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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
120
A well-validated brief mindfulness-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
A well-validated brief meditation-based mental training regimen \[20 min/session(s)\] will be used to teach patients to independently practice deep breathing. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.
UC San Diego
La Jolla, California, United States
UC San Diego Center for Functional MRI
La Jolla, California, United States
Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute)
Changes in cerebral blood flow will be assessed during pseudo continuous arterial spin labeling fMRI during their respective manipulations.
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.
Visual Analog Scale Pain Ratings
Changes in visual analog scale (VAS) pain ratings will be assessed in response to the straight leg raise test and lying supine in the MRI scanner. Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher numbers correspond to higher perceived pain
Time frame: 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.
Numerical Pain Ratings
Changes in numerical pain ratings (NRS) will be assessed in response to the straight leg raise test and lying supine in the MRI scanner. Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher numbers correspond to higher perceived pain
Time frame: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
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Blood Oxygen Dependent Signaling
Changes in BOLD fMRIacquired during noxious heat stimulation during rest and manipulations Psychophysical Assessment of Pain: As previously in all of our previous pain studies, pain intensity and unpleasantness ratings will be assessed with a Visual Analog Scale. These scales 1) provide reliably separate assessment of experimental and clinical pain intensity and unpleasantness, 2) are internally consistent, and 3) approximate ratio scale measurement accuracy. The minimum rating ("0") is designated as "no pain" whereas the maximum ("10") is labeled as "most intense imaginable" or "most unpleasant imaginable". Higher numbers correspond to higher perceived pain
Time frame: Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.
Respiration Rate
Respiration rate will be collected and recorded on a Biopac respiratory transducer. Changes in respiration rate could be predictive of analgesia and health promotion.
Time frame: 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
This is a 39-item multidimensional measure of trait mindfulness and includes five subscales: non-reactivity, nonjudgment, describing, observing, and acting with awareness. A numeric value between 1 (never or very rarely true) and 5 (very often or always true) is provided in response to each statement.
Time frame: 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.
PROMIS Pain Behavior Measure
This is a 5-item questionnaire that measures complaints of suffering, verbal or nonverbal (i.e. such as when I am in pain I squirm) from the past 7 days. Scoring for this measure is item-content dependent.
Time frame: 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
This is an 8-item assessment widely used to measure clinical pain. Higher scores reflect a higher severity rating of pain.
Time frame: 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.
Pain Catastrophizing Scale
This is a 13-item questionnaire with 3 subscales assessing rumination, magnification, and helplessness in patients. A numeric value between 0 (not at all) and 4 (all the time) is provided in response to each statement. Scores on this assessment range from 0 to 52, with higher values reflecting more salient impacts of pain on one's day to day experience.
Time frame: 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
This is a 21-item standard assessment used to measure clinical depression. Scores on this assessment range from 0 to 63, where higher scores indicate higher levels of depression.
Time frame: 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
This is a 14-item standard mindfulness scale to measure potential changes in mindfulness before and after intervention. A rating between "rarely" (0) to "often" (4) is provided in response to each statement.
Time frame: 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
This is a critical assessment for assessing the functional impact of chronic low back pain. Scores on this assessment range from 0 to 24, where higher scores indicate greater disability and limited functioning due to pain.
Time frame: 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
The CPS is a series of 10 temporally constrained (i.e. in the last month) questions meant to ascertain the relative frequency of stressors in one's life, ranging from never (scored as 0) to very often (scored as 4). All positively stated questions are reversed scored and then all items are summed to yield a final estimate of stress. The higher the score the higher the level of stress.
Time frame: 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.