N/A
N=402
Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Knee Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT01620983 ↗Enrolled (actual)
402
Serious AEs
25.5%
Results posted
Oct 2018
Primary outcome: Primary: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale — 3.3; 3.0; 2.9 units on scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pain Coping Skills Training (Behavioral); Arthritis Education (Behavioral); Usual Care (Other)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale |
3.3; 3.0; 2.9 | — |
| SECONDARY WOMAC Physical Function Scale |
12.2; 11.7; 10.5 | — |
| SECONDARY 0 to 10 Verbal Pain Rating Scale |
1.8; 2.0; 1.7 | — |
| SECONDARY Pain Catastrophizing Scale |
6.8; 7.2; 6.1 | — |
| SECONDARY Global Rating of Change Scale |
3.6; 3.8; 4.1 | — |
| SECONDARY Six-minute Walk Test |
366; 337; 363 | — |
| SECONDARY Short Physical Performance Battery |
8.4; 8.0; 8.8 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01620983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.