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

October 18, 2018 updated by: Virginia Commonwealth University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Springfield, Illinois, United States, 19679
        • Southern Illinois University
    • New York
      • New York, New York, United States, 10003
        • New York University
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pain Coping Skills Training
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.
Behavioral: Pain Coping Skills Training
Active Comparator: Arthritis Education
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.
Behavioral: Arthritis Education
Other: Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Other: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
Time Frame: twelve months
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.
twelve months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Physical Function Scale
Time Frame: twelve months
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.
twelve months
0 to 10 Verbal Pain Rating Scale
Time Frame: twelve months
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
twelve months
Pain Catastrophizing Scale
Time Frame: twelve months
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.
twelve months
Global Rating of Change Scale
Time Frame: twelve months
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
twelve months
Six-minute Walk Test
Time Frame: twelve months
Distance walked in six minutes.
twelve months
Short Physical Performance Battery
Time Frame: twelve months
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.
twelve months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Virginia Commonwealth University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Daniel L. Riddle, Ph.D., PT, Virginia Commonwealth University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

June 27, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

June 13, 2012

First Submitted That Met QC Criteria

June 14, 2012

First Posted (Estimate)

June 15, 2012

Study Record Updates

Last Update Posted (Actual)

October 19, 2018

Last Update Submitted That Met QC Criteria

October 18, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM14326
  • 1UM1AR062800-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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