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

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ClinicalTrials.gov Identifier: NCT01620983
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Virginia Commonwealth University

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Behavioral: Pain Coping Skills Training Behavioral: Arthritis Education Other: Usual Care Not Applicable

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  (Clinical Trial)
Actual Enrollment : 402 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Study Start Date : December 2012
Actual Primary Completion Date : June 27, 2017
Actual Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine


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
Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Other: Usual Care



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Global Rating of Change Scale [ Time Frame: twelve months ]
    11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.

  5. Six-minute Walk Test [ Time Frame: twelve months ]
    Distance walked in six minutes.

  6. 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.



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01620983


Locations
United States, Illinois
Southern Illinois University
Springfield, Illinois, United States, 19679
United States, New York
New York University
New York, New York, United States, 10003
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27157
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Daniel L. Riddle, Ph.D., PT Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:

Publications:

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01620983     History of Changes
Other Study ID Numbers: HM14326
1UM1AR062800-01 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2012    Key Record Dates
Results First Posted: October 19, 2018
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results of the main trial, after de-identification.
Supporting Materials: Study Protocol
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.
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.

Keywords provided by Virginia Commonwealth University:
arthroplasty
pain

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases