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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Virginia Commonwealth University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01620983
First received: June 13, 2012
Last updated: August 15, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Knee Osteoarthritis
Behavioral: Pain Coping Skills Training
Behavioral: Arthritis Education
Other: Usual Care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • WOMAC Pain Scale [ Time Frame: twelve months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • WOMAC Physical Function Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
  • 0 to 10 verbal pain rating scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
  • Pain Catastrophizing Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
  • Global Rating of Change Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
    11 point scale ranging from -5 to +5

  • PHQ-8 Depression Scale [ Time Frame: two, six and twelve months ] [ Designated as safety issue: Yes ]
  • EQ-5D-5L [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
    health status measure to be used in cost analyses

  • Healthcare related cost diary [ Time Frame: two, six and twelve months ] [ Designated as safety issue: No ]
    Cost diary completed by all patients and includes days lost from work, outpatient care and inpatient care

  • WOMAC Pain Scale [ Time Frame: two months and six months ] [ Designated as safety issue: No ]
  • Six-minute Walk Test [ Time Frame: twelve months ] [ Designated as safety issue: No ]
  • Short Physical Performance Battery [ Time Frame: twelve months ] [ Designated as safety issue: No ]
    timed balance, chair stand and walking tests


Estimated Enrollment: 402
Study Start Date: December 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01620983

Contacts
Contact: Daniel L Riddle, PhD, PT 804-828-0234 dlriddle@vcu.edu

Locations
United States, Illinois
Southern Illinois University Recruiting
Springfield, Illinois, United States, 19679
Contact: Khaled J Saleh, MD, MSc    217-545-7768    ksaleh@siumed.edu   
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Francis J Keefe, PhD    919-416-3401    keefe003@mc.duke.edu   
Wake Forest University Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Dennis Ang, MD    336-713-4264    dang@wakehealth.edu   
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Daniel L Riddle, PhD, PT    804-828-0234    dlriddle@vcu.edu   
Sub-Investigator: Levent Dumenci, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Daniel L. Riddle, Ph.D., PT Virginia Commonwealth University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01620983     History of Changes
Other Study ID Numbers: 1UM1AR062800-01
Study First Received: June 13, 2012
Last Updated: August 15, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Virginia Commonwealth University:
arthroplasty
pain

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

ClinicalTrials.gov processed this record on October 19, 2014