Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Sponsor
Virginia Commonwealth University (Other)
Overall Status
Completed
CT.gov ID
NCT01620983
Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) (NIH)
402
5
3
66.9
80.4
1.2
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial
Study Start Date
:
Dec 1, 2012
Actual Primary Completion Date
:
Jun 27, 2017
Actual Study Completion Date
:
Jun 30, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Behavioral: Pain Coping Skills Training
|
| Active Comparator: 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. |
Behavioral: Arthritis Education
|
| Other: Usual Care Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. |
Other: Usual Care
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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.
- Global Rating of Change Scale [twelve months]
11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
All
Accepts 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Southern Illinois University | Springfield | Illinois | United States | 19679 |
| 2 | New York University | New York | New York | United States | 10003 |
| 3 | Duke University | Durham | North Carolina | United States | 27710 |
| 4 | Wake Forest University | Winston-Salem | North Carolina | United States | 27157 |
| 5 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
- Principal Investigator: Daniel L. Riddle, Ph.D., PT, Virginia Commonwealth University
Study Documents (Full-Text)
More Information
Publications
- Riddle DL, Jensen MP, Ang D, Slover J, Perera R, Dumenci L. Do Pain Coping and Pain Beliefs Associate With Outcome Measures Before Knee Arthroplasty in Patients Who Catastrophize About Pain? A Cross-sectional Analysis From a Randomized Clinical Trial. Clin Orthop Relat Res. 2018 Apr;476(4):778-786. doi: 10.1007/s11999.0000000000000001.
- Riddle DL, Johnson RE, Jensen MP, Keefe FJ, Kroenke K, Bair MJ, Ang DC. The Pragmatic-Explanatory Continuum Indicator Summary (PRECIS) instrument was useful for refining a randomized trial design: experiences from an investigative team. J Clin Epidemiol. 2010 Nov;63(11):1271-5. doi: 10.1016/j.jclinepi.2010.03.006. Epub 2010 Jun 17.
- Riddle DL, Keefe FJ, Ang D, J K, Dumenci L, Jensen MP, Bair MJ, Reed SD, Kroenke K. A phase III randomized three-arm trial of physical therapist delivered pain coping skills training for patients with total knee arthroplasty: the KASTPain protocol. BMC Musculoskelet Disord. 2012 Aug 20;13:149. doi: 10.1186/1471-2474-13-149.
- Riddle DL, Keefe FJ, Nay WT, McKee D, Attarian DE, Jensen MP. Pain coping skills training for patients with elevated pain catastrophizing who are scheduled for knee arthroplasty: a quasi-experimental study. Arch Phys Med Rehabil. 2011 Jun;92(6):859-65. doi: 10.1016/j.apmr.2011.01.003. Epub 2011 Apr 29.
- Riddle DL, Slover J, Ang D, Perera RA, Dumenci L. Construct validation and correlates of preoperative expectations of postsurgical recovery in persons undergoing knee replacement: baseline findings from a randomized clinical trial. Health Qual Life Outcomes. 2017 Dec 1;15(1):232. doi: 10.1186/s12955-017-0810-x.
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01620983
Other Study ID Numbers:
- HM14326
- 1UM1AR062800-01
First Posted:
Jun 15, 2012
Last Update Posted:
Oct 19, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Virginia Commonwealth University
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Period Title: Overall Study | |||
| STARTED | 130 | 135 | 137 |
| COMPLETED | 111 | 113 | 122 |
| NOT COMPLETED | 19 | 22 | 15 |
Baseline Characteristics
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care | Total |
|---|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care | Total of all reporting groups |
| Overall Participants | 130 | 135 | 137 | 402 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
62.6
(7.9)
|
64.2
(8.5)
|
62.7
(7.7)
|
63.2
(8.0)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
94
72.3%
|
85
63%
|
88
64.2%
|
267
66.4%
|
| Male |
36
27.7%
|
50
37%
|
49
35.8%
|
135
33.6%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
3
2.3%
|
5
3.7%
|
5
3.6%
|
13
3.2%
|
| Not Hispanic or Latino |
127
97.7%
|
126
93.3%
|
130
94.9%
|
383
95.3%
|
| Unknown or Not Reported |
0
0%
|
4
3%
|
2
1.5%
|
6
1.5%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
2
1.5%
|
4
3%
|
2
1.5%
|
8
2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
48
36.9%
|
44
32.6%
|
47
34.3%
|
139
34.6%
|
| White |
78
60%
|
83
61.5%
|
86
62.8%
|
247
61.4%
|
| More than one race |
2
1.5%
|
1
0.7%
|
1
0.7%
|
4
1%
|
| Unknown or Not Reported |
0
0%
|
3
2.2%
|
1
0.7%
|
4
1%
|
| WOMAC Pain Scale (units on scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on scale] |
11.6
(3.1)
|
11.3
(3.5)
|
11.4
(3.4)
|
11.4
(3.4)
|
| WOMAC Function Scale (units on scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on scale] |
38.6
(11.8)
|
37.1
(11.8)
|
36.0
(11.1)
|
37.2
(11.6)
|
| Pain Catastrophizing Scale (units on scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on scale] |
30.4
(9.6)
|
30.0
(9.2)
|
29.7
(9.2)
|
30.0
(9.3)
|
| Six minute walk test (meters) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [meters] |
305
(121)
|
279
(132)
|
309
(106)
|
297
(120)
|
| Short Physical Performance Battery (units on scale) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [units on scale] |
7.6
(3.2)
|
7.5
(2.9)
|
7.9
(2.6)
|
7.8
(2.9)
|
Outcome Measures
| Title | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were included in primary and secondary analyses. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [units on scale] |
3.3
|
3.0
|
2.9
|
| Title | WOMAC Physical Function Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were included in the analyses. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [units on scale] |
12.2
|
11.7
|
10.5
|
| Title | 0 to 10 Verbal Pain Rating Scale |
|---|---|
| Description | An 11 point verbal pain rating scale with higher scores denoting higher pain intensity. |
| Time Frame | twelve months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were included in the analyses. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [units on scale] |
1.8
|
2.0
|
1.7
|
| Title | Pain Catastrophizing Scale |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were included in the analyses. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [units on scale] |
6.8
|
7.2
|
6.1
|
| Title | Global Rating of Change Scale |
|---|---|
| Description | 11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery. |
| Time Frame | twelve months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were analysed. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [units on scale] |
3.6
|
3.8
|
4.1
|
| Title | Six-minute Walk Test |
|---|---|
| Description | Distance walked in six minutes. |
| Time Frame | twelve months |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were analysed. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [meters] |
366
|
337
|
363
|
| Title | Short Physical Performance Battery |
|---|---|
| Description | 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Data from all subjects were analysed. |
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care |
|---|---|---|---|
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Measure Participants | 130 | 135 | 137 |
| Mean (95% Confidence Interval) [units on scale] |
8.4
|
8.0
|
8.8
|
Adverse Events
| Time Frame | 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. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | 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. | |||||
| Arm/Group Title | Pain Coping Skills Training | Arthritis Education | Usual Care | |||
| Arm/Group Description | 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 | 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 | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care | |||
All Cause Mortality |
||||||
| Pain Coping Skills Training | Arthritis Education | Usual Care | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/127 (1.6%) | 0/125 (0%) | 0/132 (0%) | |||
Serious Adverse Events |
||||||
| Pain Coping Skills Training | Arthritis Education | Usual Care | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 34/127 (26.8%) | 36/125 (28.8%) | 28/132 (21.2%) | |||
| Blood and lymphatic system disorders | ||||||
| venous thromboembolism | 3/127 (2.4%) | 3 | 2/125 (1.6%) | 2 | 3/132 (2.3%) | 3 |
| Musculoskeletal and connective tissue disorders | ||||||
| infection of knee | 2/127 (1.6%) | 2 | 1/125 (0.8%) | 1 | 2/132 (1.5%) | 2 |
| Hospitlilization | 0/127 (0%) | 0 | 2/125 (1.6%) | 2 | 5/132 (3.8%) | 5 |
| Revision of index knee | 3/127 (2.4%) | 3 | 3/125 (2.4%) | 3 | 1/132 (0.8%) | 1 |
| Manipulation of index knee | 7/127 (5.5%) | 7 | 7/125 (5.6%) | 7 | 3/132 (2.3%) | 3 |
| Contralateral knee replacement | 12/127 (9.4%) | 12 | 13/125 (10.4%) | 13 | 7/132 (5.3%) | 7 |
| Nervous system disorders | ||||||
| Hospitalization for psychological distress | 0/127 (0%) | 0 | 1/125 (0.8%) | 1 | 1/132 (0.8%) | 1 |
| Surgical and medical procedures | ||||||
| Other hospitalization | 7/127 (5.5%) | 7 | 7/125 (5.6%) | 7 | 7/132 (5.3%) | 7 |
Other (Not Including Serious) Adverse Events |
||||||
| Pain Coping Skills Training | Arthritis Education | Usual Care | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 8/127 (6.3%) | 3/125 (2.4%) | 9/132 (6.8%) | |||
| Cardiac disorders | ||||||
| shortness of breath | 1/127 (0.8%) | 1 | 0/125 (0%) | 0 | 0/132 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| orthopaedic injury to the knee | 1/127 (0.8%) | 1 | 0/125 (0%) | 0 | 1/132 (0.8%) | 1 |
| Emergency room visity for knee pain | 1/127 (0.8%) | 1 | 1/125 (0.8%) | 1 | 0/132 (0%) | 0 |
| Nervous system disorders | ||||||
| psychological distress | 5/127 (3.9%) | 5 | 2/125 (1.6%) | 2 | 8/132 (6.1%) | 8 |
Limitations/Caveats
No limitations were noted.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Daniel L. Riddle |
|---|---|
| Organization | Virginia Commonwealth University |
| Phone | 804-828-0234 |
| dlriddle@vcu.edu |
Responsible Party:
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01620983
Other Study ID Numbers:
- HM14326
- 1UM1AR062800-01
First Posted:
Jun 15, 2012
Last Update Posted:
Oct 19, 2018
Last Verified:
Oct 1, 2018