Improving Functioning in Persons With Chronic Pain Post-SCI Through Virtual Classroom Education
2020年5月8日 更新者：Kessler Foundation
Chronic pain (pain that is that is present for a long period of time) is very common among people with spinal cord injury (SCI).
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
研究概览
详细说明
Chronic pain (pain that is present for a long period of time) is common among people with spinal cord injury (SCI). The pain is often severe and can affect daily activities. Unfortunately, common treatments such as medications provide incomplete relief from chronic pain. Thus, persons with SCI have to find alternate ways to live a happy, healthy, and productive life, even with some pain.
The purpose of this study is to compare how well two different web-based education programs reduce the level to which chronic pain interferes with daily activities and well-being.
研究类型
介入性
注册 (实际的)
75
阶段
- 阶段2
- 阶段1
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
-
-
New Jersey
-
West Orange、New Jersey、美国、07052
- Kessler Foundation
-
-
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
18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:
- SCI for at least one year
- Chronic pain for at least three months that is moderate to severe
- Fluent in English
- Not currently starting a new pain treatment or changing a previous pain treatment
Exclusion Criteria:
- Lack of access to a computer with high-speed internet access, at home or another location
- Cancer or conditions that may worsen over time (such as multiple sclerosis, Parkinson Disease, Alzheimer's disease) and may affect physical or mental functioning
- Significant difficulties with learning or memory
- Previous participation in a health and function education program specifically designed for people with chronic pain and SCI
- Inability to understand English well
- Other conditions not related to SCI that cause pain (such as fibromyalgia)
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 |
|---|---|
|
实验性的：Web-Based Education Program Type 1
The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.
|
The classes will discuss topics related to health and functioning of people with spinal cord injury.
During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group.
Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
|
|
实验性的：Web-Based Education Program Type 2
The education program involves ten weeks of web-based classes (1.5 hours per class) given once per week with daily homework assignments of approximately 30 minutes per day.
|
The classes will discuss topics related to health and functioning of people with spinal cord injury.
During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group.
Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
|
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 |
|---|---|---|
|
Change in level of pain interference with activities, measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS)
大体时间：Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
|
The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS).
The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life.
The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
|
Average of scores obtained during baseline (Week 1 and Week 2) compared to scores obtained during Week 12 (the week in which the program is completed)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in pain intensity rated on a 0-10 numerical rating scale
大体时间：Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
Pain intensity will be rated on a 0-10 numerical rating scale (0="no pain" and 10="pain as bad as you can imagine").
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
|
Change in Brief Patient Health Questionnaire scores
大体时间：Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
The Brief Patient Health Questionnaire will be used to assess changes in mental health before and after participation in the education program.
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
|
Change in Mental Health Subscale of the SF-36 scores
大体时间：Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
The Mental Health Subscale of the SF-36 will be used to assess changes in mental health and well-being before and after participation in the education program.
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
|
Change in Survey of Pain Attitudes scores
大体时间：Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
The Survey of Pain Attitudes will be used to assess thoughts and feelings about pain before and after participation in the education program.
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
|
Change in Coping Strategies Questionnaire scores
大体时间：Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
The Coping Strategies Questionnaire will be used to assess thoughts and feelings about pain before and after participation in the education program.
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
|
Change in Chronic Pain Acceptance Questionnaire scores
大体时间：Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
The Chronic Pain Acceptance Questionnaire will be used to assess thoughts and beliefs about pain before and after participation in the education program.
|
Week 12 versus baseline; 3, 6, 12 months post-intervention versus baseline
|
|
Pain interference with activities, measured with the Life Interference Subscale of the Change in Multidimensional Pain Inventory (MPI-LIS) scores
大体时间：3, 6, 12 months post-intervention versus baseline
|
The extent to which pain interferes with daily activities will be measured with the Life Interference Subscale of the Multidimensional Pain Inventory (MPI-LIS).
The MPI-LIS is a self-report of extent of interference of pain with life activities and the enjoyment of life.
The subscale will be modified to remove two items related to work, as recommended based on a factor analysis of the subscale in persons with SCI.
|
3, 6, 12 months post-intervention versus baseline
|
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。
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
2015年3月1日
初级完成 (实际的)
2018年12月31日
研究完成 (实际的)
2019年12月31日
研究注册日期
首次提交
2015年2月11日
首先提交符合 QC 标准的
2015年9月25日
首次发布 (估计)
2015年9月28日
研究记录更新
最后更新发布 (实际的)
2020年5月12日
上次提交的符合 QC 标准的更新
2020年5月8日
最后验证
2020年5月1日
更多信息
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.