Knee Osteoarthritis
Conditions
Keywords
arthroplasty, pain
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.
Interventions
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 0 to 10 Verbal Pain Rating Scale | twelve months | An 11 point verbal pain rating scale with higher scores denoting higher pain intensity. |
| 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. |
| 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. |
| Six-minute Walk Test | twelve months | Distance walked in six minutes. |
| 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. |
| Global Rating of Change Scale | twelve months | 11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Pain Coping Skills Training | 130 |
| 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.
Arthritis Education | 135 |
| Usual Care Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care | 137 |
| Total | 402 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 2 | 0 | 0 |
| Overall Study | Lost to Follow-up | 8 | 4 | 9 |
| Overall Study | Physician Decision | 3 | 10 | 5 |
| Overall Study | Withdrawal by Subject | 6 | 8 | 1 |
Baseline characteristics
| Characteristic | Pain Coping Skills Training | Usual Care | Total | Arthritis Education |
|---|---|---|---|---|
| Age, Continuous | 62.6 years STANDARD_DEVIATION 7.9 | 62.7 years STANDARD_DEVIATION 7.7 | 63.2 years STANDARD_DEVIATION 8 | 64.2 years STANDARD_DEVIATION 8.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 13 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 130 Participants | 383 Participants | 126 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 6 Participants | 4 Participants |
| Pain Catastrophizing Scale | 30.4 units on scale STANDARD_DEVIATION 9.6 | 29.7 units on scale STANDARD_DEVIATION 9.2 | 30.0 units on scale STANDARD_DEVIATION 9.3 | 30.0 units on scale STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 48 Participants | 47 Participants | 139 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) White | 78 Participants | 86 Participants | 247 Participants | 83 Participants |
| Sex: Female, Male Female | 94 Participants | 88 Participants | 267 Participants | 85 Participants |
| Sex: Female, Male Male | 36 Participants | 49 Participants | 135 Participants | 50 Participants |
| Short Physical Performance Battery | 7.6 units on scale STANDARD_DEVIATION 3.2 | 7.9 units on scale STANDARD_DEVIATION 2.6 | 7.8 units on scale STANDARD_DEVIATION 2.9 | 7.5 units on scale STANDARD_DEVIATION 2.9 |
| Six minute walk test | 305 meters STANDARD_DEVIATION 121 | 309 meters STANDARD_DEVIATION 106 | 297 meters STANDARD_DEVIATION 120 | 279 meters STANDARD_DEVIATION 132 |
| WOMAC Function Scale | 38.6 units on scale STANDARD_DEVIATION 11.8 | 36.0 units on scale STANDARD_DEVIATION 11.1 | 37.2 units on scale STANDARD_DEVIATION 11.6 | 37.1 units on scale STANDARD_DEVIATION 11.8 |
| WOMAC Pain Scale | 11.6 units on scale STANDARD_DEVIATION 3.1 | 11.4 units on scale STANDARD_DEVIATION 3.4 | 11.4 units on scale STANDARD_DEVIATION 3.4 | 11.3 units on scale STANDARD_DEVIATION 3.5 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 127 | 0 / 125 | 0 / 132 |
| other Total, other adverse events | 8 / 127 | 3 / 125 | 9 / 132 |
| serious Total, serious adverse events | 34 / 127 | 36 / 125 | 28 / 132 |
Outcome results
Primary
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
Population: Data from all subjects were included in primary and secondary analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale | 3.3 units on scale |
| Arthritis Education | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale | 3.0 units on scale |
| Usual Care | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale | 2.9 units on scale |
Secondary
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
Population: Data from all subjects were included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | 0 to 10 Verbal Pain Rating Scale | 1.8 units on scale |
| Arthritis Education | 0 to 10 Verbal Pain Rating Scale | 2.0 units on scale |
| Usual Care | 0 to 10 Verbal Pain Rating Scale | 1.7 units on scale |
Secondary
Global Rating of Change Scale
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
Time frame: twelve months
Population: Data from all subjects were analysed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | Global Rating of Change Scale | 3.6 units on scale |
| Arthritis Education | Global Rating of Change Scale | 3.8 units on scale |
| Usual Care | Global Rating of Change Scale | 4.1 units on scale |
Secondary
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
Population: Data from all subjects were included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | Pain Catastrophizing Scale | 6.8 units on scale |
| Arthritis Education | Pain Catastrophizing Scale | 7.2 units on scale |
| Usual Care | Pain Catastrophizing Scale | 6.1 units on scale |
Secondary
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.
Time frame: twelve months
Population: Data from all subjects were analysed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | Short Physical Performance Battery | 8.4 units on scale |
| Arthritis Education | Short Physical Performance Battery | 8.0 units on scale |
| Usual Care | Short Physical Performance Battery | 8.8 units on scale |
Secondary
Six-minute Walk Test
Distance walked in six minutes.
Time frame: twelve months
Population: Data from all subjects were analysed.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | Six-minute Walk Test | 366 meters |
| Arthritis Education | Six-minute Walk Test | 337 meters |
| Usual Care | Six-minute Walk Test | 363 meters |
Secondary
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
Population: Data from all subjects were included in the analyses.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Pain Coping Skills Training | WOMAC Physical Function Scale | 12.2 units on scale |
| Arthritis Education | WOMAC Physical Function Scale | 11.7 units on scale |
| Usual Care | WOMAC Physical Function Scale | 10.5 units on scale |