Neural Mechanisms of Meditation for Opioid-Treated Chronic Low Back Pain

Study Overview
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Brief Summary
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The purpose of this research study is to see how a mindfulness meditation-based intervention affects pain. Specifically, we are interested in understanding the pain-relieving brain mechanisms of mindfulness meditation-based therapy for patients with opioid-treated chronic low back pain.

Official Title
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Neural Mechanisms of Meditation-Based Interventions for Chronic Low Back Pain

Conditions
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Low Back Pain, Opioid Use

Intervention / Treatment
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* Behavioral: Meditation
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) men/women 18-65 years of age; 2) current chronic low back pain classified according to the NIH Pain Consortium task force research standards for chronic low back pain (pain on at least half the days in the past 6 months); usual back pain ≥3 on 0-10 scale with opioid medication; and 4) current use of prescription opioids for ≥3 months. Exclusion Criteria: 1) Prior experience with MBSR, MBCT, MORE, or extensive involvement in any standardized meditation training, 2) current cancer diagnosis, 3) suicide intent or attempt in the past 30 days, 4) psychosis or moderate/severe non-opioid substance use disorder in past 6 months; 5) persons with any electronic objects or certain metal objects in their head or body that are incompatible with MRI; 6) those who have had an abnormal brain MRI in the past; 7) those unable to lie still on their back for 1 to 1.5 hours; and 8) pregnancy.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness<br>A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. | Behavioral: Meditation<br>* Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.<br>Other: Usual care<br>* Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).<br>|
| Experimental: Meditation<br>A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. | Behavioral: Meditation<br>* Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues.<br>Other: Usual care<br>* Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).<br>|
| Active Comparator: Usual Care<br>Patients will receive usual medical care for chronic low back pain. | Other: Usual care<br>* Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood oxygenation level dependent (BOLD) signaling | Changes in blood oxygenation levels to thermally noxious stimuli (48°C) will be assessed. | At baseline and at post-treatment (8 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Ratings | 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. | At baseline and at post-treatment (8 weeks) | 
| Chronic pain symptoms | Scores on Brief Pain Inventory, with higher scores indicating higher pain severity (min 0, max 10) | At baseline, post-treatment (8 weeks), and 3-month follow-up | 
| Opioid dose | Opioid dose as assessed with Timeline Followback Procedure | At baseline, post-treatment (8 weeks), and 3-month follow-up | 
| Pain catastrophizing | 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. | At baseline, post-treatment (8 weeks), and 3-month follow-up | 
| Self-transcendence | Self-transcendence measured by Nondual Awareness Dimensional Assessment, with higher scores indicating higher self-transcendence (min 13, max 65) | At baseline, post-treatment (8 weeks), and 3-month follow-up | 
| Mindful reinterpretation of pain sensations | Mindful reinterpretation of pain sensations measured by the Mindful Reinterpretation of Pain Sensations Scale, with higher scores indicating higher reinterpretation of pain sensations (min 0, max 45) | At baseline, post-treatment (8 weeks), and 3-month follow-up | 
| Trait mindfulness | 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. | At baseline, post-treatment (8 weeks), and 3-month follow-up |