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
- 2
- 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
- •Participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. Existing medical records, per physician discretion and low back examinations will confirm diagnosis. This will be determined over the phone during the (pre) screening and at study session 1, and will not be contingent on MRI.
- •Participants must be between the ages of 18-65 years.
- •Participants must rate their daily chronic pain intensity at a 3 or greater on 0-10 visual analog scale.
- •Participants must have experienced their radicular pain for at least 3 months duration.
- •Participants must be right-handed.
- •Participants must have no prior meditative experience
排除标准
- •Participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period.
- •Participants must not have had back surgery within the last year before their enrollment into the study.
- •Participants must not have had any other sensory or motor deficits that precludes participation in this study.
- •Participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, a personal history of psychosis.
- •Participants must not have metal implants including ferrous arterial stints or coils, spinal stimulators, pacemakers, or defibrillators, permanently implanted hearing aides, bullets, BBs, or pellets, retinal eye implants, infusion pump for insulin or other medicines, ferrous surgical clips, staples, metal sutures, orthopedic hardware above or including the shoulders, body piercings that cannot be removed.
- •Participants must not be claustrophobic.
- •Participants must not produce negative straight leg test (i.e. a test is considered positive when the person reports reproducible pain at 40 degrees of hip flexion or less).
- •Participants must not be pregnant
- •Participants must not be over 275 pounds
研究组 & 干预措施
mindfulness group
Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught that perceived sensory events are "momentary" and "fleeting" and do not require further evaluation. There will be an emphasis on breath focus and altering one's perspective of discursive sensory events. This intervention has been found to reliably attenuate the subjective experience of pain.
干预措施: mindfulness training (Behavioral)
non-mindfulness group
Study volunteers will participate in a six-session meditation training regimen. In brief, subjects will be taught to take deep breaths and relax.
干预措施: non-mindfulness training (Behavioral)
book-listening
Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 6 session intervention is meant to provide the control attention to the facilitator, room setting, social support, conditioning, and the time elapsed during the other respective interventions. We do not expect that this group will demonstrate significant cerebral blood flow changes as a function of the intervention.
干预措施: book-listening (Behavioral)
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