Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic Low Back Pain
- Sponsor
- University of California, San Diego
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Fadel Zeidan
Associate Professor
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
Time Frame: 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.
Secondary Outcomes
- 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.)