Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)
2019年7月3日 更新者：Zealand University Hospital
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
This study aims to investigate the cognitive function of patients in the opioid reduction programme at the multidisciplinary pain centre at Zealand University Hospital Køge.
The patients will be tested before, halfway through, and after the programme.
研究概览
详细说明
The number of patients with chronic non-malignant pain is high and constant. An estimated 3-5% of the population use opioids daily. These patients have a lower quality of life and a higher use of healthcare services.
This leads to enormous costs, both human and economic. Many patients lose their ability to work, not only because of the pain, but also because of their treatment.
For a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce.
A rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids.
The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain.
Many patients are at first reluctant to start the reduction programme. Mostly because the patients may not be aware of the effects, the drugs are having on them. Many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects.
The investigators wanted to test the cognitive function of patients before, during and after opioid reduction. The results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.
研究类型
观察性的
注册 (实际的)
50
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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Holbæk、丹麦、4300
- Holbæk Hospital
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Køge、丹麦、4600
- Zealand University Hospital
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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
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
取样方法
非概率样本
研究人群
Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge
描述
Inclusion Criteria:
- Patients > 18 years of age and able to provide a written consent
- Participating in the opioid reduction programme
Exclusion Criteria:
- Not able to speak and understand Danish
- Patients suffering from dementia or psychosis
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
- 观测模型：队列
- 时间观点：预期
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 |
|---|---|---|
|
Cognitive function before opioid reduction
大体时间：At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
|
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cognitive function at halfway point
大体时间：When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
|
When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
|
Cognitive function at end of reduction
大体时间：When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
|
When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
|
Executive function before opioid reduction
大体时间：At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
Executive function measured by Trail making test A and B
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
|
Executive function at halfway point
大体时间：When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
Executive function measured by Trail making test A and B
|
When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
|
Executive function at end of reduction
大体时间：When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
Executive function measured by Trail making test A and B
|
When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
|
Morphine use before reduction
大体时间：At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
|
Morphine equivalents before reduction
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At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
|
|
Morphine use after reduction
大体时间：At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
Morphine equivalents after reduction
|
At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
|
Use of other analgesics before reduction
大体时间：At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
Use of any other analgesic
|
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
|
Use of other analgesics at halfway point
大体时间：When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
Use of any other analgesic
|
When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
|
Use of other analgesics after reduction
大体时间：At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
Use of any other analgesic
|
At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
|
Quality of life before reduction
大体时间：At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
Quality of life measured by SF36
|
At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
|
Quality of life at halfway point
大体时间：When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
Quality of life measured by SF36
|
When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
|
Quality of life at end of reduction
大体时间：At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
Quality of life measured by SF36
|
At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
|
Risk of anxiety and depression before reduction
大体时间：At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
Risk of anxiety and depression measured by Hospital anxiety and depression scale
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
|
|
Risk of anxiety and depression at halfway point
大体时间：When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
Risk of anxiety and depression measured by Hospital anxiety and depression scale
|
When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months)
|
|
Risk of anxiety and depression at end of reduction
大体时间：At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
Risk of anxiety and depression measured by Hospital anxiety and depression scale
|
At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months)
|
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：Stine Estrup, MD、Zealand University Hospital
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 (实际的)
2018年1月1日
初级完成 (实际的)
2019年5月3日
研究完成 (实际的)
2019年5月3日
研究注册日期
首次提交
2017年1月10日
首先提交符合 QC 标准的
2017年1月25日
首次发布 (估计)
2017年1月31日
研究记录更新
最后更新发布 (实际的)
2019年7月5日
上次提交的符合 QC 标准的更新
2019年7月3日
最后验证
2018年7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.