Test Retest Reliability of Offset Analgesia and Onset Hyperalgesia Paradigm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 2
- 主要终点
- Test retest reliability of offset analgesia and onset hyperalgesia
研究概览
简要总结
The goal of this study is to measure the test retest reliability of offset analgesia (OA) and onset hyperalgesia (OH) across multiple study visits. OA and OH are quantitative sensory tests (QST) thought to measure how the brain modulates pain. This study will use a heat thermode to induce OA and OH in healthy, pain-free volunteers across 3 study visits. Additional QST measures and survey data relevant to pain modulation will be collected. This study lays the foundation required to use OA and OH as tools to measure pain modulation in clinical trials. Following their validation, we anticipate that OA and OH will serve as predictive and therapeutic biomarkers, which will aid both in the development of novel analgesics and in treatment selection leading to the personalization of pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers with no chronic pain issues who can understand the study procedures
排除标准
- •History of chronic pain
- •Current significant pain disorder
- •Active ongoing pain every day that is acute or chronic in duration
- •Recent history of migraine (1 attack in last 24 months)
- •Lifetime history mood disorders (anxiety, depression, bipolar) or psychotic disorders.
- •Subjects taking psychotropics (e.g. benzodiazepines, antidepressants), or medications known to affect the autonomic nervous system (e.g. beta-receptor agonists or antagonists) will be excluded.
- •Cognitive impairment affecting the ability to provide informed consent, understand directions, and participate in study procedures
- •Uncontrolled or unstable medical disorder preventing participation in study procedures
- •Pregnancy
- •Tattoos on forearm
- •History of brain surgery
- •Nonambulatory status
- •Heart problems such as an irregular heart beat or coronary artery disease
- •Neurological problems such as seizure, fainting spells, recurrent severe headache, stroke, transient ischemic attack
- •High blood pressure
- •Severe liver disease
- •Severe gastrointestinal disease
- •Chronic severe infectious disease (e.g. HIV/AIDS)
结局指标
主要结局
Test retest reliability of offset analgesia and onset hyperalgesia
时间窗: 4 weeks post baseline
Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at 4 weeks after baseline
Differences in brain region activation- QST (quantitative sensory tests)
时间窗: baseline
Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures.
Offset analgesia and onset hyperalgesia
时间窗: baseline
Pain intensity difference during heat stimuli measured on a 0-100 sliding scale (0 is no pain, 100 is the most intense pain imaginable) at baseline
Test retest reliability in brain region activation- QST (quantitative sensory tests)
时间窗: 4 weeks post baseline
Difference in brain region activation (as measured by oxygenated hemoglobin, HbO) between central nervous system inhibition and control stimuli during QST procedures at 4 weeks after baseline
次要结局
- Questionnaire score- STAI Y1 post testing(4 weeks after baseline)
- Questionnaire score- Generalized Anxiety Disorder 2-item (GAD-2)(baseline)
- Pain intensity(4 weeks after baseline)
- Differences in resting fNIRS signaling(baseline)
- Questionnaire score- State Trait Anxiety Inventory (STAI) Y1-2(baseline)
- Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2 post testing(4 weeks after baseline)
- Questionnaire score- Pain Catastrophizing Scale (PCS)(baseline)
- Questionnaire score- Situational Pain Catastrophizing Scale post testing(4 weeks after baseline)
- Questionnaire score- Beck Depression Inventory-II (BDI-II)(baseline)
- Questionnaire score- Multidimensional Assessment of Interoceptive Awareness (MAIA) Version 2(baseline)
研究者
Benedict Alter
Assistant Professor
University of Pittsburgh