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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness | Experimental | A well-validated mindfulness meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. |
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| Meditation | Experimental | A validated meditation-based therapy [8 sessions] is used to teach patients to independently practice meditation to cope with pain. |
|
| Usual Care | Active Comparator | Patients will receive usual medical care for chronic low back pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Meditation | Behavioral | Participants will complete 8 sessions of meditation training with therapy as a means of coping with chronic pain and opioid-related issues. |
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| 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) |
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Heart rate variability | Changes in heart rate variability (HRV) measured with a 3-lead ECG. | At baseline and at post-treatment (8 weeks) |
| Cue-reactivity | Cue-reactivity as evidenced by blood oxygenation level dependent (BOLD) signaling and cue-reactivity ratings during cue-exposure |
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eric Garland, PhD | Contact | 858-822-4092 | eric.garland@socwk.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| Eric Garland, PhD | University of Utah | Principal Investigator |
| Fadel Zeidan, PhD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Diego | Recruiting | La Jolla | California | 92093 | United States |
The research team will adhere to the NIH Grants Policy on Availability of Research Results: Publications, Intellectual Property Rights, and Sharing Biomedical Research Resources.
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Data will become available after the publication of the main study findings from the final data set. Data will be made permanently available.
Data will be made available upon reasonable request with a signed data access agreement.
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D019122 | Meditation |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026443 | Spiritual Therapies |
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| Usual care | Other | Participants will receive usual care for chronic low back pain (e.g., analgesic medication, pain management consultant from a physician, physical therapy, etc.). |
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| 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 |
| At baseline and at post-treatment (8 weeks) |
| Center on Mindfulness and Integrative Health Intervention Development | Active, not recruiting | Salt Lake City | Utah | 84108 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D012064 |
| Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |