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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
402
Southern Illinois University
Springfield, Illinois, United States
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
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
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.
Time frame: twelve months
WOMAC Physical Function Scale
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.
Time frame: twelve months
0 to 10 Verbal Pain Rating Scale
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
Time frame: twelve months
Pain Catastrophizing Scale
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.
Time frame: twelve months
Global Rating of Change Scale
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
Time frame: twelve months
Six-minute Walk Test
Distance walked in six minutes.
Time frame: twelve months
Short Physical Performance Battery
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Virginia Commonwealth University
Richmond, Virginia, United States
Time frame: twelve months