Mindfulness and Chronic Low Back Pain

Study Overview
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Brief Summary
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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
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You have been asked to participate in this study because you are interested in learning mindfulness and have been diagnosed with chronic low-back pain. Your participation is voluntary. We will randomly assign 40 subjects to each group for the initiation of the final phase of the study. Randomization means that you have a one in two chance of being assigned to the mindfulness meditation training or book-listening control intervention. Your assignment is based on chance rather than a medical decision made by the researchers.

Official Title
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Brain Mechanisms Supporting Mindfulness-based Chronic Pain Relief

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Behavioral: Meditation training
* Behavioral: Meditatin training
* Behavioral: Book Listening Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This intervention study will utilize an unbiased randomized study design. Pain intensity and pain unpleasantness ratings will be assessed using visual analog scales (11 point) obtained before and after all sessions where low back pain is induced. Study volunteers will be randomized and subsequently participate in a twelve session mindfulness meditation or book-listening control regimen. Study volunteers will be required to complete three MRI scans over the course of the study.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation Group<br>Study volunteers will participate in a twelve-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. | Behavioral: Meditation training<br>* 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.<br>* Other names: mental training;|
| Active Comparator: Meditatin Group<br>Study volunteers will participate in a twelve-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. | Behavioral: Meditatin training<br>* A well-validated brief meditation-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.<br>* Other names: mental training;|
| Active Comparator: Book Listening Control Group<br>Study volunteers will listen to an audio recording of the Natural History of Selborne across each session.This 12 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. | Behavioral: Book Listening Control<br>* Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | There will be up to 3 fMRI sessions (Visit 2, 9, and 16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments.. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Ratings | 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 | 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. | 
| 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. | There will be up to 3 fMRI sessions (Visit 2, 9, and 16). 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. | 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. | 
| Profile of Mood States Form | 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. | 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. | 
| Patients' Global Impression of Change | 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. | 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. | 
| Pain Self Efficacy Questionnaire | 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. | 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 29-Item Profile | 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. | 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 | 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. | 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 Quality Measure | 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. | 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. | 
| Chronic Pain Acceptance Questionnaire | 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. | 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. | 
| State Anxiety Inventory | 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. | Baseline, all intervention sessions, and 3 fMRI sessions (Visit 1-16). 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. | 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. | 
| SF 12 Health Survey | 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. | 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. | 
| 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. | 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. | 
| 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. | 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. | 
| 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. | 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. | 
| 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. | 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. | 
| Pittsburgh Sleep Quality Index | 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. | 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. | 
| 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. | 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. | 
| Positive and Negative Affect Scale | 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. | 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. | 
| Perceived Intervention Effectiveness | This measure will be assessed with a VAS (0 = not effective at all; 10= most effective imaginable) for each intervention session's respective manipulation. | All 12 intervention sessions, MRI 2, and MRI 3 (Visit 3-16). Active enrollment provides up to 8 weeks to complete all study interventions, scans, and assessments. | 
| Social Connectedness Scale | 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. | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, fMRI, Pain, Low Back, Radicular