Change Scale
Description
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
Time Frame
twelve months
Title
Six-minute Walk Test
Description
Distance walked in six minutes.
Time Frame
twelve months
Title
Short Physical Performance Battery
Description
The Short Physical Performance Battery measures actual physical performance of four common daily physical activities including standing balance, single standing from a chair, repeated standing from a chair, and a 4 meter walk test. Scores range from 0 to 12 with higher scores indicating better physical performance.
Time Frame
twelve months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adults 45 years and older and capable of providing informed consent Diagnosis of osteoarthritis as determined by participating orthopaedic surgeons Scheduled for an elective unilateral total or unicompartmental knee arthroplasty no sooner than 1 week and no later than 8 weeks from the time of recruitment Score of greater than or = to 16 on the Pain Catastrophizing Scale Score of greater than or = to 5 on the WOMAC Pain Scale Able to read and speak English Exclusion Criteria: Scheduled for revision arthroplasty surgery Underwent contralateral knee arthroplasty surgery or hip arthroplasty surgery within 6 months of currently planned surgery Unable to or declines study participation Self-reported diagnosis of rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosis, ankylosing spondylitis Arthroplasty surgery scheduled because of fracture, malignancy or infection Scheduled for bilateral arthroplasty surgery Scheduled to undergo hip or knee arthroplasty within 6 months of current knee arthroplasty Score of 20 or greater on the PHQ-8 depression scale Score of less than 3 on the six-item cognitive screener
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel L. Riddle, Ph.D., PT
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern Illinois University
City
Springfield
State/Province
Illinois
ZIP/Postal Code
19679
Country
United States
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results of the main trial, after de-identification.
IPD Sharing Time Frame
Two years after publication of the primary findings to allow the investigators to publish secondary work from the trial. Data will no longer be available 5 years after publication of the primary findings.
IPD Sharing Access Criteria
Proposals must be submitted to the primary investigator who, along with the co-investigators will review the proposal. Access to the dataset will be granted based on scientific merit of the project, absence of overlap with other projects, and impact of the request on other planned uses of the dataset. A signed data user agreement will be required.
Citations:
PubMed Identifier
21530943
Citation
Riddle DL, Keefe FJ, Nay WT, McKee D, Attarian DE, Jensen MP. Pain coping skills training for patients with elevated pain catastrophizing who are scheduled for knee arthroplasty: a quasi-experimental study. Arch Phys Med Rehabil. 2011 Jun;92(6):859-65. doi: 10.1016/j.apmr.2011.01.003. Epub 2011 Apr 29.
Results Reference
background
PubMed Identifier
20670911
Citation
Riddle DL, Johnson RE, Jensen MP, Keefe FJ, Kroenke K, Bair MJ, Ang DC. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) instrument was useful for refining a randomized trial design: experiences from an investigative team. J Clin Epidemiol. 2010 Nov;63(11):1271-5. doi: 10.1016/j.jclinepi.2010.03.006. Epub 2010 Jun 17.
Results Reference
background
PubMed Identifier
29543659
Citation
Riddle DL, Jensen MP, Ang D, Slover J, Perera R, Dumenci L. Do Pain Coping and Pain Beliefs Associate With Outcome Measures Before Knee Arthroplasty in Patients Who Catastrophize About Pain? A Cross-sectional Analysis From a Randomized Clinical Trial. Clin Orthop Relat Res. 2018 Apr;476(4):778-786. doi: 10.1007/s11999.0000000000000001.
Results Reference
background
PubMed Identifier
29191188
Citation
Riddle DL, Slover J, Ang D, Perera RA, Dumenci L. Construct validation and correlates of preoperative expectations of postsurgical recovery in persons undergoing knee replacement: baseline findings from a randomized clinical trial. Health Qual Life Outcomes. 2017 Dec 1;15(1):232. doi: 10.1186/s12955-017-0810-x.
Results Reference
background
PubMed Identifier
22906061
Citation
Riddle DL, Keefe FJ, Ang D, J K, Dumenci L, Jensen MP, Bair MJ, Reed SD, Kroenke K. A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol. BMC Musculoskelet Disord. 2012 Aug 20;13:149. doi: 10.1186/1471-2474-13-149.
Results Reference
background
PubMed Identifier
32990311
Citation
Orndahl CM, Perera RA, Riddle DL. Associations Between Physical Therapy Visits and Pain and Physical Function After Knee Arthroplasty: A Cross-Lagged Panel Analysis of People Who Catastrophize About Pain Prior to Surgery. Phys Ther. 2021 Jan 4;101(1):pzaa182. doi: 10.1093/ptj/pzaa182.
Results Reference
derived
PubMed Identifier
32144884
Citation
Riddle DL, Slover J, Keefe FJ, Ang DC, Dumenci L, Perera RA. Racial Differences in Pain and Function Following Knee Arthroplasty: A Secondary Analysis From a Multicenter Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2021 Jun;73(6):810-817. doi: 10.1002/acr.24177.
Results Reference
derived

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Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial

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