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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01620983
Recruitment Status : Active, not recruiting
First Posted : June 15, 2012
Last Update Posted : September 12, 2017
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
Estimated Study Completion Date : June 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 ]

Secondary Outcome Measures :
  1. WOMAC Physical Function Scale [ Time Frame: two, six and twelve months ]
  2. 0 to 10 verbal pain rating scale [ Time Frame: two, six and twelve months ]
  3. Pain Catastrophizing Scale [ Time Frame: two, six and twelve months ]
  4. Global Rating of Change Scale [ Time Frame: two, six and twelve months ]
    11 point scale ranging from -5 to +5

  5. Patient Health Questionnaire (PHQ-8) Depression Scale [ Time Frame: two, six and twelve months ]
  6. EuroQol (EQ-5D-5L) [ Time Frame: two, six and twelve months ]
    health status measure to be used in cost analyses

  7. Healthcare related cost diary [ Time Frame: two, six and twelve months ]
    Cost diary completed by all patients and includes days lost from work, outpatient care and inpatient care

  8. WOMAC Pain Scale [ Time Frame: two months and six months ]
  9. Six-minute Walk Test [ Time Frame: twelve months ]
  10. Short Physical Performance Battery [ Time Frame: twelve months ]
    timed balance, chair stand and walking tests

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01620983

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University 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
Last Update Posted: September 12, 2017
Last Verified: September 2017

Keywords provided by Virginia Commonwealth University:

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