Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
- Conditions
- Knee Osteoarthritis
- Interventions
- Behavioral: Pain Coping Skills TrainingBehavioral: Arthritis EducationOther: Usual Care
- Registration Number
- NCT01620983
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 402
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pain Coping Skills Training 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. Arthritis Education 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. Usual Care Usual Care Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
- Primary Outcome Measures
Name Time Method Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale 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
Name Time Method Six-minute Walk Test twelve months Distance walked in six minutes.
0 to 10 Verbal Pain Rating Scale twelve months An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
WOMAC Physical Function Scale 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.
Pain Catastrophizing Scale 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.
Global Rating of Change Scale twelve months 11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
Short Physical Performance Battery 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.
Trial Locations
- Locations (5)
New York University
🇺🇸New York, New York, United States
Duke University
🇺🇸Durham, North Carolina, United States
Wake Forest University
🇺🇸Winston-Salem, North Carolina, United States
Southern Illinois University
🇺🇸Springfield, Illinois, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States