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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Behavioral: Pain Coping Skills Training
* Behavioral: Arthritis Education
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain Coping Skills Training<br>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<br> <br> |
| Active Comparator: Arthritis Education<br>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<br> <br> |
| Other: Usual Care<br>Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. | Other: Usual Care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | twelve months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | twelve months | 
| 0 to 10 Verbal Pain Rating Scale | An 11 point verbal pain rating scale with higher scores denoting higher pain intensity. | 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. | twelve months | 
| Global Rating of Change Scale | 11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery. | twelve months | 
| Six-minute Walk Test | Distance walked in six minutes. | 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. | twelve months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arthroplasty, pain