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| ID | Type | Description | Link |
|---|---|---|---|
| 1UM1AR062800-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pain Coping Skills Training | Experimental | 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. |
|
| Arthritis Education | Active Comparator | 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. |
|
| Usual Care | Other | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pain Coping Skills Training | Behavioral |
| ||
| Arthritis Education |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel L. Riddle, Ph.D., PT | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Illinois University | Springfield | Illinois | 19679 | United States | ||
| New York University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21530943 | Background | 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. | |
| 20670911 | Background | 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. |
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Individual participant data that underlie the results of the main trial, after de-identification.
Two years after publication of the primary findings to allow the investigators to publish secondary work from the trial. Data will no longer be available 5 years after publication of the primary findings.
Proposals must be submitted to the primary investigator who, along with the co-investigators will review the proposal. Access to the dataset will be granted based on scientific merit of the project, absence of overlap with other projects, and impact of the request on other planned uses of the dataset. A signed data user agreement will be required.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Usual Care | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data from all subjects were included in primary and secondary analyses. | Posted | Mean | 95% Confidence Interval | units on scale | twelve months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| venous thromboembolism | Blood and lymphatic system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| psychological distress | Nervous system disorders | Systematic Assessment |
No limitations were noted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daniel L. Riddle | Virginia Commonwealth University | 804-828-0234 | dlriddle@vcu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2012 | Aug 14, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D010146 | Pain |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Behavioral |
|
| Usual Care | Other |
|
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 |
| New York |
| New York |
| 10003 |
| United States |
| Duke University | Durham | North Carolina | 27710 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| 29543659 | Background | 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. |
| 29191188 | Background | 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. |
| 22906061 | Background | 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. |
| 32990311 | Derived | Orndahl CM, Perera RA, Riddle DL. Associations Between Physical Therapy Visits and Pain and Physical Function After Knee Arthroplasty: A Cross-Lagged Panel Analysis of People Who Catastrophize About Pain Prior to Surgery. Phys Ther. 2021 Jan 4;101(1):pzaa182. doi: 10.1093/ptj/pzaa182. |
| 32144884 | Derived | Riddle DL, Slover J, Keefe FJ, Ang DC, Dumenci L, Perera RA. Racial Differences in Pain and Function Following Knee Arthroplasty: A Secondary Analysis From a Multicenter Randomized Clinical Trial. Arthritis Care Res (Hoboken). 2021 Jun;73(6):810-817. doi: 10.1002/acr.24177. |
| Death |
|
| Physician Decision |
|
| BG001 |
| 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 |
| BG002 | Usual Care | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| 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. | Mean | Standard Deviation | units on scale |
|
| WOMAC Function Scale | A self report scale that quantifies the extent of difficulty with daily function. The scale ranges from 0 to 68 with higher scores denoting more difficult daily function. | Mean | Standard Deviation | units on scale |
|
| 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 | Mean | Standard Deviation | units on scale |
|
| Six minute walk test | Mean | Standard Deviation | meters |
|
| 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. | Mean | Standard Deviation | units on scale |
|
| 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 |
| OG002 | Usual Care | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care |
|
|
| 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. | Data from all subjects were included in the analyses. | Posted | Mean | 95% Confidence Interval | units on scale | twelve months |
|
|
|
| Secondary | 0 to 10 Verbal Pain Rating Scale | An 11 point verbal pain rating scale with higher scores denoting higher pain intensity. | Data from all subjects were included in the analyses. | Posted | Mean | 95% Confidence Interval | units on scale | twelve months |
|
|
|
| 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. | Data from all subjects were included in the analyses. | Posted | Mean | 95% Confidence Interval | units on scale | twelve months |
|
|
|
| Secondary | Global Rating of Change Scale | 11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery. | Data from all subjects were analysed. | Posted | Mean | 95% Confidence Interval | units on scale | twelve months |
|
|
|
| Secondary | Six-minute Walk Test | Distance walked in six minutes. | Data from all subjects were analysed. | Posted | Mean | 95% Confidence Interval | meters | twelve months |
|
|
|
| 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. | Data from all subjects were analysed. | Posted | Mean | 95% Confidence Interval | units on scale | twelve months |
|
|
|
| 2 |
| 127 |
| 34 |
| 127 |
| 8 |
| 127 |
| EG001 | 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 | 0 | 125 | 36 | 125 | 3 | 125 |
| EG002 | Usual Care | Patients randomly assigned to this arm will undergo usual care following knee arthroplasty. Usual Care | 0 | 132 | 28 | 132 | 9 | 132 |
| infection of knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Hospitlilization | Musculoskeletal and connective tissue disorders | Systematic Assessment | Other hospitalization other than the index knee |
|
| Hospitalization for psychological distress | Nervous system disorders | Systematic Assessment |
|
| Revision of index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Manipulation of index knee | Musculoskeletal and connective tissue disorders | Systematic Assessment | Due to stiffness |
|
| Contralateral knee replacement | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Other hospitalization | Surgical and medical procedures | Systematic Assessment | Non-musculoskeletal admissions |
|
| shortness of breath | Cardiac disorders | Systematic Assessment |
|
| orthopaedic injury to the knee | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Emergency room visity for knee pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |