Trial Outcomes & Findings for Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial (NCT NCT01620983)
NCT ID: NCT01620983
Last Updated: 2018-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
402 participants
Primary outcome timeframe
twelve months
Results posted on
2018-10-19
Participant Flow
Participant milestones
| Measure |
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
|
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
|
Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Overall Study
STARTED
|
130
|
135
|
137
|
|
Overall Study
COMPLETED
|
111
|
113
|
122
|
|
Overall Study
NOT COMPLETED
|
19
|
22
|
15
|
Reasons for withdrawal
| Measure |
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
|
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
|
Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
4
|
9
|
|
Overall Study
Withdrawal by Subject
|
6
|
8
|
1
|
|
Overall Study
Death
|
2
|
0
|
0
|
|
Overall Study
Physician Decision
|
3
|
10
|
5
|
Baseline Characteristics
Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Baseline characteristics by cohort
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 7.9 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
62.7 years
STANDARD_DEVIATION 7.7 • n=5 Participants
|
63.2 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
94 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
267 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
135 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
127 Participants
n=5 Participants
|
126 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
383 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
48 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
139 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
247 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
WOMAC Pain Scale
|
11.6 units on scale
STANDARD_DEVIATION 3.1 • n=5 Participants
|
11.3 units on scale
STANDARD_DEVIATION 3.5 • n=7 Participants
|
11.4 units on scale
STANDARD_DEVIATION 3.4 • n=5 Participants
|
11.4 units on scale
STANDARD_DEVIATION 3.4 • n=4 Participants
|
|
WOMAC Function Scale
|
38.6 units on scale
STANDARD_DEVIATION 11.8 • n=5 Participants
|
37.1 units on scale
STANDARD_DEVIATION 11.8 • n=7 Participants
|
36.0 units on scale
STANDARD_DEVIATION 11.1 • n=5 Participants
|
37.2 units on scale
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Pain Catastrophizing Scale
|
30.4 units on scale
STANDARD_DEVIATION 9.6 • n=5 Participants
|
30.0 units on scale
STANDARD_DEVIATION 9.2 • n=7 Participants
|
29.7 units on scale
STANDARD_DEVIATION 9.2 • n=5 Participants
|
30.0 units on scale
STANDARD_DEVIATION 9.3 • n=4 Participants
|
|
Six minute walk test
|
305 meters
STANDARD_DEVIATION 121 • n=5 Participants
|
279 meters
STANDARD_DEVIATION 132 • n=7 Participants
|
309 meters
STANDARD_DEVIATION 106 • n=5 Participants
|
297 meters
STANDARD_DEVIATION 120 • n=4 Participants
|
|
Short Physical Performance Battery
|
7.6 units on scale
STANDARD_DEVIATION 3.2 • n=5 Participants
|
7.5 units on scale
STANDARD_DEVIATION 2.9 • n=7 Participants
|
7.9 units on scale
STANDARD_DEVIATION 2.6 • n=5 Participants
|
7.8 units on scale
STANDARD_DEVIATION 2.9 • n=4 Participants
|
PRIMARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were included in primary and secondary analyses.
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.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
|
3.3 units on scale
Interval 2.5 to 4.2
|
3.0 units on scale
Interval 2.1 to 3.8
|
2.9 units on scale
Interval 2.0 to 3.8
|
SECONDARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were included in the analyses.
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.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
WOMAC Physical Function Scale
|
12.2 units on scale
Interval 9.0 to 15.4
|
11.7 units on scale
Interval 8.6 to 14.9
|
10.5 units on scale
Interval 7.4 to 13.6
|
SECONDARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were included in the analyses.
An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
0 to 10 Verbal Pain Rating Scale
|
1.8 units on scale
Interval 1.2 to 2.4
|
2.0 units on scale
Interval 1.3 to 2.6
|
1.7 units on scale
Interval 1.1 to 2.2
|
SECONDARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were included in the analyses.
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.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Pain Catastrophizing Scale
|
6.8 units on scale
Interval 4.0 to 9.6
|
7.2 units on scale
Interval 4.0 to 10.0
|
6.1 units on scale
Interval 3.4 to 8.9
|
SECONDARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were analysed.
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Global Rating of Change Scale
|
3.6 units on scale
Interval 3.1 to 4.2
|
3.8 units on scale
Interval 3.3 to 4.3
|
4.1 units on scale
Interval 3.6 to 4.6
|
SECONDARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were analysed.
Distance walked in six minutes.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Six-minute Walk Test
|
366 meters
Interval 341.0 to 391.0
|
337 meters
Interval 313.0 to 362.0
|
363 meters
Interval 340.0 to 387.0
|
SECONDARY outcome
Timeframe: twelve monthsPopulation: Data from all subjects were analysed.
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.
Outcome measures
| Measure |
Pain Coping Skills Training
n=130 Participants
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
|
Arthritis Education
n=135 Participants
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
|
Usual Care
n=137 Participants
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Short Physical Performance Battery
|
8.4 units on scale
Interval 7.6 to 9.1
|
8.0 units on scale
Interval 7.2 to 8.7
|
8.8 units on scale
Interval 7.8 to 9.4
|
Adverse Events
Pain Coping Skills Training
Serious events: 34 serious events
Other events: 8 other events
Deaths: 2 deaths
Arthritis Education
Serious events: 36 serious events
Other events: 3 other events
Deaths: 0 deaths
Usual Care
Serious events: 28 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pain Coping Skills Training
n=127 participants at risk
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
|
Arthritis Education
n=125 participants at risk
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
|
Usual Care
n=132 participants at risk
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Blood and lymphatic system disorders
venous thromboembolism
|
2.4%
3/127 • Number of events 3 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
1.6%
2/125 • Number of events 2 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
2.3%
3/132 • Number of events 3 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
infection of knee
|
1.6%
2/127 • Number of events 2 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.80%
1/125 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
1.5%
2/132 • Number of events 2 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
Hospitlilization
|
0.00%
0/127 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
1.6%
2/125 • Number of events 2 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
3.8%
5/132 • Number of events 5 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Nervous system disorders
Hospitalization for psychological distress
|
0.00%
0/127 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.80%
1/125 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.76%
1/132 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
Revision of index knee
|
2.4%
3/127 • Number of events 3 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
2.4%
3/125 • Number of events 3 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.76%
1/132 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
Manipulation of index knee
|
5.5%
7/127 • Number of events 7 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
5.6%
7/125 • Number of events 7 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
2.3%
3/132 • Number of events 3 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
Contralateral knee replacement
|
9.4%
12/127 • Number of events 12 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
10.4%
13/125 • Number of events 13 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
5.3%
7/132 • Number of events 7 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Surgical and medical procedures
Other hospitalization
|
5.5%
7/127 • Number of events 7 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
5.6%
7/125 • Number of events 7 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
5.3%
7/132 • Number of events 7 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
Other adverse events
| Measure |
Pain Coping Skills Training
n=127 participants at risk
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
|
Arthritis Education
n=125 participants at risk
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
|
Usual Care
n=132 participants at risk
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
Usual Care
|
|---|---|---|---|
|
Nervous system disorders
psychological distress
|
3.9%
5/127 • Number of events 5 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
1.6%
2/125 • Number of events 2 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
6.1%
8/132 • Number of events 8 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Cardiac disorders
shortness of breath
|
0.79%
1/127 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.00%
0/125 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.00%
0/132 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
orthopaedic injury to the knee
|
0.79%
1/127 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.00%
0/125 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.76%
1/132 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
|
Musculoskeletal and connective tissue disorders
Emergency room visity for knee pain
|
0.79%
1/127 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.80%
1/125 • Number of events 1 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
0.00%
0/132 • Adverse events were collected both from the participants, and from the medical record over the time period from the time of surgery to 12 months following surgery.
The time frame has not changed from the original definition. The sample size for persons experience adverse events or serious adverse events is different from baseline consent because 18 subjects who consented to participate did not have knee replacement surgery and therefore were not considered for adverse events.Of the 18, 5 were randomly assigned to the usual care arm at baseline, 10 were assigned to the arthritis education arm and 3 were assigned to the pain coping skills training arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place