Knee Arthroplasty Pain Coping Skills Training (KASTPain): A Randomized Trial (KASTPain)
2018年10月18日 更新者：Virginia Commonwealth University
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
402
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Illinois
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Springfield、Illinois、美国、19679
- Southern Illinois University
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New York
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New York、New York、美国、10003
- New York University
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North Carolina
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Durham、North Carolina、美国、27710
- Duke University
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Winston-Salem、North Carolina、美国、27157
- Wake Forest University
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Virginia
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Richmond、Virginia、美国、23298
- Virginia Commonwealth University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
45年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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有源比较器：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.
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其他：Usual Care
Patients randomly assigned to this arm will undergo usual care following knee arthroplasty.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Scale
大体时间：twelve months
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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.
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twelve months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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WOMAC Physical Function Scale
大体时间：twelve months
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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.
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twelve months
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0 to 10 Verbal Pain Rating Scale
大体时间：twelve months
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An 11 point verbal pain rating scale with higher scores denoting higher pain intensity.
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twelve months
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Pain Catastrophizing Scale
大体时间：twelve months
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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.
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twelve months
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Global Rating of Change Scale
大体时间：twelve months
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11 point scale ranging from -5 to +5 with higher scores denoting a greater recovery.
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twelve months
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Six-minute Walk Test
大体时间：twelve months
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Distance walked in six minutes.
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twelve months
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Short Physical Performance Battery
大体时间：twelve months
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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.
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twelve months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Daniel L. Riddle, Ph.D., PT、Virginia Commonwealth University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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, 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, 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, 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.
- 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.
- 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.
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年12月1日
初级完成 (实际的)
2017年6月27日
研究完成 (实际的)
2018年6月30日
研究注册日期
首次提交
2012年6月13日
首先提交符合 QC 标准的
2012年6月14日
首次发布 (估计)
2012年6月15日
研究记录更新
最后更新发布 (实际的)
2018年10月19日
上次提交的符合 QC 标准的更新
2018年10月18日
最后验证
2018年10月1日
更多信息
与本研究相关的术语
其他研究编号
- HM14326
- 1UM1AR062800-01 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Individual participant data that underlie the results of the main trial, after de-identification.
IPD 共享时间框架
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.
IPD 共享访问标准
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.
IPD 共享支持信息类型
- 研究方案
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.