Chronic Low Back Pain
Conditions
Keywords
Mindfulness, fMRI, Pain, Low Back, Radicular
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.
Interventions
BEHAVIORALmindfulness training
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.
BEHAVIORALnon-mindfulness training
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.
BEHAVIORALbook-listening
Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Only the study physician, research coordinator, and intervention facilitators will be aware of group assignment.
Intervention model description
This intervention study will utilize an unbiased randomized study design. Pain intensity and pain unpleasantness ratings will be assessed using before and after all sessions where low back pain is induced. Study volunteers will be randomized and subsequently participate in a six session mindfulness meditation, non-mindfulness meditation or book-listening control regimen. Study volunteers will be required to complete two MRI scans over the course of the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
are: * 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cerebral Blood Flow (average blood perfusion; mL blood/100 grams tissue/minute) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Respiration rate will be collected and recorded on a Biopac respiratory transducer. Changes in respiration rate could be predictive of analgesia and health promotion. |
| 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. | 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 |
| Numerical Pain Ratings | Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments. | 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 |
| Blood Oxygen Dependent Signaling | Two fMRI sessions. Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments. | 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 |
| 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. | 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. |
| 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. | 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. |
| 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. | This is an 8-item assessment widely used to measure clinical pain. Higher scores reflect a higher severity rating of pain. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
| 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. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Perceived Intervention Effectiveness | 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. | This measure will be assessed with a VAS (0 = not effective at all; 10= most effective imaginable) for each intervention session's respective manipulation. |
| Positive and Negative Affect 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. | This is a 20-item self-report assessment used to assess positive and negative affect in a participant. A rating between very slightly or not at all (1) to extremely (5) is provided in response to each statement. Higher scores indicate a greater level of positive affect, and a lower score reveals a greater level of negative affect. |
| Pittsburgh Sleep Quality Index | 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. | This is a 10-item assessment designed to measure quality of sleep. This measure is scored along a 5-point Likert scale with values ranging from 0 to 5, specific ratings associated with particular items. Scores on this assessment range from 0 to 28, with higher values reflecting greater levels of insomnia. |
| SF 12 Health Survey | 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. | This is a 12-item version of the SF-36 item Health Survey designed to assess general mental and physical functioning, and overall health-related quality of life. Scores on this assessment range from 0 to 100, where a higher score indicates a higher level of overall health. |
| State Anxiety 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. | This inventory is a 20-item assessment used to measure a subject's state of anxiety. A numeric value between 1 (Not at all) and 4 (Very Much So) is provided in response to each statement. The range of scores for this test is between 20 and 80, with higher scores reflecting higher estimates of anxiety. |
| PROMIS Pain Quality 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. | This is a 5-item questionnaire that measures sensory quality of pain experience (throbbing, aching, etc). A numeric value between 1 (not at all) and 5 (very much) is provided in response to each statement. Higher scores indicate a greater quality of pain. |
| PROMIS 29-Item Profile | 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. | This is a 29-item generic health-related survey that assesses 7 domains with 4-items in each domain: depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participant in social roles/activities. Higher scores represent different outcomes based on domain. Higher scores on symptom-oriented domains represent worse symptomatology, but higher scores on function-oriented domains represent better functioning. |
| Patients' Global Impression of Change | 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. | This is a self-report assessment measured on a 7-point scaled designed to evaluate perceived improvement over trial/efficacy of treatment. Options range from no change to a great deal better, and a considerable improvement that has made all the difference. Higher ratings indicate greater impressions of change. |
| Profile of Mood States Form | 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. | This is a 40-item core measure of emotional functioning and includes 6 mood states: tension-anxiety, depression-dejection, anger-hostility, vigor-activity, fatigue-inertia, and confusion-bewilderment. A numeric value between 1 (not at all) and 5 (extremely) is provided in response to each statement. Total mood disturbance scoring is calculated by summing the totals for the negative subscales and then subtracting the totals for the positive subscales. |
| Pain Self Efficacy 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. | This is a 10-item questionnaire that's designed to assess the confidence in people with ongoing pain have in performing activities while in pain. The option of either not at all confident or completely confident is posed after each item. Scores on this assessment range from 0 to 60, with higher scores indicating stronger self-efficacy beliefs. |
| Chronic Pain Acceptance 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. | This is a 20-item assessment designed to measure acceptance of pain. Items are rated on a 7-point scale from 0 (never true) to 6 (always true). Higher scores indicate higher levels of acceptance. |
| Social Connectedness 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. | This is a 20-item assessment designed to measure social connectedness, an attribute of the self that reflects cognitions of enduring interpersonal closeness with the social world, in participants. Higher scores on the Social Connectedness Scale reflect a stronger sense of social connectedness, there are no sub-scales. The minimum score is 20 and the maximum score is 120. |
Countries
United States
Outcome results
None listed