Pain, Brain and Mobility Study (PBAM)
2016年2月16日 更新者:University of Florida
Central and Peripheral Mechanisms Predicting Clinical Pain and Physical Performance in Older Adults
The aim of this project will be to document the central and peripheral mechanisms, which may predict clinical pain characteristics and associated physical performance in older adults.
Although chronic pain is common among older adults, there is limited understanding on the processing of pain and the mechanisms by which it affects physical function in these individuals.
The first aim of this study will be to examine predictors of clinical pain in older adults.
These will include a comprehensive somatosensory assessment battery including mechanical and thermal detection and pain thresholds in older adults with and without chronic pain.
The investigators will also assess basal cognitive and physical function to determine their associations with chronic pain.
Finally, brain structure and function will be assessed in these older adults with and without pain.
研究概览
地位
撤销
详细说明
The purpose of this research study is to learn more about how pain in older individuals changes the brain and impacts a person's mobility and function.
Pain is influenced by biology (like hormones), psychology (thoughts and feelings), and habits (like sleep or exercise) that may make older adults more likely to have higher or lower levels of pain.
研究类型
观察性的
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
65年 及以上 (年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Older adults
描述
Inclusion Criteria:
- Age 65 years and older
- Willingness to participate in all study procedures
- Cognitively intact as defined by 3MS score > 80
Exclusion Criteria:
- Failure to provide informed consent;
- Contraindications to MRI, such as claustrophobia, heart pacemaker / defibrillator, heart valve prosthesis, aneurysm clip, metallic stent, neurostimulation system, cochlear implants or inner ear prosthesis, insulin pump or other infusion pump, metal slivers in the orbital area/eye socket
- Active treatment for cancer or history of cancer in the past year
- Severe cardiac disease, including New York Heart Association (NYHA) Class III or IV congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest or stroke, use of a cardiac defibrillator, or uncontrolled angina;
- Previous stroke with upper and/or lower extremities involvement within the last 6 months
- History of life-threatening cardiac arrhythmias, stroke, severe Parkinson's disease or severe neurological disorders likely to interfere with physical function
- Renal disease requiring dialysis
- Lung disease requiring steroids
- Inability to reliably rate pain intensity
- Current use of tobacco products
- Uncontrolled hypertension (BP of greater than 150/99 mm Hg)
- Serious systemic disease that restrict normal daily activities
- Neurological problems with significant changes in somatosensory and pain perception at the intended stimulation sites,
- Uncontrolled psychiatric condition (e.g., experiencing symptoms of schizophrenia, bipolar disorder, etc.) or hospitalization within the preceding year for psychiatric illness
- Daily use of narcotic medication
- Lower extremity amputation
- Uncontrolled diabetes (self-reported medication use and/or HA1C value)
- A known diagnosis of dementia
- Inability to communicate because of severe hearing loss or speech disorder;
- Severe visual impairment, which would preclude completion of the assessments and/or intervention.
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
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Chronic Pain Group
Participants that experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done.
In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
|
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
|
|
No Chronic Pain Group
Participants that do not experience chronic pain will have the following procedures performed: A sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin; Pressure sense will be produced by a device that will be pressed against the skin for several seconds; Pinprick pressure will be applied to determine if the pain can be rated; a Physical Performance test will be performed; and an magnetic resonance imaging (MRI) will be done.
In addition, blood sample, blood pressure, heart rate, and skin temperature will be taken during the procedures.
|
Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
Participants in both groups will have a Physical Performance test.
Participants in both groups will have an magnetic resonance imaging (MRI).
Participants in both groups will have blood samples taken.
|
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 |
|---|---|---|
|
Brain magnetic resonance imaging (MRI)
大体时间:Baseline and 12 months later
|
Differences in the MRI on the brain scans of participants with greater pain severity
|
Baseline and 12 months later
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Inflammatory markers in blood samples
大体时间:Baseline
|
To test the markers of pro-inflammatory (IL-1b, tumor necrosis factor (TNF-a)) and anti-inflammatory (IL-4, IL-10) with participants more sensitive to pain than the ones less sensitive to pain.
|
Baseline
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mobility (gait speed)
大体时间:Baseline and 12 months
|
Inverse dynamics will be used to calculate gait speed.
|
Baseline and 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:Yenisel Cruz-Almeida, MSPH, PhD、University of Florida
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4月1日
初级完成 (实际的)
2015年4月1日
研究完成 (实际的)
2015年4月1日
研究注册日期
首次提交
2014年9月2日
首先提交符合 QC 标准的
2014年9月11日
首次发布 (估计)
2014年9月15日
研究记录更新
最后更新发布 (估计)
2016年2月18日
上次提交的符合 QC 标准的更新
2016年2月16日
最后验证
2016年2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.