Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
研究概览
简要总结
The purpose of this study is to see if mindfulness, a form of mental training, or listening to a book alters brain activation in response to raising your leg that may produce the feeling of pain. A technique called functional magnetic resonance imaging (fMRI) allows scientists to determine which parts of the brain are active during a particular task. This study will provide new information about how mindfulness affects the brain.
详细描述
To determine if mindfulness meditation-induced reductions in chronic low back pain (cLBP) patients will be associated with greater anterior insula (aINS), orbitofrontal cortex (OFC), subgenual anterior cingulate cortex (sgACC), and/or thalamic deactivation when compared to rest, the sham-mindfulness meditation and the book-listening control groups. One-hundred and twenty individuals will be randomized to a mindfulness meditation (n=40), non-mindfulness meditation (n=40) and book-listening-control (n=40). Each participants will be administered noxious heat and the chronic low back pain evoking, straight leg raise test during fMRI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Only the study physician, research coordinator, and intervention facilitators will be aware of group assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
时间窗: There will be up to 2 fMRI sessions (Visit 2, and 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Changes in cerebral blood flow will be assessed during pseudo continuous arterial spin labeling fMRI during their respective manipulations.
次要结局
- Respiration Rate(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Visual Analog Scale Pain Ratings(Baseline and 3 fMRI sessions (Visit 1, 2, 9, and 16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- PROMIS Pain Behavior Measure(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Freiburg Mindfulness Inventory(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Numerical Pain Ratings(Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Blood Oxygen Dependent Signaling(Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Pain Catastrophizing Scale(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Five Facet Mindfulness Questionnaire(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Brief Pain Inventory(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Beck Depression Inventory(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Roland-Morris Disability Questionnaire(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
- Cohen Perceived Stress Scale(There will be up to 2 fMRI sessions (Visit 2, 9). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.)
研究者
Fadel Zeidan
Associate Professor
University of California, San Diego